42 CFR 493.841 - Standard; Routine chemistry.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 5 2011-10-01 2011-10-01 false Standard; Routine chemistry. 493.841 Section 493.841 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES... These Tests § 493.841 Standard; Routine chemistry. (a) Failure to attain a score of at least 80 percent...

42 CFR 493.841 - Standard; Routine chemistry.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 42 Public Health 5 2013-10-01 2013-10-01 false Standard; Routine chemistry. 493.841 Section 493.841 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES... These Tests § 493.841 Standard; Routine chemistry. (a) Failure to attain a score of at least 80 percent...

42 CFR 493.841 - Standard; Routine chemistry.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 42 Public Health 5 2014-10-01 2014-10-01 false Standard; Routine chemistry. 493.841 Section 493.841 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES... These Tests § 493.841 Standard; Routine chemistry. (a) Failure to attain a score of at least 80 percent...

42 CFR 493.841 - Standard; Routine chemistry.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 42 Public Health 5 2012-10-01 2012-10-01 false Standard; Routine chemistry. 493.841 Section 493.841 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES... These Tests § 493.841 Standard; Routine chemistry. (a) Failure to attain a score of at least 80 percent...

Clinical chemistry in higher dimensions: Machine-learning and enhanced prediction from routine clinical chemistry data.

PubMed

Richardson, Alice; Signor, Ben M; Lidbury, Brett A; Badrick, Tony

2016-11-01

Big Data is having an impact on many areas of research, not the least of which is biomedical science. In this review paper, big data and machine learning are defined in terms accessible to the clinical chemistry community. Seven myths associated with machine learning and big data are then presented, with the aim of managing expectation of machine learning amongst clinical chemists. The myths are illustrated with four examples investigating the relationship between biomarkers in liver function tests, enhanced laboratory prediction of hepatitis virus infection, the relationship between bilirubin and white cell count, and the relationship between red cell distribution width and laboratory prediction of anaemia. Copyright © 2016 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

Effects of two types of medical contrast media on routine chemistry results by three automated chemistry analyzers.

PubMed

Park, Yu Jin; Rim, John Hoon; Yim, Jisook; Lee, Sang-Guk; Kim, Jeong-Ho

2017-08-01

The use of iodinated contrast media has grown in popularity in the past two decades, but relatively little attention has been paid to the possible interferential effects of contrast media on laboratory test results. Herein, we investigate medical contrast media interference with routine chemistry results obtained by three automated chemistry analyzers. Ten levels of pooled serum were used in the study. Two types of medical contrast media [Iopamiro (iopamidol) and Omnipaque (iohexol)] were evaluated. To evaluate the dose-dependent effects of the contrast media, iopamidol and iohexol were spiked separately into aliquots of serum for final concentrations of 1.8%, 3.6%, 5.5%, 7.3%, and 9.1%. The 28 analytes included in the routine chemistry panel were measured by using Hitachi 7600, AU5800, and Cobas c702 analyzers. We calculated the delta percentage difference (DPD) between the samples and the control, and examined dose-dependent trends. When the mean DPD values were compared with the reference cut-off criteria, the only uniformly interferential effect observed for all analyzers was in total protein with iopamidol. Two additional analytes that showed trends toward interferential effects only in few analyzers and exceeded the limits of the allowable error were the serum iron and the total CO 2 . The other combinations of analyzer and contrast showed no consistent dose-dependent propensity for change in any analyte level. Our study suggests that many of the analytes included in routine chemistry results, except total protein and serum iron, are not significantly affected by iopamidol and iohexol. These results suggest that it would be beneficial to apply a flexible medical evaluation process for patients requiring both laboratory tests and imaging studies, minimizing the need for strict regulations for sequential tests. Copyright © 2017 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

Clinical chemistry through Clinical Chemistry: a journal timeline.

PubMed

Rej, Robert

2004-12-01

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

Comparison of pneumatic tube system with manual transport for routine chemistry, hematology, coagulation and blood gas tests.

PubMed

Pupek, Alex; Matthewson, Beverly; Whitman, Erin; Fullarton, Rachel; Chen, Yu

2017-08-28

The pneumatic tube system (PTS) is commonly used in modern clinical laboratories to provide quick specimen delivery. However, its impact on sample integrity and laboratory testing results are still debatable. In addition, each PTS installation and configuration is unique to its institution. We sought to validate our Swisslog PTS by comparing routine chemistry, hematology, coagulation and blood gas test results and sample integrity indices between duplicate samples transported either manually or by PTS. Duplicate samples were delivered to the core laboratory manually by human courier or via the Swisslog PTS. Head-to-head comparisons of 48 routine chemistry, hematology, coagulation and blood gas laboratory tests, and three sample integrity indices were conducted on 41 healthy volunteers and 61 adult patients. The PTS showed no impact on sample hemolysis, lipemia, or icterus indices (all p<0.05). Although alkaline phosphatase, total bilirubin and hemoglobin reached statistical significance (p=0.009, 0.027 and 0.012, respectively), all had very low average bias which ranged from 0.01% to 2%. Potassium, total hemoglobin and percent deoxyhemoglobin were statistically significant for the neonatal capillary tube study (p=0.011, 0.033 and 0.041, respectively) but no biases greater than ±4% were identified for these parameters. All observed differences of these 48 laboratory tests were not clinically significant. The modern PTS investigated in this study is acceptable for reliable sample delivery for routine chemistry, hematology, coagulation and blood gas (in syringe and capillary tube) laboratory tests.

Reference values of clinical chemistry and hematology parameters in rhesus monkeys (Macaca mulatta).

PubMed

Chen, Younan; Qin, Shengfang; Ding, Yang; Wei, Lingling; Zhang, Jie; Li, Hongxia; Bu, Hong; Lu, Yanrong; Cheng, Jingqiu

2009-01-01

Rhesus monkey models are valuable to the studies of human biology. Reference values for clinical chemistry and hematology parameters of rhesus monkeys are required for proper data interpretation. Whole blood was collected from 36 healthy Chinese rhesus monkeys (Macaca mulatta) of either sex, 3 to 5 yr old. Routine chemistry and hematology parameters, and some special coagulation parameters including thromboelastograph and activities of coagulation factors were tested. We presented here the baseline values of clinical chemistry and hematology parameters in normal Chinese rhesus monkeys. These data may provide valuable information for veterinarians and investigators using rhesus monkeys in experimental studies.

Lipemia interferences in routine clinical biochemical tests.

PubMed

Calmarza, Pilar; Cordero, José

2011-01-01

Lipemic specimens are a common and frequent, but yet unresolved problem in clinical chemistry, and may produce significant interferences in the analytical results of different biochemical parameters. The aim of this study was to examine the effect of lipid removal using ultracentrifugation of lipemic samples, on some routine biochemistry parameters. Among all the samples obtained daily in our laboratory, the ones which were visibly muddy were selected and underwent to a process of ultracentrifugation, being determined a variety of biochemical tests before and after ultracentrifugation. A total of 110 samples were studied. We found significant differences in all the parameters studied except for total bilirubin, glucose, gamma-glutamyl transferase (GGT) and aspartate aminotransferase (AST). The greatest differences in the parameters analyzed were found in the concentration of alanine aminotransferase (ALT) (7.36%) and the smallest ones in the concentration of glucose (0.014%). Clinically significant interferences were found for phosphorus, creatinine, total protein and calcium. Lipemia causes clinically significant interferences for phosphorus, creatinine, total protein and calcium measurement and those interferences could be effectively removed by ultracentrifugation.

Evaluation of the BD Vacutainer(®) RST blood collection tube for routine chemistry analytes: clinical significance of differences and stability study.

PubMed

Kocijancic, Marija; Cargonja, Jelena; Delic-Knezevic, Alma

2014-01-01

Preanalytical variables account for most of laboratory errors. There is a wide range of factors that affect the reliability of laboratory report. Most convenient sample type for routine laboratory analysis is serum. BD Vacutainer(®) Rapid Serum Tube (RST) (Becton, Dickinson and Company, Franklin Lakes, NJ, USA) blood collection tube provides rapid clotting time allowing fast serum separation. Our aim was to evaluate the comparability of routine chemistry parameters in BD Vacutainer(®) RST blood collection tube in reference with the BD Vacutainer(®) Serum Separating Tubes II Advance Tube (SST) (Becton, Dickinson and Company, Franklin Lakes, NJ, USA). Blood specimens were collected from 90 participants for evaluation on its results, clotting time and stability study of six routine biochemistry parameters: glucose (Glu), aspartate aminotransferase (AST), alanine aminotransferase (ALT), calcium (Ca), lactate dehidrogenase (LD) and potassium (K) measured with Olympus AU2700 analyzer (Beckman Coulter, Tokyo, Japan). The significance of the differences between samples was assessed by paired t-test or Wilcoxon Matched-Pairs Rank test after checking for normality. Clotting process was significantly shorter in the RSTs compared to SSTs (2.49 min vs. 19.47 min, respectively; P < 0.001). There was a statistically significant difference between the RST and SST II tubes for glucose, calcium and LD (P < 0.001). Differences for glucose and LD were also clinically significant. Analyte stability studies showed that all analytes were stable for 24 h at 4 °C. Most results (except LD and glucose) from RST are comparable with those from SST. In addition, RST tube provides shorter clotting time.

Can Unmanned Aerial Systems (Drones) Be Used for the Routine Transport of Chemistry, Hematology, and Coagulation Laboratory Specimens?

PubMed

Amukele, Timothy K; Sokoll, Lori J; Pepper, Daniel; Howard, Dana P; Street, Jeff

2015-01-01

Unmanned Aerial Systems (UAS or drones) could potentially be used for the routine transport of small goods such as diagnostic clinical laboratory specimens. To the best of our knowledge, there is no published study of the impact of UAS transportation on laboratory tests. Three paired samples were obtained from each one of 56 adult volunteers in a single phlebotomy event (336 samples total): two tubes each for chemistry, hematology, and coagulation testing respectively. 168 samples were driven to the flight field and held stationary. The other 168 samples were flown in the UAS for a range of times, from 6 to 38 minutes. After the flight, 33 of the most common chemistry, hematology, and coagulation tests were performed. Statistical methods as well as performance criteria from four distinct clinical, academic, and regulatory bodies were used to evaluate the results. Results from flown and stationary sample pairs were similar for all 33 analytes. Bias and intercepts were <10% and <13% respectively for all analytes. Bland-Altman comparisons showed a mean difference of 3.2% for Glucose and <1% for other analytes. Only bicarbonate did not meet the strictest (Royal College of Pathologists of Australasia Quality Assurance Program) performance criteria. This was due to poor precision rather than bias. There were no systematic differences between laboratory-derived (analytic) CV's and the CV's of our flown versus terrestrial sample pairs however CV's from the sample pairs tended to be slightly higher than analytic CV's. The overall concordance, based on clinical stratification (normal versus abnormal), was 97%. Length of flight had no impact on the results. Transportation of laboratory specimens via small UASs does not affect the accuracy of routine chemistry, hematology, and coagulation tests results from selfsame samples. However it results in slightly poorer precision for some analytes.

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

PubMed

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

2004-03-01

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

International year of Chemistry 2011. A guide to the history of clinical chemistry.

PubMed

Kricka, Larry J; Savory, John

2011-08-01

This review was written as part of the celebration of the International Year of Chemistry 2011. In this review we provide a chronicle of the history of clinical chemistry, with a focus on North America. We outline major methodological advances and trace the development of professional societies and journals dedicated to clinical chemistry. This review also serves as a guide to reference materials for those interested in the history of clinical chemistry. The various resources available, in sound recordings, videos, moving images, image and document archives, museums, and websites dedicated to diagnostic company timelines, are surveyed. These resources provide a map of how the medical subspecialty of clinical chemistry arrived at its present state. This information will undoubtedly help visionaries to determine in which direction clinical chemistry will move in the future.

Preanalytical quality in clinical chemistry laboratory.

PubMed

Ahmad, M Imteyaz; Ramesh, K L; Kumar, Ravi

2014-01-01

Haemolysis is usually caused by inadequate specimen collection or preanalytical handling and is suggested to be a suitable indicator of preanalytical quality. We investigated the prevalence of detectable haemolysis in all routine venous blood samples in OPDs and IPDs to identify differences in preanalytical quality. Haemolysis index (HI) values were obtained from a Vitros 5,1 in the routine clinical chemistry laboratory for samples collected in the outpatient department (OPD) collection centres, a hospital, and inpatient departments (IPD). Haemolysis was defined as a HI > or = 15 (detection limit). Samples from the OPD with the highest prevalence of haemolysis were 6.1 times (95% confidence interval (CI) 4.0 - 9.2) more often haemolysed compared to the center with the lowest prevalence. Of the samples collected in primary health care, 10.4% were haemolysed compared to 31.1% in the IPDs (p = 0.001). A notable difference in haemolysed samples was found between the IPDs section staffed by emergency medicine physicians and the section staffed by primary health care physicians (34.8% vs. 11.3%, p = 0.001). The significant variation in haemolysis indices among the investigated units is likely to reflect varying preanalytical conditions. The HI is a valuable tool for estimation and follow-up of preanalytical quality in the health care laboratory.

Clinical chemistry as scientific discipline: historical perspectives.

PubMed

Büttner, J

1994-12-31

The fundamental ideas which underlie clinical chemistry as an independent scientific field were formed over the course of centuries. Exactly 200 years ago the first modern concepts for this discipline were formulated in close connection with the restructuring of medical education during the French Revolution on the one hand, and the emergence of a new idea of a 'clinic' on the other hand. However, not until 1840 was clinical chemistry institutionalized as academic subject and simultaneously integrated into medical teaching. After about 1860, clinical chemistry was practiced by the clinicians themselves in close relationship with clinical activities, yet again with emphasis on teaching. In this period, clinics and hospitals established 'clinical laboratories'. With the start of the 20th century, after biochemistry had developed into an independent scientific field, clinical chemistry continued to evolve in close relationship with that latter discipline. This was particularly true in the United States, where an 'American School of Clinical Biochemistry' emerged which was to greatly influence the field.

Influence of centrifugation conditions on the results of 77 routine clinical chemistry analytes using standard vacuum blood collection tubes and the new BD-Barricor tubes

PubMed Central

Cadamuro, Janne; Mrazek, Cornelia; Leichtle, Alexander B.; Kipman, Ulrike; Felder, Thomas K.; Wiedemann, Helmut; Oberkofler, Hannes; Fiedler, Georg M.; Haschke-Becher, Elisabeth

2017-01-01

Introduction Although centrifugation is performed in almost every blood sample, recommendations on duration and g-force are heterogeneous and mostly based on expert opinions. In order to unify this step in a fully automated laboratory, we aimed to evaluate different centrifugation settings and their influence on the results of routine clinical chemistry analytes. Materials and methods We collected blood from 41 healthy volunteers into BD Vacutainer PST II-heparin-gel- (LiHepGel), BD Vacutainer SST II-serum-, and BD Vacutainer Barricor heparin-tubes with a mechanical separator (LiHepBar). Tubes were centrifuged at 2000xg for 10 minutes and 3000xg for 7 and 5 minutes, respectively. Subsequently 60 and 21 clinical chemistry analytes were measured in plasma and serum samples, respectively, using a Roche COBAS instrument. Results High sensitive Troponin T, pregnancy-associated plasma protein A, ß human chorionic gonadotropin and rheumatoid factor had to be excluded from statistical evaluation as many of the respective results were below the measuring range. Except of free haemoglobin (fHb) measurements, no analyte result was altered by the use of shorter centrifugation times at higher g-forces. Comparing LiHepBar to LiHepGel tubes at different centrifugation setting, we found higher lactate-dehydrogenase (LD) (P = 0.003 to < 0.001) and lower bicarbonate values (P = 0.049 to 0.008) in the latter. Conclusions Serum and heparin samples may be centrifuged at higher speed (3000xg) for a shorter amount of time (5 minutes) without alteration of the analytes tested in this study. When using LiHepBar tubes for blood collection, a separate LD reference value might be needed. PMID:29187797

Influence of centrifugation conditions on the results of 77 routine clinical chemistry analytes using standard vacuum blood collection tubes and the new BD-Barricor tubes.

PubMed

Cadamuro, Janne; Mrazek, Cornelia; Leichtle, Alexander B; Kipman, Ulrike; Felder, Thomas K; Wiedemann, Helmut; Oberkofler, Hannes; Fiedler, Georg M; Haschke-Becher, Elisabeth

2018-02-15

Although centrifugation is performed in almost every blood sample, recommendations on duration and g-force are heterogeneous and mostly based on expert opinions. In order to unify this step in a fully automated laboratory, we aimed to evaluate different centrifugation settings and their influence on the results of routine clinical chemistry analytes. We collected blood from 41 healthy volunteers into BD Vacutainer PST II-heparin-gel- (LiHepGel), BD Vacutainer SST II-serum-, and BD Vacutainer Barricor heparin-tubes with a mechanical separator (LiHepBar). Tubes were centrifuged at 2000xg for 10 minutes and 3000xg for 7 and 5 minutes, respectively. Subsequently 60 and 21 clinical chemistry analytes were measured in plasma and serum samples, respectively, using a Roche COBAS instrument. High sensitive Troponin T, pregnancy-associated plasma protein A, ß human chorionic gonadotropin and rheumatoid factor had to be excluded from statistical evaluation as many of the respective results were below the measuring range. Except of free haemoglobin (fHb) measurements, no analyte result was altered by the use of shorter centrifugation times at higher g-forces. Comparing LiHepBar to LiHepGel tubes at different centrifugation setting, we found higher lactate-dehydrogenase (LD) (P = 0.003 to < 0.001) and lower bicarbonate values (P = 0.049 to 0.008) in the latter. Serum and heparin samples may be centrifuged at higher speed (3000xg) for a shorter amount of time (5 minutes) without alteration of the analytes tested in this study. When using LiHepBar tubes for blood collection, a separate LD reference value might be needed.

Interferences of homogentisic acid (HGA) on routine clinical chemistry assays in serum and urine and the implications for biochemical monitoring of patients with alkaptonuria.

PubMed

Curtis, S L; Roberts, N B; Ranganath, L R

2014-05-01

We have assessed the effect of elevated concentrations of homogentisic acid (HGA) as in alkaptonuria (AKU), on a range of routine chemistry tests in serum and urine. HGA was added to pooled serum and a range of assays was analysed with Roche Modular chemistries. Effects on urine were assessed by diluting normal urine with urine from a patient with AKU, adding HGA to urine and after lowering output of urinary HGA with nitisinone treatment. Serum enzymatic creatinine showed 30% negative interference with 100μmol/L HGA and >50% at 400μmol/L. Serum urate 100 to 480μmol/L was reduced up to 20% at 100 and to 50% with 400μmol/L HGA. Serum cholesterol between 3 and 11mmol/L was reduced by 0.5mmol/L with 400μmol/L HGA. Urine enzymatic creatinine and urate with >2mmol/L HGA showed concentration dependent negative interference up to 80%. A positive interference in urine total protein by benzethonium turbidometric assay was observed, with 10mmol/L HGA equivalent to 1g/L protein. Jaffe creatinine, Na, K, Cl, Mg, Ca, phosphate, ALT, GGT, ALP activities and urea in serum and or urine were not affected by increases in HGA. To avoid interferences by HGA in alkaptonuria concentration of HGA should be established before samples are assayed with peroxidase assays and benzethonium urine protein. Copyright © 2013 The Canadian Society of Clinical Chemists. All rights reserved.

Implementation and application of moving average as continuous analytical quality control instrument demonstrated for 24 routine chemistry assays.

PubMed

Rossum, Huub H van; Kemperman, Hans

2017-07-26

General application of a moving average (MA) as continuous analytical quality control (QC) for routine chemistry assays has failed due to lack of a simple method that allows optimization of MAs. A new method was applied to optimize the MA for routine chemistry and was evaluated in daily practice as continuous analytical QC instrument. MA procedures were optimized using an MA bias detection simulation procedure. Optimization was graphically supported by bias detection curves. Next, all optimal MA procedures that contributed to the quality assurance were run for 100 consecutive days and MA alarms generated during working hours were investigated. Optimized MA procedures were applied for 24 chemistry assays. During this evaluation, 303,871 MA values and 76 MA alarms were generated. Of all alarms, 54 (71%) were generated during office hours. Of these, 41 were further investigated and were caused by ion selective electrode (ISE) failure (1), calibration failure not detected by QC due to improper QC settings (1), possible bias (significant difference with the other analyzer) (10), non-human materials analyzed (2), extreme result(s) of a single patient (2), pre-analytical error (1), no cause identified (20), and no conclusion possible (4). MA was implemented in daily practice as a continuous QC instrument for 24 routine chemistry assays. In our setup when an MA alarm required follow-up, a manageable number of MA alarms was generated that resulted in valuable MA alarms. For the management of MA alarms, several applications/requirements in the MA management software will simplify the use of MA procedures.

21 CFR 862.2170 - Micro chemistry analyzer for clinical use.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Micro chemistry analyzer for clinical use. 862... SERVICES (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Laboratory Instruments § 862.2170 Micro chemistry analyzer for clinical use. (a) Identification. A micro chemistry...

21 CFR 862.2170 - Micro chemistry analyzer for clinical use.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Micro chemistry analyzer for clinical use. 862... SERVICES (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Laboratory Instruments § 862.2170 Micro chemistry analyzer for clinical use. (a) Identification. A micro chemistry...

21 CFR 862.2170 - Micro chemistry analyzer for clinical use.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Micro chemistry analyzer for clinical use. 862... SERVICES (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Laboratory Instruments § 862.2170 Micro chemistry analyzer for clinical use. (a) Identification. A micro chemistry...

21 CFR 862.2170 - Micro chemistry analyzer for clinical use.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Micro chemistry analyzer for clinical use. 862... SERVICES (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Laboratory Instruments § 862.2170 Micro chemistry analyzer for clinical use. (a) Identification. A micro chemistry...

21 CFR 862.2170 - Micro chemistry analyzer for clinical use.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Micro chemistry analyzer for clinical use. 862... SERVICES (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Laboratory Instruments § 862.2170 Micro chemistry analyzer for clinical use. (a) Identification. A micro chemistry...

Reference Intervals of Common Clinical Chemistry Analytes for Adults in Hong Kong.

PubMed

Lo, Y C; Armbruster, David A

2012-04-01

Defining reference intervals is a major challenge because of the difficulty in recruiting volunteers to participate and testing samples from a significant number of healthy reference individuals. Historical literature citation intervals are often suboptimal because they're be based on obsolete methods and/or only a small number of poorly defined reference samples. Blood donors in Hong Kong gave permission for additional blood to be collected for reference interval testing. The samples were tested for twenty-five routine analytes on the Abbott ARCHITECT clinical chemistry system. Results were analyzed using the Rhoads EP evaluator software program, which is based on the CLSI/IFCC C28-A guideline, and defines the reference interval as the 95% central range. Method specific reference intervals were established for twenty-five common clinical chemistry analytes for a Chinese ethnic population. The intervals were defined for each gender separately and for genders combined. Gender specific or combined gender intervals were adapted as appropriate for each analyte. A large number of healthy, apparently normal blood donors from a local ethnic population were tested to provide current reference intervals for a new clinical chemistry system. Intervals were determined following an accepted international guideline. Laboratories using the same or similar methodologies may adapt these intervals if deemed validated and deemed suitable for their patient population. Laboratories using different methodologies may be able to successfully adapt the intervals for their facilities using the reference interval transference technique based on a method comparison study.

Clinical Chemistry of Patients With Ebola in Monrovia, Liberia

PubMed Central

de Wit, Emmie; Kramer, Shelby; Prescott, Joseph; Rosenke, Kyle; Falzarano, Darryl; Marzi, Andrea; Fischer, Robert J.; Safronetz, David; Hoenen, Thomas; Groseth, Allison; van Doremalen, Neeltje; Bushmaker, Trenton; McNally, Kristin L.; Feldmann, Friederike; Williamson, Brandi N.; Best, Sonja M.; Ebihara, Hideki; Damiani, Igor A. C.; Adamson, Brett; Zoon, Kathryn C.; Nyenswah, Tolbert G.; Bolay, Fatorma K.; Massaquoi, Moses; Sprecher, Armand; Feldmann, Heinz; Munster, Vincent J.

2016-01-01

The development of point-of-care clinical chemistry analyzers has enabled the implementation of these ancillary tests in field laboratories in resource-limited outbreak areas. The Eternal Love Winning Africa (ELWA) outbreak diagnostic laboratory, established in Monrovia, Liberia, to provide Ebola virus and Plasmodium spp. diagnostics during the Ebola epidemic, implemented clinical chemistry analyzers in December 2014. Clinical chemistry testing was performed for 68 patients in triage, including 12 patients infected with Ebola virus and 18 infected with Plasmodium spp. The main distinguishing feature in clinical chemistry of Ebola virus–infected patients was the elevation in alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, and γ-glutamyltransferase levels and the decrease in calcium. The implementation of clinical chemistry is probably most helpful when the medical supportive care implemented at the Ebola treatment unit allows for correction of biochemistry derangements and on-site clinical chemistry analyzers can be used to monitor electrolyte balance. PMID:27471319

21 CFR 862.2140 - Centrifugal chemistry analyzer for clinical use.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Centrifugal chemistry analyzer for clinical use... SERVICES (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Laboratory Instruments § 862.2140 Centrifugal chemistry analyzer for clinical use. (a) Identification. A centrifugal...

21 CFR 862.2140 - Centrifugal chemistry analyzer for clinical use.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Centrifugal chemistry analyzer for clinical use... SERVICES (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Laboratory Instruments § 862.2140 Centrifugal chemistry analyzer for clinical use. (a) Identification. A centrifugal...

21 CFR 862.2140 - Centrifugal chemistry analyzer for clinical use.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Centrifugal chemistry analyzer for clinical use... SERVICES (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Laboratory Instruments § 862.2140 Centrifugal chemistry analyzer for clinical use. (a) Identification. A centrifugal...

21 CFR 862.2140 - Centrifugal chemistry analyzer for clinical use.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Centrifugal chemistry analyzer for clinical use... SERVICES (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Laboratory Instruments § 862.2140 Centrifugal chemistry analyzer for clinical use. (a) Identification. A centrifugal...

21 CFR 862.2140 - Centrifugal chemistry analyzer for clinical use.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Centrifugal chemistry analyzer for clinical use... SERVICES (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Laboratory Instruments § 862.2140 Centrifugal chemistry analyzer for clinical use. (a) Identification. A centrifugal...

Clinical Chemistry of Patients With Ebola in Monrovia, Liberia.

PubMed

de Wit, Emmie; Kramer, Shelby; Prescott, Joseph; Rosenke, Kyle; Falzarano, Darryl; Marzi, Andrea; Fischer, Robert J; Safronetz, David; Hoenen, Thomas; Groseth, Allison; van Doremalen, Neeltje; Bushmaker, Trenton; McNally, Kristin L; Feldmann, Friederike; Williamson, Brandi N; Best, Sonja M; Ebihara, Hideki; Damiani, Igor A C; Adamson, Brett; Zoon, Kathryn C; Nyenswah, Tolbert G; Bolay, Fatorma K; Massaquoi, Moses; Sprecher, Armand; Feldmann, Heinz; Munster, Vincent J

2016-10-15

The development of point-of-care clinical chemistry analyzers has enabled the implementation of these ancillary tests in field laboratories in resource-limited outbreak areas. The Eternal Love Winning Africa (ELWA) outbreak diagnostic laboratory, established in Monrovia, Liberia, to provide Ebola virus and Plasmodium spp. diagnostics during the Ebola epidemic, implemented clinical chemistry analyzers in December 2014. Clinical chemistry testing was performed for 68 patients in triage, including 12 patients infected with Ebola virus and 18 infected with Plasmodium spp. The main distinguishing feature in clinical chemistry of Ebola virus-infected patients was the elevation in alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, and γ-glutamyltransferase levels and the decrease in calcium. The implementation of clinical chemistry is probably most helpful when the medical supportive care implemented at the Ebola treatment unit allows for correction of biochemistry derangements and on-site clinical chemistry analyzers can be used to monitor electrolyte balance. Published by Oxford University Press for the Infectious Diseases Society of America 2016. This work is written by (a) US Government employee(s) and is in the public domain in the US.

Impact of menstruation on select hematology and clinical chemistry variables in cynomolgus macaques.

PubMed

Perigard, Christopher J; Parrula, M Cecilia M; Larkin, Matthew H; Gleason, Carol R

2016-06-01

In preclinical studies with cynomolgus macaques, it is common to have one or more females presenting with menses. Published literature indicates that the blood lost during menses causes decreases in red blood cell mass variables (RBC, HGB, and HCT), which would be a confounding factor in the interpretation of drug-related effects on clinical pathology data, but no scientific data have been published to support this claim. This investigation was conducted to determine if the amount of blood lost during menses in cynomolgus macaques has an effect on routine hematology and serum chemistry variables. Ten female cynomolgus macaques (Macaca fascicularis), 5 to 6.5 years old, were observed daily during approximately 3 months (97 days) for the presence of menses. Hematology and serum chemistry variables were evaluated twice weekly. The results indicated that menstruation affects the erythrogram including RBC, HGB, HCT, MCHC, MCV, reticulocyte count, RDW, the leukogram including neutrophil, lymphocyte, and monocyte counts, and chemistry variables, including GGT activity, and the concentrations of total proteins, albumin, globulins, and calcium. The magnitude of the effect of menstruation on susceptible variables is dependent on the duration of the menstrual phase. Macaques with menstrual phases lasting ≥ 7 days are more likely to develop changes in variables related to chronic blood loss. In preclinical toxicology studies with cynomolgus macaques, interpretation of changes in several commonly evaluated hematology and serum chemistry variables requires adequate clinical observation and documentation concerning presence and duration of menses. There is a concern that macaques with long menstrual cycles can develop iron deficiency anemia due to chronic menstrual blood loss. © 2016 American Society for Veterinary Clinical Pathology.

Clinical chemistry reference values for 75-year-old apparently healthy persons.

PubMed

Huber, Klaus Roland; Mostafaie, Nazanin; Stangl, Gerhard; Worofka, Brigitte; Kittl, Eva; Hofmann, Jörg; Hejtman, Milos; Michael, Rainer; Weissgram, Silvia; Leitha, Thomas; Jungwirth, Susanne; Fischer, Peter; Tragl, Karl-Heinz; Bauer, Kurt

2006-01-01

Clinical chemistry reference values for elderly persons are sparse and mostly intermixed with those for younger subjects. To understand the links between metabolism and aging, it is paramount to differentiate between "normal" physiological processes in apparently healthy elderly subjects and metabolic changes due to long-lasting diseases. The Vienna Transdanube Aging (VITA) study, which began in 2000 and is continuing, will allow us to do just that, because more than 600 male and female volunteers aged exactly 75 years (to exclude any influence of the "aging" factor in this cohort) are participating in this study. Extensive clinical, neurological, biochemical, psychological, genetic, and radiological analyses, with a special emphasis on consumption of medication and abuse of drugs, were performed on each of the probands. The multitude of data and questionnaires obtained made possible an a posteriori approach to select individuals fulfilling criteria for a reference sample group of apparently healthy 75-year-old subjects for our study. Specific analytes were quantified on automated clinical analyzers, while manual methods were used for hormonal analytes. All clinical chemistry analytes were evaluated using in-depth statistical analyses with SPSS for Windows. In all, reference intervals for 45 analytes could be established. These include routine parameters for the assessment of organ functions, as well as hormone concentrations and hematological appraisals. Because all patients were reevaluated after exactly 30 months in the course of this study, we had the opportunity to reassess their health status at the age of 77.5 years. This was very useful for validation of the first round data set. Data of the second round evaluation corroborate the reference limits of the baseline analysis and further confirm our inclusion and exclusion criteria. In summary, we have established a reliable set of reference data for hormonal, hematological, and clinical chemistry analytes for

21 CFR 862.2160 - Discrete photometric chemistry analyzer for clinical use.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Discrete photometric chemistry analyzer for... AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Laboratory Instruments § 862.2160 Discrete photometric chemistry analyzer for clinical use. (a...

21 CFR 862.2160 - Discrete photometric chemistry analyzer for clinical use.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Discrete photometric chemistry analyzer for... AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Laboratory Instruments § 862.2160 Discrete photometric chemistry analyzer for clinical use. (a...

21 CFR 862.2160 - Discrete photometric chemistry analyzer for clinical use.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Discrete photometric chemistry analyzer for... AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Laboratory Instruments § 862.2160 Discrete photometric chemistry analyzer for clinical use. (a...

21 CFR 862.2160 - Discrete photometric chemistry analyzer for clinical use.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Discrete photometric chemistry analyzer for... AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Laboratory Instruments § 862.2160 Discrete photometric chemistry analyzer for clinical use. (a...

Selecting automation for the clinical chemistry laboratory.

PubMed

Melanson, Stacy E F; Lindeman, Neal I; Jarolim, Petr

2007-07-01

Laboratory automation proposes to improve the quality and efficiency of laboratory operations, and may provide a solution to the quality demands and staff shortages faced by today's clinical laboratories. Several vendors offer automation systems in the United States, with both subtle and obvious differences. Arriving at a decision to automate, and the ensuing evaluation of available products, can be time-consuming and challenging. Although considerable discussion concerning the decision to automate has been published, relatively little attention has been paid to the process of evaluating and selecting automation systems. To outline a process for evaluating and selecting automation systems as a reference for laboratories contemplating laboratory automation. Our Clinical Chemistry Laboratory staff recently evaluated all major laboratory automation systems in the United States, with their respective chemistry and immunochemistry analyzers. Our experience is described and organized according to the selection process, the important considerations in clinical chemistry automation, decisions and implementation, and we give conclusions pertaining to this experience. Including the formation of a committee, workflow analysis, submitting a request for proposal, site visits, and making a final decision, the process of selecting chemistry automation took approximately 14 months. We outline important considerations in automation design, preanalytical processing, analyzer selection, postanalytical storage, and data management. Selecting clinical chemistry laboratory automation is a complex, time-consuming process. Laboratories considering laboratory automation may benefit from the concise overview and narrative and tabular suggestions provided.

Providing Relevance in Chemistry for Nursing Students

ERIC Educational Resources Information Center

Jones, Theodore H. D.

1976-01-01

Describes an introductory chemistry course for nurses in which students learn basic chemical principles by performing 12 chemical analyses that are routinely conducted on body fluids and listed on a patient's clinical laboratory chart. (MLH)

21 CFR 862.2160 - Discrete photometric chemistry analyzer for clinical use.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Discrete photometric chemistry analyzer for... Clinical Laboratory Instruments § 862.2160 Discrete photometric chemistry analyzer for clinical use. (a) Identification. A discrete photometric chemistry analyzer for clinical use is a device intended to duplicate...

Very poor agreement between routine outpatient clinic office and ambulatory blood pressure: time to improve an old hospital outpatient clinic routine?

PubMed

Reinhard, Mark; Poulsen, Per L; Christensen, Kent L

2016-12-01

We investigated the agreement between elevated outpatient clinic office blood pressure (OC-OBP) as measured in the daily routine in our University Hospital Cardiology Outpatient Clinic and subsequent awake ambulatory blood pressure (AABP). In all patients referred for ambulatory blood pressure monitoring from our Cardiology Outpatient Clinic, we identified OC-OBP and changes in medication in the period from 1 January 2014 to 15 September 2015. The AABP was used as a reference measurement for the OC-OBP. A total of 183 patients were included in the study. Their mean age was 62.1±14.0 years and 49% were women. The mean systolic OC-OBP was 166.8±17.9 mmHg and the difference between the mean systolic OC-OBP and AABP was 28.0±19.5 mmHg (P<0.001) with 95% limits of agreement from -10.2 to +66.3 mmHg. The difference in mean systolic OC-OBP and AABP was 18.6±14.7 mmHg in patients less than 45 years (n=21), 24.8±18.2 mmHg in patients 45-74 years (n=121) and 42.3±18.5 mmHg in patients more than or equal to 75 years (n=41). In 32 (17%) of the patients, the antihypertensive treatment was intensified before the AABP, but in nine (28%) of these patients, the antihypertensive treatment was reduced again after the AABP because of low blood pressure. Routine OC-OBP in a busy cardiology clinic agrees poorly with AABP and may lead to unnecessary treatment and pharmacologically induced symptomatic hypotension, particularly in elderly patients. The results of this study urgently call for alternative solutions to routine OC-OBP in hospital outpatient clinics.

Teaching Techniques in Clinical Chemistry.

ERIC Educational Resources Information Center

Wilson, Diane

This master's thesis presents several instructional methods and techniques developed for each of eleven topics or subject areas in clinical chemistry: carbohydrate metabolism, lipid metabolism, diagnostic enzymology, endocrinology, toxicology, quality control, electrolytes, acid base balance, hepatic function, nonprotein nitrogenous compounds, and…

Adult Hematology and Clinical Chemistry Laboratory Reference Ranges in a Zimbabwean Population.

PubMed

Samaneka, Wadzanai P; Mandozana, Gibson; Tinago, Willard; Nhando, Nehemiah; Mgodi, Nyaradzo M; Bwakura-Dangarembizi, Mutsawashe F; Munjoma, Marshall W; Gomo, Zvenyika A R; Chirenje, Zvavahera M; Hakim, James G

2016-01-01

Laboratory reference ranges used for clinical care and clinical trials in various laboratories in Zimbabwe were derived from textbooks and research studies conducted more than ten years ago. Periodic verification of these ranges is essential to track changes over time. The purpose of this study was to establish hematology and chemistry laboratory reference ranges using more rigorous methods. A community-based cross-sectional study was carried out in Harare, Chitungwiza, and Mutoko. A multistage sampling technique was used. Samples were transported from the field for analysis at the ISO15189 certified University of Zimbabwe-University of California San Francisco Central Research Laboratory. Hematology and clinical chemistry reference ranges lower and upper reference limits were estimated at the 2.5th and 97.5th percentiles respectively. A total of 769 adults (54% males) aged 18 to 55 years were included in the analysis. Median age was 28 [IQR: 23-35] years. Males had significantly higher red cell counts, hemoglobin, hematocrit, and mean corpuscular hemoglobin compared to females. Females had higher white cell counts, platelets, absolute neutrophil counts, and absolute lymphocyte counts compared to males. There were no gender differences in eosinophils, monocytes, and absolute basophil count. Males had significantly higher levels of urea, sodium, potassium, calcium, creatinine, amylase, total protein, albumin and liver enzymes levels compared to females. Females had higher cholesterol and lipase compared with males. There are notable differences in the white cell counts, neutrophils, cholesterol, and creatinine kinase when compared with the currently used reference ranges. Data from this study provides new country specific reference ranges which should be immediately adopted for routine clinical care and accurate monitoring of adverse events in research studies.

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.

21 CFR 862.2150 - Continuous flow sequential multiple chemistry analyzer for clinical use.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Continuous flow sequential multiple chemistry..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Laboratory Instruments § 862.2150 Continuous flow sequential multiple chemistry...

21 CFR 862.2150 - Continuous flow sequential multiple chemistry analyzer for clinical use.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Continuous flow sequential multiple chemistry..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Laboratory Instruments § 862.2150 Continuous flow sequential multiple chemistry...

21 CFR 862.2150 - Continuous flow sequential multiple chemistry analyzer for clinical use.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Continuous flow sequential multiple chemistry..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Laboratory Instruments § 862.2150 Continuous flow sequential multiple chemistry...

21 CFR 862.2150 - Continuous flow sequential multiple chemistry analyzer for clinical use.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Continuous flow sequential multiple chemistry..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Laboratory Instruments § 862.2150 Continuous flow sequential multiple chemistry...

21 CFR 862.2150 - Continuous flow sequential multiple chemistry analyzer for clinical use.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Continuous flow sequential multiple chemistry..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Laboratory Instruments § 862.2150 Continuous flow sequential multiple chemistry...

Sigma metrics used to assess analytical quality of clinical chemistry assays: importance of the allowable total error (TEa) target.

PubMed

Hens, Koen; Berth, Mario; Armbruster, Dave; Westgard, Sten

2014-07-01

Six Sigma metrics were used to assess the analytical quality of automated clinical chemistry and immunoassay tests in a large Belgian clinical laboratory and to explore the importance of the source used for estimation of the allowable total error. Clinical laboratories are continually challenged to maintain analytical quality. However, it is difficult to measure assay quality objectively and quantitatively. The Sigma metric is a single number that estimates quality based on the traditional parameters used in the clinical laboratory: allowable total error (TEa), precision and bias. In this study, Sigma metrics were calculated for 41 clinical chemistry assays for serum and urine on five ARCHITECT c16000 chemistry analyzers. Controls at two analyte concentrations were tested and Sigma metrics were calculated using three different TEa targets (Ricos biological variability, CLIA, and RiliBÄK). Sigma metrics varied with analyte concentration, the TEa target, and between/among analyzers. Sigma values identified those assays that are analytically robust and require minimal quality control rules and those that exhibit more variability and require more complex rules. The analyzer to analyzer variability was assessed on the basis of Sigma metrics. Six Sigma is a more efficient way to control quality, but the lack of TEa targets for many analytes and the sometimes inconsistent TEa targets from different sources are important variables for the interpretation and the application of Sigma metrics in a routine clinical laboratory. Sigma metrics are a valuable means of comparing the analytical quality of two or more analyzers to ensure the comparability of patient test results.

77 FR 9947 - Guidance for Industry: Early Clinical Trials With Live Biotherapeutic Products: Chemistry...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-21

...] Guidance for Industry: Early Clinical Trials With Live Biotherapeutic Products: Chemistry, Manufacturing... ``Guidance for Industry: Early Clinical Trials With Live Biotherapeutic Products: Chemistry, Manufacturing... for Industry: Early Clinical Trials With Live Biotherapeutic Products: Chemistry, Manufacturing, and...

Taking a new biomarker into routine use – A perspective from the routine clinical biochemistry laboratory

PubMed Central

Sturgeon, Catharine; Hill, Robert; Hortin, Glen L; Thompson, Douglas

2010-01-01

There is increasing pressure to provide cost-effective healthcare based on “best practice.” Consequently, new biomarkers are only likely to be introduced into routine clinical biochemistry departments if they are supported by a strong evidence base and if the results will improve patient management and outcome. This requires convincing evidence of the benefits of introducing the new test, ideally reflected in fewer hospital admissions, fewer additional investigations and/or fewer clinic visits. Carefully designed audit and cost-benefit studies in relevant patient groups must demonstrate that introducing the biomarker delivers an improved and more effective clinical pathway. From the laboratory perspective, pre-analytical requirements must be thoroughly investigated at an early stage. Good stability of the biomarker in relevant physiological matrices is essential to avoid the need for special processing. Absence of specific timing requirements for sampling and knowledge of the effect of medications that might be used to treat the patients in whom the biomarker will be measured is also highly desirable. Analytically, automation is essential in modern high-throughput clinical laboratories. Assays must therefore be robust, fulfilling standard requirements for linearity on dilution, precision and reproducibility, both within- and between-run. Provision of measurements by a limited number of specialized reference laboratories may be most appropriate, especially when a new biomarker is first introduced into routine practice. PMID:21137030

Routine pharmacogenetic testing in clinical practice: dream or reality?

PubMed

Grossman, Iris

2007-10-01

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

Continuing Education Instrumentation Training in Clinical Chemistry.

ERIC Educational Resources Information Center

LeBlanc, Jacqueline; Frankel, Saundra

1980-01-01

Describes the continuing education program for clinical chemistry instrumentation training established at The College of Staten Island, New York. A course consisting of 14 sessions is outlined and discussed. (CS)

Using Clinical Cases to Teach General Chemistry

ERIC Educational Resources Information Center

Dewprashad, Brahmadeo; Kosky, Charles; Vaz, Geraldine S.; Martin, Charlotte L.

2004-01-01

A clinical study was designed and used to show the relationship of health and medicine, in a typical clinical scenario, where many chemical principles are involved and that an integrated knowledge of chemistry and biology is essential to the understanding, diagnosing and treating of illnesses. A case study would be a positive learning experience…

Reporting unit size and measurement uncertainty: current Australian practice in clinical chemistry and haematology.

PubMed

Hawkins, Robert C; Badrick, Tony

2015-08-01

In this study we aimed to compare the reporting unit size used by Australian laboratories for routine chemistry and haematology tests to the unit size used by learned authorities and in standard laboratory textbooks and to the justified unit size based on measurement uncertainty (MU) estimates from quality assurance program data. MU was determined from Royal College of Pathologists of Australasia (RCPA) - Australasian Association of Clinical Biochemists (AACB) and RCPA Haematology Quality Assurance Program survey reports. The reporting unit size implicitly suggested in authoritative textbooks, the RCPA Manual, and the General Serum Chemistry program itself was noted. We also used published data on Australian laboratory practices.The best performing laboratories could justify their chemistry unit size for 55% of analytes while comparable figures for the 50% and 90% laboratories were 14% and 8%, respectively. Reporting unit size was justifiable for all laboratories for red cell count, >50% for haemoglobin but only the top 10% for haematocrit. Few, if any, could justify their mean cell volume (MCV) and mean cell haemoglobin concentration (MCHC) reporting unit sizes.The reporting unit size used by many laboratories is not justified by present analytical performance. Using MU estimates to determine the reporting interval for quantitative laboratory results ensures reporting practices match local analytical performance and recognises the inherent error of the measurement process.

Estimating reliable paediatric reference intervals in clinical chemistry and haematology.

PubMed

Ridefelt, Peter; Hellberg, Dan; Aldrimer, Mattias; Gustafsson, Jan

2014-01-01

Very few high-quality studies on paediatric reference intervals for general clinical chemistry and haematology 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 present review summarises current reference interval studies for common clinical chemistry and haematology analyses. ©2013 Foundation Acta Paediatrica. Published by John Wiley & Sons Ltd.

Contributions of Analytical Chemistry to the Clinical Laboratory.

ERIC Educational Resources Information Center

Skogerboe, Kristen J.

1988-01-01

Highlights several analytical techniques that are being used in state-of-the-art clinical labs. Illustrates how other advances in instrumentation may contribute to clinical chemistry in the future. Topics include: biosensors, polarization spectroscopy, chemiluminescence, fluorescence, photothermal deflection, and chromatography in clinical…

How characteristic routines of clinical departments influence students' self-regulated learning: A grounded theory study.

PubMed

Berkhout, J J; Slootweg, I A; Helmich, E; Teunissen, P W; van der Vleuten, C P M; Jaarsma, A D C

2017-11-01

In clerkships, students are expected to self-regulate their learning. How clinical departments and their routine approach on clerkships influences students' self-regulated learning (SRL) is unknown. This study explores how characteristic routines of clinical departments influence medical students' SRL. Six focus groups including 39 purposively sampled participants from one Dutch university were organized to study how characteristic routines of clinical departments influenced medical students' SRL from a constructivist paradigm, using grounded theory methodology. The focus groups were audio recorded, transcribed verbatim and were analyzed iteratively using constant comparison and open, axial and interpretive coding. Students described that clinical departments influenced their SRL through routines which affected the professional relationships they could engage in and affected their perception of a department's invested effort in them. Students' SRL in a clerkship can be supported by enabling them to engage others in their SRL and by having them feel that effort is invested in their learning. Our study gives a practical insight in how clinical departments influenced students' SRL. Clinical departments can affect students' motivation to engage in SRL, influence the variety of SRL strategies that students can use and how meaningful students perceive their SRL experiences to be.

Advance Care Planning: Understanding Clinical Routines and Experiences of Interprofessional Team Members in Diverse Health Care Settings.

PubMed

Arnett, Kelly; Sudore, Rebecca L; Nowels, David; Feng, Cindy X; Levy, Cari R; Lum, Hillary D

2017-12-01

Interprofessional health care team members consider advance care planning (ACP) to be important, yet gaps remain in systematic clinical routines to support ACP. A clearer understanding of the interprofessional team members' perspectives on ACP clinical routines in diverse settings is needed. One hundred eighteen health care team members from community-based clinics, long-term care facilities, academic clinics, federally qualified health centers, and hospitals participated in a 35-question, cross-sectional online survey to assess clinical routines, workflow processes, and policies relating to ACP. Respondents were 53% physicians, 18% advanced practice nurses, 11% nurses, and 18% other interprofessional team members including administrators, chaplains, social workers, and others. Regarding clinical routines, respondents reported that several interprofessional team members play a role in facilitating ACP (ie, physician, social worker, nurse, others). Most (62%) settings did not have, or did not know of, policies related to ACP documentation. Only 14% of settings had a patient education program. Two-thirds of the respondents said that addressing ACP is a high priority and 85% felt that nonphysicians could have ACP conversations with appropriate training. The clinical resources needed to improve clinical routines included training for providers and staff, dedicated staff to facilitate ACP, and availability of patient/family educational materials. Although interprofessional health care team members consider ACP a priority and several team members may be involved, clinical settings lack systematic clinical routines to support ACP. Patient educational materials, interprofessional team training, and policies to support ACP clinical workflows that do not rely solely on physicians could improve ACP across diverse clinical settings.

Routine clinical application of virtual reality in abdominal surgery.

PubMed

Sampogna, Gianluca; Pugliese, Raffaele; Elli, Marco; Vanzulli, Angelo; Forgione, Antonello

2017-06-01

The advantages of 3D reconstruction, immersive virtual reality (VR) and 3D printing in abdominal surgery have been enunciated for many years, but still today their application in routine clinical practice is almost nil. We investigate their feasibility, user appreciation and clinical impact. Fifteen patients undergoing pancreatic, hepatic or renal surgery were studied realizing a 3D reconstruction of target anatomy. Then, an immersive VR environment was developed to import 3D models, and some details of the 3D scene were printed. All the phases of our workflow employed open-source software and low-cost hardware, easily implementable by other surgical services. A qualitative evaluation of the three approaches was performed by 20 surgeons, who filled in a specific questionnaire regarding a clinical case for each organ considered. Preoperative surgical planning and intraoperative guidance was feasible for all patients included in the study. The vast majority of surgeons interviewed scored their quality and usefulness as very good. Despite extra time, costs and efforts necessary to implement these systems, the benefits shown by the analysis of questionnaires recommend to invest more resources to train physicians to adopt these technologies routinely, even if further and larger studies are still mandatory.

The management of clinical laboratories in Europe: a FESCC survey. Forum of the European Societies of Clinical Chemistry and Laboratory Medicine.

PubMed

de Kieviet, Wim; Blaton, Victor; Kovacs, Gabor L; Palicka, Vladimir; Pulkki, Kari

2002-03-01

The professional duties of the specialists in clinical chemistry differ from country to country in Europe. One of the main goals of the Strategic Plan of the Forum of the European Societies of Clinical Chemistry and Laboratory Medicine (FESCC; IFCC-Europe) is to promote a high scientific and professional standard in the field of clinical chemistry and laboratory medicine in Europe. This can be stimulated by the knowledge of the local conditions in each country and by striving towards a strong and harmonised position in all the European countries. In order to enhance the knowledge of the managerial situation of the specialists in clinical chemistry in Europe, FESCC launched a survey in September 2000. This survey provides information about the position of the specialists in clinical chemistry in the various disciplines in the medical laboratories and in hospitals, and about the advisory tasks and the managerial education during the post-graduate training in clinical chemistry. Of the 35 FESCC member countries 33 have participated in the survey (94%). The results show a rather heterogeneous situation in Europe caused by the local historical developments, the differences in academic background and the relative numbers of private and physicians' office laboratories. Large differences exist between the European countries in the disciplines of laboratory medicine that are headed by a specialist in clinical chemistry. In the different countries the clinical chemistry laboratories are headed by specialists in clinical chemistry in between 20% and 100% of the laboratories. The haematology, immunology, microbiology, therapeutic drug monitoring, molecular biology and haemostasis laboratories and departments of blood banking are headed by specialists in clinical chemistry in between 0% and 100% of the laboratories. The responsibilities for the various managerial tasks of the specialists in clinical chemistry show no uniformity in Europe. In the majority of the countries the

Clinical Outcome of Degenerative Mitral Regurgitation: Critical Importance of Echocardiographic Quantitative Assessment in Routine Practice.

PubMed

Antoine, Clemence; Benfari, Giovanni; Michelena, Hector I; Malouf, Joseph F; Nkomo, Vuyisile T; Thapa, Prabin; Enriquez-Sarano, Maurice

2018-05-31

Background -Echocardiographic quantitation of degenerative mitral regurgitation (DMR) is recommended whenever possible in clinical guidelines but is criticized and its scalability to routine clinical practice doubted. We hypothesized that echocardiographic DMR quantitation, performed in routine clinical practice by multiple practitioners predicts independently long-term survival, and thus is essential to DMR management. Methods -We included patients diagnosed with isolated mitral-valve-prolapse 2003-2011 and any degree of MR quantified by any physician/sonographer in routine clinical practice. Clinical/echocardiographic data acquired at diagnosis were retrieved electronically. Endpoint was mortality under medical treatment analyzed by Kaplan-Meir method and Proportional-Hazard models. Results -The cohort included 3914 patients (55% male) aged 62±17 years, with left ventricular ejection fraction (LVEF) 63±8% and routinely measured effective regurgitant orifice area (EROA) 19[0-40] mm 2 During follow-up (6.7±3.1 years) 696 patients died under medical management and 1263 underwent mitral surgery. In multivariate analysis, routinely measured EROA was associated with mortality (adjusted-hazard-ratio 1.19[1.13-1.24] p<0.0001 per-10mm 2 ) independently of LVEF and end-systolic diameter, symptoms and age/comorbidities. The association between routinely measured EROA and mortality persisted with competitive risk modeling (adjusted hazard-ratio 1.15[1.10-1.20] per 10mm 2 p<0.0001), or in patients without guideline-based Class I/II surgical triggers (adjusted hazard ratio 1.19[1.10-1.28] per 10mm 2 p<0.0001) and in all subgroups examined (all p<0.01). Spline curve analysis showed that, compared with general population mortality, excess mortality appears for moderate DMR (EROA ≥20mm 2 ) becomes notable ≥EROA 30mm 2 and steadily increases with higher EROA levels, > 40 mm 2 threshold. Conclusions -Echocardiographic DMR quantitation is scalable to routine practice and is

Experience of domestic violence routine screening in Family Planning NSW clinics.

PubMed

Hunter, Tara; Botfield, Jessica R; Estoesta, Jane; Markham, Pippa; Robertson, Sarah; McGeechan, Kevin

2017-04-01

This study reviewed implementation of the Domestic Violence Routine Screening (DVRS) program at Family Planning NSW and outcomes of screening to determine the feasibility of routine screening in a family planning setting and the suitability of this program in the context of women's reproductive and sexual health. A retrospective review of medical records was undertaken of eligible women attending Family Planning NSW clinics between 1 January and 31 December 2015. Modified Poisson regression was used to estimate prevalence ratios and assess association between binary outcomes and client characteristics. Of 13440 eligible women, 5491 were screened (41%). Number of visits, clinic attended, age, employment status and disability were associated with completion of screening. In all, 220 women (4.0%) disclosed domestic violence. Factors associated with disclosure were clinic attended, age group, region of birth, employment status, education and disability. Women who disclosed domestic violence were more likely to have discussed issues related to sexually transmissible infections in their consultation. All women who disclosed were assessed for any safety concerns and offered a range of suitable referral options. Although routine screening may not be appropriate in all health settings, given associations between domestic violence and sexual and reproductive health, a DVRS program is considered appropriate in sexual and reproductive health clinics and appears to be feasible in a service such as Family Planning NSW. Consistent implementation of the program should continue at Family Planning NSW and be expanded to other family planning services in Australia to support identification and early intervention for women affected by domestic violence.

Attitudes and Beliefs of Pathology Residents Regarding the Subspecialty of Clinical Chemistry: Results of a Survey.

PubMed

Haidari, Mehran; Yared, Marwan; Olano, Juan P; Alexander, C Bruce; Powell, Suzanne Z

2017-02-01

-Previous studies suggest that training in pathology residency programs does not adequately prepare pathology residents to become competent in clinical chemistry. -To define the beliefs of pathology residents in the United States regarding their preparation for practicing clinical chemistry in their career, their attitude toward the discipline, and the attractiveness of clinical chemistry as a career. -The residents of all pathology residency programs in the United States were given the opportunity to participate in an online survey. -Three hundred thirty-six pathology residents responded to the survey. Analysis of the survey results indicates that pathology residents are more likely to believe that their income may be lower if they select a career that has a clinical chemistry focus and that their faculty do not value clinical chemistry as much as the anatomic pathology part of the residency. Residents also report that clinical chemistry is not as enjoyable as anatomic pathology rotations during residency or preferable as a sole career path. A large proportion of residents also believe that they will be slightly prepared or not prepared to practice clinical chemistry by the end of their residency and that they do not have enough background and/or time to learn clinical chemistry during their residency programs to be able to practice this specialty effectively post graduation. -Our survey results suggest that many pathology residents do not have a positive attitude toward clinical chemistry and do not experience a supportive learning environment with an expectation that they will become competent in clinical chemistry with a residency alone.

42 CFR 493.839 - Condition: Chemistry.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 5 2010-10-01 2010-10-01 false Condition: Chemistry. 493.839 Section 493.839... These Tests § 493.839 Condition: Chemistry. The specialty of chemistry includes for the purposes of proficiency testing the subspecialties of routine chemistry, endocrinology, and toxicology. ...

42 CFR 493.839 - Condition: Chemistry.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 42 Public Health 5 2014-10-01 2014-10-01 false Condition: Chemistry. 493.839 Section 493.839... These Tests § 493.839 Condition: Chemistry. The specialty of chemistry includes for the purposes of proficiency testing the subspecialties of routine chemistry, endocrinology, and toxicology. ...

42 CFR 493.839 - Condition: Chemistry.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 42 Public Health 5 2013-10-01 2013-10-01 false Condition: Chemistry. 493.839 Section 493.839... These Tests § 493.839 Condition: Chemistry. The specialty of chemistry includes for the purposes of proficiency testing the subspecialties of routine chemistry, endocrinology, and toxicology. ...

42 CFR 493.839 - Condition: Chemistry.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 5 2011-10-01 2011-10-01 false Condition: Chemistry. 493.839 Section 493.839... These Tests § 493.839 Condition: Chemistry. The specialty of chemistry includes for the purposes of proficiency testing the subspecialties of routine chemistry, endocrinology, and toxicology. ...

42 CFR 493.839 - Condition: Chemistry.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 42 Public Health 5 2012-10-01 2012-10-01 false Condition: Chemistry. 493.839 Section 493.839... These Tests § 493.839 Condition: Chemistry. The specialty of chemistry includes for the purposes of proficiency testing the subspecialties of routine chemistry, endocrinology, and toxicology. ...

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.

National Cancer Institute and American Association for Clinical Chemistry Partner to Bridge the Gap | Office of Cancer Clinical Proteomics Research

Cancer.gov

The National Cancer Institute, through its Clinical Proteomic Technologies for Cancer (CPTC) initiative has entered into a memorandum of understanding with the American Association for Clinical Chemistry (AACC) to join forces to promote and educate the clinical chemistry community in the area of proteomic standards and technology advances.

42 CFR 493.929 - Chemistry.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 5 2010-10-01 2010-10-01 false Chemistry. 493.929 Section 493.929 Public Health... Proficiency Testing Programs by Specialty and Subspecialty § 493.929 Chemistry. The subspecialties under the specialty of chemistry for which a proficiency testing program may offer proficiency testing are routine...

42 CFR 493.929 - Chemistry.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 42 Public Health 5 2012-10-01 2012-10-01 false Chemistry. 493.929 Section 493.929 Public Health... Proficiency Testing Programs by Specialty and Subspecialty § 493.929 Chemistry. The subspecialties under the specialty of chemistry for which a proficiency testing program may offer proficiency testing are routine...

42 CFR 493.929 - Chemistry.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 42 Public Health 5 2014-10-01 2014-10-01 false Chemistry. 493.929 Section 493.929 Public Health... Proficiency Testing Programs by Specialty and Subspecialty § 493.929 Chemistry. The subspecialties under the specialty of chemistry for which a proficiency testing program may offer proficiency testing are routine...

42 CFR 493.929 - Chemistry.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 42 Public Health 5 2013-10-01 2013-10-01 false Chemistry. 493.929 Section 493.929 Public Health... Proficiency Testing Programs by Specialty and Subspecialty § 493.929 Chemistry. The subspecialties under the specialty of chemistry for which a proficiency testing program may offer proficiency testing are routine...

42 CFR 493.929 - Chemistry.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 5 2011-10-01 2011-10-01 false Chemistry. 493.929 Section 493.929 Public Health... Proficiency Testing Programs by Specialty and Subspecialty § 493.929 Chemistry. The subspecialties under the specialty of chemistry for which a proficiency testing program may offer proficiency testing are routine...

SPIRIT: Systematic Planning of Intelligent Reuse of Integrated Clinical Routine Data. A Conceptual Best-practice Framework and Procedure Model.

PubMed

Hackl, W O; Ammenwerth, E

2016-01-01

Secondary use of clinical routine data is receiving an increasing amount of attention in biomedicine and healthcare. However, building and analysing integrated clinical routine data repositories are nontrivial, challenging tasks. As in most evolving fields, recognized standards, well-proven methodological frameworks, or accurately described best-practice approaches for the systematic planning of solutions for secondary use of routine medical record data are missing. We propose a conceptual best-practice framework and procedure model for the systematic planning of intelligent reuse of integrated clinical routine data (SPIRIT). SPIRIT was developed based on a broad literature overview and further refined in two case studies with different kinds of clinical routine data, including process-oriented nursing data from a large hospital group and high-volume multimodal clinical data from a neurologic intensive care unit. SPIRIT aims at tailoring secondary use solutions to specific needs of single departments without losing sight of the institution as a whole. It provides a general conceptual best-practice framework consisting of three parts: First, a secondary use strategy for the whole organization is determined. Second, comprehensive analyses are conducted from two different viewpoints to define the requirements regarding a clinical routine data reuse solution at the system level from the data perspective (BOTTOM UP) and at the strategic level from the future users perspective (TOP DOWN). An obligatory clinical context analysis (IN BETWEEN) facilitates refinement, combination, and integration of the different requirements. The third part of SPIRIT is dedicated to implementation, which comprises design and realization of clinical data integration and management as well as data analysis solutions. The SPIRIT framework is intended to be used to systematically plan the intelligent reuse of clinical routine data for multiple purposes, which often was not intended when the

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

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

Clinical chemistry since 1800: growth and development.

PubMed

Rosenfeld, Louis

2002-01-01

The 19th and 20th centuries witnessed the growth and development of clinical chemistry. Many of the individuals and the significance of their contributions are not very well known, especially to new members of the profession. This survey should help familiarize them with the names and significance of the contributions of physicians and chemists such as Fourcroy, Berzelius, Liebig, Prout, Bright, and Rees. Folin and Van Slyke are better known, and it was their work near the end of the second decade of the 20th century that brought the clinical chemist out of the annex of the mortuary and into close relationship with the patient at the bedside. However, the impact on clinical chemistry and the practice of medicine by the 1910 exposé written by Abraham Flexner is not as well known as it deserves to be, nor is the impetus that World War I gave to the spread of laboratory medicine generally known. In the closing decades of the 20th century, automated devices produced an overabundance, and an overuse and misuse, of testing to the detriment of careful history taking and bedside examination of the patient. This is attributable in part to a fascination with machine-produced data. There was also an increased awareness of the value of chemical methods of diagnosis and the need to bring clinician and clinical chemist into a closer partnership. Clinical chemists were urged to develop services into dynamic descriptions of the diagnostic values of laboratory results and to identify medical relevance in interpreting significance for the clinician.

The quality of clinical maternal and neonatal healthcare - a strategy for identifying 'routine care signal functions'.

PubMed

Brenner, Stephan; De Allegri, Manuela; Gabrysch, Sabine; Chinkhumba, Jobiba; Sarker, Malabika; Muula, Adamson S

2015-01-01

A variety of clinical process indicators exists to measure the quality of care provided by maternal and neonatal health (MNH) programs. To allow comparison across MNH programs in low- and middle-income countries (LMICs), a core set of essential process indicators is needed. Although such a core set is available for emergency obstetric care (EmOC), the 'EmOC signal functions', a similar approach is currently missing for MNH routine care evaluation. We describe a strategy for identifying core process indicators for routine care and illustrate their usefulness in a field example. We first developed an indicator selection strategy by combining epidemiological and programmatic aspects relevant to MNH in LMICs. We then identified routine care process indicators meeting our selection criteria by reviewing existing quality of care assessment protocols. We grouped these indicators into three categories based on their main function in addressing risk factors of maternal or neonatal complications. We then tested this indicator set in a study assessing MNH quality of clinical care in 33 health facilities in Malawi. Our strategy identified 51 routine care processes: 23 related to initial patient risk assessment, 17 to risk monitoring, 11 to risk prevention. During the clinical performance assessment a total of 82 cases were observed. Birth attendants' adherence to clinical standards was lowest in relation to risk monitoring processes. In relation to major complications, routine care processes addressing fetal and newborn distress were performed relatively consistently, but there were major gaps in the performance of routine care processes addressing bleeding, infection, and pre-eclampsia risks. The identified set of process indicators could identify major gaps in the quality of obstetric and neonatal care provided during the intra- and immediate postpartum period. We hope our suggested indicators for essential routine care processes will contribute to streamlining MNH program

The effect of extremely high glucose concentrations on 21 routine chemistry and thyroid Abbott assays: interference study.

PubMed

Çuhadar, Serap; Köseoğlu, Mehmet; Çinpolat, Yasemin; Buğdaycı, Güler; Usta, Murat; Semerci, Tuna

2016-01-01

Extremely high glucose concentrations have been shown to interfere with creatinine assays especially with Jaffe method in peritoneal dialysate. Because diabetes is the fastest growing chronic disease in the world, laboratories study with varying glucose concentrations. We investigated whether different levels of glucose spiked in serum interfere with 21 routine chemistry and thyroid assays at glucose concentrations between 17-51 mmol/L. Baseline (group I) serum pool with glucose concentration of 5.55 (5.44-5.61) mmol/L was prepared from patient sera. Spiking with 20% dextrose solution, sample groups were obtained with glucose concentrations: 17.09, 34.52, and 50.95 mmol/L (group II, III, IV, respectively). Total of 21 biochemistry analytes and thyroid tests were studied on Abbott c8000 and i2000sr with commercial reagents. Bias from baseline value was checked statistically and clinically. Creatinine increased significantly by 8.74%, 31.66%, 55.31% at groups II, III, IV, respectively with P values of < 0.001. At the median glucose concentration of 50.95 mmol/L, calcium, albumin, chloride and FT4 biased significantly clinically (-0.85%, 1.63%, 0.65%, 7.4% with P values 0.138, 0.214, 0.004, < 0.001, respectively). Remaining assays were free of interference. Among the numerous biochemical parameters studied, only a few parameters are affected by dramatically increased glucose concentration. The creatinine measurements obtained in human sera with the Jaffe alkaline method at high glucose concentrations should be interpreted with caution. Other tests that were affected with extremely high glucose concentrations were calcium, albumin, chloride and FT4, hence results should be taken into consideration in patients with poor diabetic control.

Utility of routine psychological screening in the childhood cancer survivor clinic.

PubMed

Recklitis, Christopher; O'Leary, Tara; Diller, Lisa

2003-03-01

This study examined the utility of routine psychologic screening in a childhood cancer survivor clinic by evaluating patient acceptance, comparing subjects' symptoms to normative data, examining the utility of specific tests, and identifying risk factors associated with psychological distress. During their annual clinic visit, 101 adult survivors of childhood cancer (median age, 25 years) completed the Symptom Checklist 90 Revised (SCL-90), as well as the Short Form 36 (SF-36), Beck Depression Inventory (BDI), and one additional suicide question. Psychological distress was operationally defined according to the published SCL-90 clinical case rule, classifying subjects with a consistent pattern of symptom elevations as clinical cases. The majority of subjects (80%) completed the screening in less than 30 minutes and reported little (15%) or no (84%) distress. Sixty-four percent believed it would help "very much" or "moderately" in getting to know them, and 35% thought it would help "slightly." On the SCL-90, 32 subjects (31.7%) had a positive screen, indicating significant psychological distress. All subjects with clinically significant symptoms on the BDI and SF-36 Mental Health Scale were cases on the SCL-90 (case-positive). Suicidal symptoms were reported in 13.9% of the sample, all of whom were SCL-90 cases. In a logistic regression model, subjects' dissatisfaction with physical appearance, poor physical health, and treatment with cranial radiation were associated with psychological distress. Results demonstrate that routine psychological screening can be successfully integrated into the cancer survivor clinic and may be effective in identifying those survivors with significant distress who require further evaluation.

Dose Adjustment for Normal Eating (DAFNE) in routine clinical practice: who benefits?

PubMed

Keen, A J A; Duncan, E; McKillop-Smith, A; Evans, N D; Gold, A E

2012-05-01

To explore the effectiveness of Dose Adjustment for Normal Eating in routine clinical practice in the UK. Participants were 124 adults with Type 1 diabetes who had completed a Dose Adjustment for Normal Eating course. Data were collected before the course and again 1 year later on a variety of biological, psychological and social measures. There were a range of significant benefits consistent with Dose Adjustment for Normal Eating aims, including: better control among those with baseline HbA(1c) ≥ 81 mmol/mol (9.6%) (z = -2.8, P = 0.004); reduced number of participants reporting severe hypoglycaemia (χ² = 4.27, P = 0.039); total eradication of diabetic ketoacidosis (χ² = 4.17, P = 0.041) and lower diabetes-related distress (z = -4.5, P < 0.001). The most deprived of the clinic population were significantly under-represented (χ² = 17.8, P = 0.001) and the levels of clinical depression were unusually low. These results indicate that Dose Adjustment for Normal Eating delivered in routine clinical practice is associated with a range of benefits and that certain clinical and psychosocial characteristics are associated with better outcomes. © 2011 The Authors. Diabetic Medicine © 2011 Diabetes UK.

Efficient linear algebra routines for symmetric matrices stored in packed form.

PubMed

Ahlrichs, Reinhart; Tsereteli, Kakha

2002-01-30

Quantum chemistry methods require various linear algebra routines for symmetric matrices, for example, diagonalization or Cholesky decomposition for positive matrices. We present a small set of these basic routines that are efficient and minimize memory requirements.

50th anniversary of Clinical Chemistry and Laboratory Medicine--a historical overview.

PubMed

Körber, Friedrich; Plebani, Mario

2013-01-01

In the early 1960s, Joachim Brugsch, one of the founders of Clinical Chemistry and Laboratory Medicine (CCLM) (then Zeitschrift für Klinische Chemie), had the idea to found a journal in the upcoming field of clinical chemistry. He approached Ernst Schütte, who was associated with the De Gruyter publishing house through another journal, to participate, and Schütte thus became the second founder of this Journal. The aim was to create a vehicle allowing the experts to express their opinions and raise their voices more clearly than they could in a journal that publishes only original experimental papers, a laborious and difficult, but important endeavor, as the profession of clinical chemistry was still in the early stages of development at this time. The first issue of this Journal was published in early 1963, and today, we are proud to celebrate the 50th anniversary of CCLM. This review describes the development of this Journal in light of the political situation of the time when it was founded, the situation of the publisher Walter De Gruyter after the erection of the Berlin Wall, and the development of clinical chemistry, and later on, laboratory medicine as a well-acknowledged discipline and profession.

Adiponectin as a routine clinical biomarker.

PubMed

Kishida, Ken; Funahashi, Tohru; Shimomura, Iichiro

2014-01-01

Adiponectin is a protein synthesized and secreted predominantly by adipocytes into the peripheral blood. However, circulating adiponectin level is inversely related with body weight, especially visceral fat accumulation. The mechanism of this paradoxical relation remains obscure. Low circulating adiponectin concentrations (hypoadiponectinemia; <4 μg/mL) are associated with a variety of diseases, including dysmetabolism (type 2 diabetes, insulin resistance, hypertension, dyslipidemia, metabolic syndrome, hyperuricemia), atherosclerosis (coronary artery disease, stroke, peripheral artery disease), sleep apnea, non-alcoholic fatty liver disease, gastritis and gastro-esophageal reflux disease, inflammatory bowel diseases, pancreatitis, osteoporosis, and cancer (endometrial cancer, postmenopausal breast cancer, leukemia, colon cancer, gastric cancer, prostate cancer). On the other hand, hyperadiponectinemia is associated with cardiac, renal and pulmonary diseases. This review article focuses on the significance of adiponectin as a clinical biomarker of obesity-related diseases. Routine measurement of adiponectin in patients with lifestyle-related diseases is highly recommended. Copyright © 2013 Elsevier Ltd. All rights reserved.

78 FR 19717 - Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-02

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee: Notice of Change of Meeting Schedule AGENCY: Food and Drug Administration, HHS. ACTION: Notice; correction...

Semantic Technologies for Re-Use of Clinical Routine Data.

PubMed

Kreuzthaler, Markus; Martínez-Costa, Catalina; Kaiser, Peter; Schulz, Stefan

2017-01-01

Routine patient data in electronic patient records are only partly structured, and an even smaller segment is coded, mainly for administrative purposes. Large parts are only available as free text. Transforming this content into a structured and semantically explicit form is a prerequisite for querying and information extraction. The core of the system architecture presented in this paper is based on SAP HANA in-memory database technology using the SAP Connected Health platform for data integration as well as for clinical data warehousing. A natural language processing pipeline analyses unstructured content and maps it to a standardized vocabulary within a well-defined information model. The resulting semantically standardized patient profiles are used for a broad range of clinical and research application scenarios.

Non-invasive prenatal testing (NIPT): Europe's first multicenter post-market clinical follow-up study validating the quality in clinical routine.

PubMed

Flöck, Anne; Tu, Ngoc-Chi; Rüland, Anna; Holzgreve, Wolfgang; Gembruch, Ulrich; Geipel, Annegret

2017-11-01

Non-invasive prenatal tests (NIPT) for the determination of fetal aneuploidies from maternal blood are firmly established in clinical routine. For the first time, the accuracy of an NIPT for the determination of trisomies 21, 18 and 13 in singleton pregnancies was assessed by means of a prospective German-wide multicenter post-market clinical follow-up study, to reliably evaluate the quality in clinical routine. The study covered the indications for testing, the test results, the rate of invasive diagnostics and the pregnancy outcome. 2232 cases were tested for trisomy 21. Of these, 1946 cases were additionally examined for trisomy 18 and 13. Sensitivity and specificity for trisomy 21 (43/43) and for trisomy 13 (2/2) were 100%, for trisomy 18 the sensitivity was 80% (4/5) with a specificity of 99.8%. Three false-positive results for trisomy 18 were observed (FPR 0.15%). The no-call rate was 0.5%. In this subgroup, 27.3% (3/11) aneuploidies were diagnosed. The rate of invasive procedures was 2.6%. NIPT provides a very high quality for the fetal trisomies 21, 13 and 18 in clinical routine. The results support the recommendation that NIPT should be offered after genetic counseling and only in conjunction with a qualified ultrasound examination.

Clinical protein mass spectrometry.

PubMed

Scherl, Alexander

2015-06-15

Quantitative protein analysis is routinely performed in clinical chemistry laboratories for diagnosis, therapeutic monitoring, and prognosis. Today, protein assays are mostly performed either with non-specific detection methods or immunoassays. Mass spectrometry (MS) is a very specific analytical method potentially very well suited for clinical laboratories. Its unique advantage relies in the high specificity of the detection. Any protein sequence variant, the presence of a post-translational modification or degradation will differ in mass and structure, and these differences will appear in the mass spectrum of the protein. On the other hand, protein MS is a relatively young technique, demanding specialized personnel and expensive instrumentation. Many scientists and opinion leaders predict MS to replace immunoassays for routine protein analysis, but there are only few protein MS applications routinely used in clinical chemistry laboratories today. The present review consists of a didactical introduction summarizing the pros and cons of MS assays compared to immunoassays, the different instrumentations, and various MS protein assays that have been proposed and/or are used in clinical laboratories. An important distinction is made between full length protein analysis (top-down method) and peptide analysis after enzymatic digestion of the proteins (bottom-up method) and its implication for the protein assay. The document ends with an outlook on what type of analyses could be used in the future, and for what type of applications MS has a clear advantage compared to immunoassays. Copyright © 2015 Elsevier Inc. All rights reserved.

First two-reagent vitamin D assay for general clinical chemistry.

PubMed

Saida, Fakhri B; Padilla-Chee, Mario; Dou, Chao; Yuan, Chong

2018-05-01

Vitamin D is a lipid-soluble molecule that plays key physiological roles in the metabolism of calcium, phosphate and magnesium. Recent studies show that deficiency in vitamin D is linked to cardiovascular diseases, autoimmune diseases and cancer. As a result, regular monitoring of 25-OH vitamin D (the main circulating form of vitamin D) is becoming essential. Current 25-OH vitamin D testing methodologies are cumbersome (too many reagents, long incubation times, phase separation) and are not compatible with general clinical chemistry platforms. Here, we report on a novel method to detect 25-OH vitamin D that is fast (results in 10 min or less), simple (two reagents) and compatible with virtually all general clinical chemistry analyzers. An immunoturbidimetric assay for 25-OH vitamin D (the Diazyme EZ Vitamin D Assay) has been developed using nanoparticles and vitamin D-specific antibodies. The performance of the assay kit, which consists of two reagents and five calibrators, was tested on the Beckman AU680 analyzer (AU680). The new assay was precise, sensitive (LOD = 7.2 nmol/L), linear (up to 390.1 nmol/L) and correlated strongly (R 2  > 0.95) with major commercial 25-OH vitamin D assays. Additionally, the assay was found to be the fastest to date, with the first results obtained within 10 min. Throughput on the AU680 was estimated at over 300 tests per hour. The newly developed 25-OH vitamin D assay is fast, precise and accurate. It can be run on most general chemistry analyzers. This assay aims at providing vitamin D-testing capabilities to all clinical chemistry laboratories. Copyright © 2018 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

Pretreatment data is highly predictive of liver chemistry signals in clinical trials.

PubMed

Cai, Zhaohui; Bresell, Anders; Steinberg, Mark H; Silberg, Debra G; Furlong, Stephen T

2012-01-01

The goal of this retrospective analysis was to assess how well predictive models could determine which patients would develop liver chemistry signals during clinical trials based on their pretreatment (baseline) information. Based on data from 24 late-stage clinical trials, classification models were developed to predict liver chemistry outcomes using baseline information, which included demographics, medical history, concomitant medications, and baseline laboratory results. Predictive models using baseline data predicted which patients would develop liver signals during the trials with average validation accuracy around 80%. Baseline levels of individual liver chemistry tests were most important for predicting their own elevations during the trials. High bilirubin levels at baseline were not uncommon and were associated with a high risk of developing biochemical Hy's law cases. Baseline γ-glutamyltransferase (GGT) level appeared to have some predictive value, but did not increase predictability beyond using established liver chemistry tests. It is possible to predict which patients are at a higher risk of developing liver chemistry signals using pretreatment (baseline) data. Derived knowledge from such predictions may allow proactive and targeted risk management, and the type of analysis described here could help determine whether new biomarkers offer improved performance over established ones.

Hepatitis B Virus Genotyping: Is the Time Ripe for Routine Clinical Use?

PubMed Central

Madan, Kaushal; Tyagi, Pankaj

2012-01-01

Hepatitis B is one of the major causes of end-stage liver disease and liver cancer worldwide. A number of host and viral factors influence the disease course and outcomes. One such viral factor is hepatitis B virus (HBV) genotypes. There are eight major HBV genotypes described from various geographic regions of the world. Although direct sequencing appears to be the gold standard for HBV genotyping, it is expensive and laborintensive and therefore cannot be applied for routine clinical use. The newer molecular methods including serotyping have made genotyping easier and simple to apply to large number of samples rapidly. The data collected mainly over the last decade have suggested that HBV genotypes may have a bearing over the natural course of the disease and its response to therapy. This review summarizes the available literature and highlights how genotyping could be incorporated into routine clinical practice in order to improve delivery of care to HBV-infected individuals. PMID:25755425

75 FR 63188 - Draft Guidance for Industry: Early Clinical Trials With Live Biotherapeutic Products: Chemistry...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-14

...] Draft Guidance for Industry: Early Clinical Trials With Live Biotherapeutic Products: Chemistry...: Chemistry, Manufacturing, and Control Information'' dated September 2010. The draft guidance provides... Products: Chemistry, Manufacturing, and Control Information'' dated September 2010. The draft guidance...

A retrospective review of performance and utility of routine clinical pelvimetry.

PubMed

Blackadar, Charles S; Viera, Anthony J

2004-01-01

Some authorities have questioned the utility of performing clinical pelvimetry as part of routine prenatal care. This study determined the frequency with which clinical pelvimetry is still performed at two military hospitals and whether the results of pelvimetry influence the management of labor and delivery. We conducted a retrospective review of prenatal records at two military hospitals. One was an overseas hospital, and one was a family medicine teaching hospital in the United States. The records of 660 pregnant women were reviewed to identify documentation that pelvimetry was performed during prenatal care and whether there was evidence that the physician managing labor and delivery altered management based on pelvimetry results. Seventy percent (461) of the 660 records reviewed had all pelvimetry measurements documented as normal, or the provider had written "good for TOL (trial of labor)," "proven to XX pounds," or similar annotation that pelvimetry was normal. Nine percent (58 records) had no documentation of pelvimetry (pelvimetry section left blank). The remaining 21% (141 charts) had at least one pelvimetry measurement listed as abnormal on the initial prenatal exam. No admission note, progress note, or operative note recorded during labor and delivery made reference to clinical pelvimetry results. No abnormal pelvimetry result was referenced in follow-up visits or appeared to make any difference in mode of delivery or treatment in labor. Two women (one at each institution) had initial visit notes indicating the need to consider radiographic pelvimetry based on the results of clinical exam, but this test was not done in either case, and both women delivered vaginally. Our study indicates that clinical pelvimetry does not change management of pregnant patients. Current practice is to allow all women a trial of labor regardless of pelvimetry results. This makes the routine performance and recording of clinical pelvimetry a waste of time, a potential

Rapid targeted somatic mutation analysis of solid tumors in routine clinical diagnostics.

PubMed

Magliacane, Gilda; Grassini, Greta; Bartocci, Paola; Francaviglia, Ilaria; Dal Cin, Elena; Barbieri, Gianluca; Arrigoni, Gianluigi; Pecciarini, Lorenza; Doglioni, Claudio; Cangi, Maria Giulia

2015-10-13

Tumor genotyping is an essential step in routine clinical practice and pathology laboratories face a major challenge in being able to provide rapid, sensitive and updated molecular tests. We developed a novel mass spectrometry multiplexed genotyping platform named PentaPanel to concurrently assess single nucleotide polymorphisms in 56 hotspots of the 5 most clinically relevant cancer genes, KRAS, NRAS, BRAF, EGFR and PIK3CA for a total of 221 detectable mutations. To both evaluate and validate the PentaPanel performance, we investigated 1025 tumor specimens of 6 different cancer types (carcinomas of colon, lung, breast, pancreas, and biliary tract, and melanomas), systematically addressing sensitivity, specificity, and reproducibility of our platform. Sanger sequencing was also performed for all the study samples. Our data showed that PentaPanel is a high throughput and robust tool, allowing genotyping for targeted therapy selection of 10 patients in the same run, with a practical turnaround time of 2 working days. Importantly, it was successfully used to interrogate different DNAs isolated from routinely processed specimens (formalin-fixed paraffin embedded, frozen, and cytological samples), covering all the requirements of clinical tests. In conclusion, the PentaPanel platform can provide an immediate, accurate and cost effective multiplex approach for clinically relevant gene mutation analysis in many solid tumors and its utility across many diseases can be particularly relevant in multiple clinical trials, including the new basket trial approach, aiming to identify appropriate targeted drug combination strategies.

Performance specifications and six sigma theory: Clinical chemistry and industry compared.

PubMed

Oosterhuis, W P; Severens, M J M J

2018-04-11

Analytical performance specifications are crucial in test development and quality control. Although consensus has been reached on the use of biological variation to derive these specifications, no consensus has been reached which model should be preferred. The Six Sigma concept is widely applied in industry for quality specifications of products and can well be compared with Six Sigma models in clinical chemistry. However, the models for measurement specifications differ considerably between both fields: where the sigma metric is used in clinical chemistry, in industry the Number of Distinct Categories is used instead. In this study the models in both fields are compared and discussed. Copyright © 2018. Published by Elsevier Inc.

Pretreatment data is highly predictive of liver chemistry signals in clinical trials

PubMed Central

Cai, Zhaohui; Bresell, Anders; Steinberg, Mark H; Silberg, Debra G; Furlong, Stephen T

2012-01-01

Purpose The goal of this retrospective analysis was to assess how well predictive models could determine which patients would develop liver chemistry signals during clinical trials based on their pretreatment (baseline) information. Patients and methods Based on data from 24 late-stage clinical trials, classification models were developed to predict liver chemistry outcomes using baseline information, which included demographics, medical history, concomitant medications, and baseline laboratory results. Results Predictive models using baseline data predicted which patients would develop liver signals during the trials with average validation accuracy around 80%. Baseline levels of individual liver chemistry tests were most important for predicting their own elevations during the trials. High bilirubin levels at baseline were not uncommon and were associated with a high risk of developing biochemical Hy’s law cases. Baseline γ-glutamyltransferase (GGT) level appeared to have some predictive value, but did not increase predictability beyond using established liver chemistry tests. Conclusion It is possible to predict which patients are at a higher risk of developing liver chemistry signals using pretreatment (baseline) data. Derived knowledge from such predictions may allow proactive and targeted risk management, and the type of analysis described here could help determine whether new biomarkers offer improved performance over established ones. PMID:23226004

Corrections of clinical chemistry test results in a laboratory information system.

PubMed

Wang, Sihe; Ho, Virginia

2004-08-01

The recently released reports by the Institute of Medicine, To Err Is Human and Patient Safety, have received national attention because of their focus on the problem of medical errors. Although a small number of studies have reported on errors in general clinical laboratories, there are, to our knowledge, no reported studies that focus on errors in pediatric clinical laboratory testing. To characterize the errors that have caused corrections to have to be made in pediatric clinical chemistry results in the laboratory information system, Misys. To provide initial data on the errors detected in pediatric clinical chemistry laboratories in order to improve patient safety in pediatric health care. All clinical chemistry staff members were informed of the study and were requested to report in writing when a correction was made in the laboratory information system, Misys. Errors were detected either by the clinicians (the results did not fit the patients' clinical conditions) or by the laboratory technologists (the results were double-checked, and the worksheets were carefully examined twice a day). No incident that was discovered before or during the final validation was included. On each Monday of the study, we generated a report from Misys that listed all of the corrections made during the previous week. We then categorized the corrections according to the types and stages of the incidents that led to the corrections. A total of 187 incidents were detected during the 10-month study, representing a 0.26% error detection rate per requisition. The distribution of the detected incidents included 31 (17%) preanalytic incidents, 46 (25%) analytic incidents, and 110 (59%) postanalytic incidents. The errors related to noninterfaced tests accounted for 50% of the total incidents and for 37% of the affected tests and orderable panels, while the noninterfaced tests and panels accounted for 17% of the total test volume in our laboratory. This pilot study provided the rate and

The Quality of Clinical Maternal and Neonatal Healthcare – A Strategy for Identifying ‘Routine Care Signal Functions’

PubMed Central

Brenner, Stephan; De Allegri, Manuela; Gabrysch, Sabine; Chinkhumba, Jobiba; Sarker, Malabika; Muula, Adamson S.

2015-01-01

Background A variety of clinical process indicators exists to measure the quality of care provided by maternal and neonatal health (MNH) programs. To allow comparison across MNH programs in low- and middle-income countries (LMICs), a core set of essential process indicators is needed. Although such a core set is available for emergency obstetric care (EmOC), the ‘EmOC signal functions’, a similar approach is currently missing for MNH routine care evaluation. We describe a strategy for identifying core process indicators for routine care and illustrate their usefulness in a field example. Methods We first developed an indicator selection strategy by combining epidemiological and programmatic aspects relevant to MNH in LMICs. We then identified routine care process indicators meeting our selection criteria by reviewing existing quality of care assessment protocols. We grouped these indicators into three categories based on their main function in addressing risk factors of maternal or neonatal complications. We then tested this indicator set in a study assessing MNH quality of clinical care in 33 health facilities in Malawi. Results Our strategy identified 51 routine care processes: 23 related to initial patient risk assessment, 17 to risk monitoring, 11 to risk prevention. During the clinical performance assessment a total of 82 cases were observed. Birth attendants’ adherence to clinical standards was lowest in relation to risk monitoring processes. In relation to major complications, routine care processes addressing fetal and newborn distress were performed relatively consistently, but there were major gaps in the performance of routine care processes addressing bleeding, infection, and pre-eclampsia risks. Conclusion The identified set of process indicators could identify major gaps in the quality of obstetric and neonatal care provided during the intra- and immediate postpartum period. We hope our suggested indicators for essential routine care processes

Routine clinical heart examinations using SQUID magnetocardiography at University of Tsukuba Hospital

NASA Astrophysics Data System (ADS)

Inaba, T.; Nakazawa, Y.; Yoshida, K.; Kato, Y.; Hattori, A.; Kimura, T.; Hoshi, T.; Ishizu, T.; Seo, Y.; Sato, A.; Sekiguchi, Y.; Nogami, A.; Watanabe, S.; Horigome, H.; Kawakami, Y.; Aonuma, K.

2017-11-01

A 64-channel Nb-based DC-SQUID magnetocardiography (MCG) system was installed at the University of Tsukuba Hospital (UTH) in March 2007 after obtaining Japanese pharmaceutical approval and insurance reimbursement approval. In the period between 2008 and 2016, the total number of patients was 10 085. The heart diseases diagnosed in fetuses as well as adults are mainly atrial arrhythmia, abnormal repolarization, ventricular arrhythmia, and fetal arrhythmia. In most cases of insufficient diagnostic accuracy with electrocardiography, SQUID MCG precisely revealed these heart diseases as an abnormal electrical current distribution. Based on success in routine examinations, SQUID MCG is now an indispensable clinical instrument with diagnostic software tuned up during routine use at UTH.

The clinical value of daily routine chest radiographs in a mixed medical-surgical intensive care unit is low.

PubMed

Graat, Marleen E; Choi, Goda; Wolthuis, Esther K; Korevaar, Johanna C; Spronk, Peter E; Stoker, Jaap; Vroom, Margreeth B; Schultz, Marcus J

2006-02-01

The clinical value of daily routine chest radiographs (CXRs) in critically ill patients is unknown. We conducted this study to evaluate how frequently unexpected predefined major abnormalities are identified with daily routine CXRs, and how often these findings lead to a change in care for intensive care unit (ICU) patients. This was a prospective observational study conducted in a 28-bed, mixed medical-surgical ICU of a university hospital. Over a 5-month period, 2,457 daily routine CXRs were done in 754 consecutive ICU patients. The majority of these CXRs did not reveal any new predefined major finding. In only 5.8% of daily routine CXRs (14.3% of patients) was one or more new and unexpected abnormality encountered, including large atelectases (24 times in 20 patients), large infiltrates (23 in 22), severe pulmonary congestion (29 in 25), severe pleural effusion (13 in 13), pneumothorax/pneumomediastinum (14 in 13), and malposition of the orotracheal tube (32 in 26). Fewer than half of the CXRs with a new and unexpected finding were ultimately clinically relevant; in only 2.2% of all daily routine CXRs (6.4% of patients) did these radiologic abnormalities result in a change to therapy. Subgroup analysis revealed no differences between medical and surgical patients with regard to the incidence of new and unexpected findings on daily routine CXRs and the effect of new and unexpected CXR findings on daily care. In the ICU, daily routine CXRs seldom reveal unexpected, clinically relevant abnormalities, and they rarely prompt action. We propose that this diagnostic examination be abandoned in ICU patients.

Clinical significance of duodenal lymphangiectasia incidentally found during routine upper gastrointestinal endoscopy.

PubMed

Kim, J H; Bak, Y T; Kim, J S; Seol, S Y; Shin, B K; Kim, H K

2009-06-01

Although duodenal lymphangiectasia in individuals without clinical evidence of malabsorption has been reported, the prevalence and clinical significance in this situation are not yet known. The aim of this study was to evaluate the prevalence and clinical significance of incidentally found duodenal lymphangiectasia. A retrospective review of medical records was undertaken for consecutive patients who had undergone diagnostic upper endoscopy between January 2005 and June 2006. A prospective study was then performed in consecutive individuals undergoing routine upper endoscopy for health examination between July 2006 to October 2006. Endoscopic features of duodenal lymphangiectasia were classified into three types: (1) multiple scattered pinpoint white spots; (2) diffuse prominent villi with whitish-discolored tips; and (3) focal small whitish macule or nodule. The histologic grade of duodenal lymphangiectasia was classified according to the depth and severity of lymphatic duct dilatations. Prevalence and clinical data of incidentally found duodenal lymphangiectasia were evaluated in the retrospective and prospective studies. Among 1866 retrospective cases, duodenal lymphangiectasia was endoscopically suspected in 59 cases (3.2%), and histologically confirmed in 35 cases (1.9%). No clinical evidence of malabsorption was noted in the duodenal lymphangiectasia cases. The "scattered pinpoint white spots" type was the most frequently found endoscopic feature (40.0%). Duodenal lymphangiectasia was persistent in seven of 10 individuals who underwent repeat endoscopy after a median of 12 months. Among 134 prospective cases, duodenal lymphangiectasia was histologically confirmed in 12 cases (8.9%). There was no significant clinical difference between groups with and without duodenal lymphangiectasia. Lymphatic duct dilatation was histologically more severe in the "focal small whitish macule or nodule" type than in the other types. Duodenal lymphangiectasia without clinical

Traceability Assessment and Performance Evaluation of Results for Measurement of Abbott Clinical Chemistry Assays on 4 Chemistry Analyzers.

PubMed

Lim, Jinsook; Song, Kyung Eun; Song, Sang Hoon; Choi, Hyun-Jung; Koo, Sun Hoe; Kwon, Gye Choel

2016-05-01

-The traceability of clinical results to internationally recognized and accepted reference materials and reference measurement procedures has become increasingly important. Therefore, the establishment of traceability has become a mandatory requirement for all in vitro diagnostics devices. -To evaluate the traceability of the Abbott Architect c8000 system (Abbott Laboratories, Abbott Park, Illinois), consisting of calibrators and reagents, across 4 different chemistry analyzers, and to evaluate its general performance on the Toshiba 2000FR NEO (Toshiba Medical Systems Corporation, Otawara-shi, Tochigi-ken, Japan). -For assessment of traceability, secondary reference materials were evaluated 5 times, and then bias was calculated. Precision, linearity, and carryover were determined according to the guidelines of the Clinical and Laboratory Standards Institute (Wayne, Pennsylvania). -The biases from 4 different analyzers ranged from -2.33% to 2.70% on the Toshiba 2000FR NEO, -2.33% to 5.12% on the Roche Hitachi 7600 (Roche Diagnostics International, Basel, Switzerland), -0.93% to 2.87% on the Roche Modular, and -2.16% to 2.86% on the Abbott Architect c16000. The total coefficients of variance of all analytes were less than 5%. The coefficients of determination (R(2)) were more than 0.9900. The carryover rate ranged from -0.54% to 0.17%. -Abbott clinical chemistry assays met the performance criteria based on desirable biological variation for precision, bias, and total error. They also showed excellent linearity and carryover. Therefore, these clinical chemistry assays were found to be accurate and reliable and are readily applicable on the various platforms used in this study.

Use of structured musculoskeletal examination routines in undergraduate medical education and postgraduate clinical practice - a UK survey.

PubMed

Baker, Kenneth F; Jandial, Sharmila; Thompson, Ben; Walker, David; Taylor, Ken; Foster, Helen E

2016-10-21

Structured examination routines have been developed as educational resources for musculoskeletal clinical skills teaching, including Gait-Arms-Legs-Spine (GALS), Regional Examination of the Musculoskeletal System (REMS) and paediatric GALS (pGALS). In this study, we aimed to assess the awareness and use of these examination routines in undergraduate medical teaching in UK medical schools and UK postgraduate clinical practice. Electronic questionnaires were distributed to adult and paediatric musculoskeletal teaching leads at UK medical schools and current UK doctors in training. Responses were received from 67 tutors representing teaching at 22/33 [67 %] of all UK medical schools, and 70 trainee doctors across a range of postgraduate training specialities. There was widespread adoption, at responding medical schools, of the adult examination routines within musculoskeletal teaching (GALS: 14/16 [88 %]; REMS: 12/16 [75 %]) and assessment (GALS: 13/16 [81 %]; REMS: 12/16 [75 %]). More trainees were aware of GALS (64/70 [91 %]) than REMS (14/67 [21 %]). Of the 39 trainees who used GALS in their clinical practice, 35/39 [90 %] reported that it had improved their confidence in musculoskeletal examination. Of the 17/22 responding medical schools that included paediatric musculoskeletal examination within their curricula, 15/17 [88 %] used the pGALS approach and this was included within student assessment at 4 medical schools. We demonstrate the widespread adoption of these examination routines in undergraduate education and significant uptake in postgraduate clinical practice. Further study is required to understand their impact upon clinical performance.

Effects of food or sleep deprivation during civilian survival training on clinical chemistry variables.

PubMed

Ståhle, Lars; Granström, Elisabeth; Ljungdahl Ståhle, Ewa; Isaksson, Sven; Samuelsson, Anders; Rudling, Mats; Sepp, Harry

2013-06-01

To describe clinical chemistry and weight changes after short-term food or sleep deprivation or multiple deprivations during civilian survival training. Data from one baseline-controlled two-period crossover study designed to compare sleep deprivation for up to 50 hours with food deprivation for up to 66 hours (n = 12) and data from regular multiple-deprivations survival training comparing participants (n = 33) with nondeprived instructors (n = 10). Food deprivation was associated with decreased body weight, blood glucose, serum triglycerides, sodium, chloride, and urine pH, and there were increases in blood and urine ketones and serum free fatty acids. Sleep deprivation was associated with a minor decrease in hemoglobin and erythrocyte particle count and volume fraction and an increase in leukocytes. The clinical chemistry and body weight changes associated with food deprivation were qualitatively similar to those observed in fasting obese patients but developed quicker in the survival training setting. Sleep deprivation had few effects on the clinical chemistry profile except for hematological variables. Physicians evaluating clinical chemistry data from patients subjected to short-term food or sleep deprivation should take the physiological state into account in their assessment. Copyright © 2013 Wilderness Medical Society. Published by Elsevier Inc. All rights reserved.

Gamification of Clinical Routine: The Dr. Fill Approach.

PubMed

Bukowski, Mark; Kühn, Martin; Zhao, Xiaoqing; Bettermann, Ralf; Jonas, Stephan

2016-01-01

Gamification is used in clinical context in the health care education. Furthermore, it has shown great promises to improve the performance of the health care staff in their daily routine. In this work we focus on the medication sorting task, which is performed manually in hospitals. This task is very error prone and needs to be performed daily. Nevertheless, errors in the medication are crucial and lead to serious complications. In this work we present a real world gamification approach of the medication sorting task in a patient's daily pill organizer. The player of the game needs to sort the correct medication into the correct dispenser slots and is rewarded or punished in real time. At the end of the game, a score is given and the user can register in a leaderboard.

Delivering value in dermatology: insights from skin cancer detection in routine clinical visits.

PubMed

Enamandram, Monica; Duncan, Lyn M; Kimball, Alexandra B

2015-02-01

There are increasing demands to demonstrate and report on outcomes in dermatology. Skin cancer diagnosis through skin examination has been well studied, and is promising as a value-delivering intervention. This study seeks to identify the rate of skin cancer diagnosis during routine visits to a large tertiary dermatology clinic. Medical records of patients presenting for routine dermatologic care at Massachusetts General Hospital between March 28 and September 28, 2012, were retrospectively reviewed. All patients given a diagnosis of nonmelanoma skin cancer (NMSC) confirmed on biopsy specimen were identified. Billing data were used to identify the total number of patients evaluated during the study period. NMSC was diagnosed in 1266 skin biopsy specimens from 1047 (7.0%) of the 14,829 patients who presented for routine care. In all, 55% of patients with NMSC were men (mean age 70 years). Chief symptoms of patients with NMSC included general dermatologic concerns (37%), routine cancer screening (43%), and specific lesion(s) of concern (19%). Retrospective design and restriction to a single institution may limit the generalizability of our findings. The incidence of NMSC in routine dermatology is high; these findings validate the value of care provided by dermatologists and highlight the likely increasing need for their diagnostic skills as the population ages in the United States. Copyright © 2014 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

Identifying complications of interventional procedures from UK routine healthcare databases: a systematic search for methods using clinical codes.

PubMed

Keltie, Kim; Cole, Helen; Arber, Mick; Patrick, Hannah; Powell, John; Campbell, Bruce; Sims, Andrew

2014-11-28

Several authors have developed and applied methods to routine data sets to identify the nature and rate of complications following interventional procedures. But, to date, there has been no systematic search for such methods. The objective of this article was to find, classify and appraise published methods, based on analysis of clinical codes, which used routine healthcare databases in a United Kingdom setting to identify complications resulting from interventional procedures. A literature search strategy was developed to identify published studies that referred, in the title or abstract, to the name or acronym of a known routine healthcare database and to complications from procedures or devices. The following data sources were searched in February and March 2013: Cochrane Methods Register, Conference Proceedings Citation Index - Science, Econlit, EMBASE, Health Management Information Consortium, Health Technology Assessment database, MathSciNet, MEDLINE, MEDLINE in-process, OAIster, OpenGrey, Science Citation Index Expanded and ScienceDirect. Of the eligible papers, those which reported methods using clinical coding were classified and summarised in tabular form using the following headings: routine healthcare database; medical speciality; method for identifying complications; length of follow-up; method of recording comorbidity. The benefits and limitations of each approach were assessed. From 3688 papers identified from the literature search, 44 reported the use of clinical codes to identify complications, from which four distinct methods were identified: 1) searching the index admission for specified clinical codes, 2) searching a sequence of admissions for specified clinical codes, 3) searching for specified clinical codes for complications from procedures and devices within the International Classification of Diseases 10th revision (ICD-10) coding scheme which is the methodology recommended by NHS Classification Service, and 4) conducting manual clinical

Mould routine identification in the clinical laboratory by matrix-assisted laser desorption ionization time-of-flight mass spectrometry.

PubMed

Cassagne, Carole; Ranque, Stéphane; Normand, Anne-Cécile; Fourquet, Patrick; Thiebault, Sandrine; Planard, Chantal; Hendrickx, Marijke; Piarroux, Renaud

2011-01-01

MALDI-TOF MS recently emerged as a valuable identification tool for bacteria and yeasts and revolutionized the daily clinical laboratory routine. But it has not been established for routine mould identification. This study aimed to validate a standardized procedure for MALDI-TOF MS-based mould identification in clinical laboratory. First, pre-extraction and extraction procedures were optimized. With this standardized procedure, a 143 mould strains reference spectra library was built. Then, the mould isolates cultured from sequential clinical samples were prospectively subjected to this MALDI-TOF MS based-identification assay. MALDI-TOF MS-based identification was considered correct if it was concordant with the phenotypic identification; otherwise, the gold standard was DNA sequence comparison-based identification. The optimized procedure comprised a culture on sabouraud-gentamicin-chloramphenicol agar followed by a chemical extraction of the fungal colonies with formic acid and acetonitril. The identification was done using a reference database built with references from at least four culture replicates. For five months, 197 clinical isolates were analyzed; 20 were excluded because they were not identified at the species level. MALDI-TOF MS-based approach correctly identified 87% (154/177) of the isolates analyzed in a routine clinical laboratory activity. It failed in 12% (21/177), whose species were not represented in the reference library. MALDI-TOF MS-based identification was correct in 154 out of the remaining 156 isolates. One Beauveria bassiana was not identified and one Rhizopus oryzae was misidentified as Mucor circinelloides. This work's seminal finding is that a standardized procedure can also be used for MALDI-TOF MS-based identification of a wide array of clinically relevant mould species. It thus makes it possible to identify moulds in the routine clinical laboratory setting and opens new avenues for the development of an integrated MALDI-TOF MS

Fasting Is Not Routinely Required for Determination of a Lipid Profile: Clinical and Laboratory Implications Including Flagging at Desirable Concentration Cutpoints-A Joint Consensus Statement from the European Atherosclerosis Society and European Federation of Clinical Chemistry and Laboratory Medicine.

PubMed

Nordestgaard, Børge G; Langsted, Anne; Mora, Samia; Kolovou, Genovefa; Baum, Hannsjörg; Bruckert, Eric; Watts, Gerald F; Sypniewska, Grazyna; Wiklund, Olov; Borén, Jan; Chapman, M John; Cobbaert, Christa; Descamps, Olivier S; von Eckardstein, Arnold; Kamstrup, Pia R; Pulkki, Kari; Kronenberg, Florian; Remaley, Alan T; Rifai, Nader; Ros, Emilio; Langlois, Michel

2016-07-01

is >13 mmol/L (500 mg/dL), for heterozygous familial hypercholesterolemia when LDL cholesterol is >5 mmol/L (190 mg/dL), and for very high cardiovascular risk when lipoprotein(a) >150 mg/dL (99th percentile). We recommend that non-fasting blood samples be routinely used for the assessment of plasma lipid profiles. Laboratory reports should flag abnormal values on the basis of desirable concentration cutpoints. Non-fasting and fasting measurements should be complementary but not mutually exclusive. © 2016 American Association for Clinical Chemistry.

Real-Time Patient Survey Data During Routine Clinical Activities for Rapid-Cycle Quality Improvement

PubMed Central

Jones, Robert E

2015-01-01

Background Surveying patients is increasingly important for evaluating and improving health care delivery, but practical survey strategies during routine care activities have not been available. Objective We examined the feasibility of conducting routine patient surveys in a primary care clinic using commercially available technology (Web-based survey creation, deployment on tablet computers, cloud-based management of survey data) to expedite and enhance several steps in data collection and management for rapid quality improvement cycles. Methods We used a Web-based data management tool (survey creation, deployment on tablet computers, real-time data accumulation and display of survey results) to conduct four patient surveys during routine clinic sessions over a one-month period. Each survey consisted of three questions and focused on a specific patient care domain (dental care, waiting room experience, care access/continuity, Internet connectivity). Results Of the 727 available patients during clinic survey days, 316 patients (43.4%) attempted the survey, and 293 (40.3%) completed the survey. For the four 3-question surveys, the average time per survey was overall 40.4 seconds, with a range of 5.4 to 20.3 seconds for individual questions. Yes/No questions took less time than multiple choice questions (average 9.6 seconds versus 14.0). Average response time showed no clear pattern by order of questions or by proctor strategy, but monotonically increased with number of words in the question (<20 words, 21-30 words, >30 words)—8.0, 11.8, 16.8, seconds, respectively. Conclusions This technology-enabled data management system helped capture patient opinions, accelerate turnaround of survey data, with minimal impact on a busy primary care clinic. This new model of patient survey data management is feasible and sustainable in a busy office setting, supports and engages clinicians in the quality improvement process, and harmonizes with the vision of a learning health

Real-time patient survey data during routine clinical activities for rapid-cycle quality improvement.

PubMed

Wofford, James Lucius; Campos, Claudia L; Jones, Robert E; Stevens, Sheila F

2015-03-12

Surveying patients is increasingly important for evaluating and improving health care delivery, but practical survey strategies during routine care activities have not been available. We examined the feasibility of conducting routine patient surveys in a primary care clinic using commercially available technology (Web-based survey creation, deployment on tablet computers, cloud-based management of survey data) to expedite and enhance several steps in data collection and management for rapid quality improvement cycles. We used a Web-based data management tool (survey creation, deployment on tablet computers, real-time data accumulation and display of survey results) to conduct four patient surveys during routine clinic sessions over a one-month period. Each survey consisted of three questions and focused on a specific patient care domain (dental care, waiting room experience, care access/continuity, Internet connectivity). Of the 727 available patients during clinic survey days, 316 patients (43.4%) attempted the survey, and 293 (40.3%) completed the survey. For the four 3-question surveys, the average time per survey was overall 40.4 seconds, with a range of 5.4 to 20.3 seconds for individual questions. Yes/No questions took less time than multiple choice questions (average 9.6 seconds versus 14.0). Average response time showed no clear pattern by order of questions or by proctor strategy, but monotonically increased with number of words in the question (<20 words, 21-30 words, >30 words)-8.0, 11.8, 16.8, seconds, respectively. This technology-enabled data management system helped capture patient opinions, accelerate turnaround of survey data, with minimal impact on a busy primary care clinic. This new model of patient survey data management is feasible and sustainable in a busy office setting, supports and engages clinicians in the quality improvement process, and harmonizes with the vision of a learning health care system.

[Management of aflibercept in routine clinical practice].

PubMed

Cabrera López, F

2015-03-01

Aflibercept is a new anti-vegf drug that, unlike ranibizumab and bevacizumab blocks both vegf-A and placental growth factor. Moreover, it binds with much greater strength and affinity to human VEGF-A165 than other endogenous vegf receptors, conferring it with a more extended effect and allowing a lower frequency of intravitreal injections. This facilitates the adoption of fixed treatment regimens other than monthly or individual regimens such as "treat and extend". Aflibercept is indicated for the treatment of neovascular (exudative) age-related macular degeneration (ARMD), visual alteration due to macular edema secondary to central retinal vein occlusion (CRVO) and visual alteration due to diabetic macular edema (DME). The present article reviews the management of aflibercept in routine clinical practice, based on the specifications of its new core data sheet, which includes all the therapeutic indications in which its use has been approved and evaluating the distinct alternatives and treatment regimens after the initial loading doses. Copyright © 2015 Sociedad Española de Oftalmología. Published by Elsevier España, S.L.U. All rights reserved.

Allergy to kiwi: is component-resolved diagnosis in routine clinical practice really impossible?

PubMed

Asero, R

2012-04-01

Kiwi allergy is frequent and can be the result of sensitization to a number of allergens showing different physicochemical characteristics. Component-resolved diagnosis of kiwi allergy is still unavailable in routine clinical practice. To investigate whether component resolved-diagnosis of kiwi allergy can be, at least in part, carried out by a proper combination of routinely available diagnostic tools. 63 adults with plant food allergy were studied 36 were kiwi-allergic while 27 were kiwi-tolerant and served as controls. Patients and controls underwent SPT with commercial peach and kiwi extracts, and with aprofilin-enriched date palm pollen extract (all by ALK-Abellò), and the measurement of IgE to birch, kiwi, and natural rubber latex. The in-vitro test showed poor sensitivity and specificity, as it scored positive in about 50% of patients and controls irrespective of clinical allergy to kiwi. The kiwi SPT showed overall poor sensitivity; however, it scored negative in all subjects with pollen food-allergy syndrome, was weakly positive in some lipid transfer protein-hypersensitive/kiwi tolerant subjects and in one latex-sensitized subject, and strongly positive in all subjects with primary kiwi sensitization. SPT with this commercial kiwi extract sensitively and specifically detects patients reacting to specific kiwi allergens. This can be useful to detect patients that are at risk of potentially severe reactions, particularly in case of co-sensitization to labile allergens, while we wait that the whole spectrum of kiwi allergens becomes available for routine in-vitro testing.

Biomedical data mining in clinical routine: expanding the impact of hospital information systems.

PubMed

Müller, Marcel; Markó, Kornel; Daumke, Philipp; Paetzold, Jan; Roesner, Arnold; Klar, Rüdiger

2007-01-01

In this paper we want to describe how the promising technology of biomedical data mining can improve the use of hospital information systems: a large set of unstructured, narrative clinical data from a dermatological university hospital like discharge letters or other dermatological reports were processed through a morpho-semantic text retrieval engine ("MorphoSaurus") and integrated with other clinical data using a web-based interface and brought into daily clinical routine. The user evaluation showed a very high user acceptance - this system seems to meet the clinicians' requirements for a vertical data mining in the electronic patient records. What emerges is the need for integration of biomedical data mining into hospital information systems for clinical, scientific, educational and economic reasons.

Technical solutions for simultaneous MEG and SEEG recordings: towards routine clinical use.

PubMed

Badier, J M; Dubarry, A S; Gavaret, M; Chen, S; Trébuchon, A S; Marquis, P; Régis, J; Bartolomei, F; Bénar, C G; Carron, R

2017-09-21

The simultaneous recording of intracerebral EEG (stereotaxic EEG, SEEG) and magnetoencephalography (MEG) is a promising strategy that provides both local and global views on brain pathological activity. Yet, acquiring simultaneous signals poses difficult technical issues that hamper their use in clinical routine. Our objective was thus to develop a set of solutions for recording a high number of SEEG channels while preserving signal quality. We recorded data in a patient with drug resistant epilepsy during presurgical evaluation. We used dedicated insertion screws and optically insulated amplifiers. We recorded 137 SEEG contacts on 10 depth electrodes (5-15 contacts each) and 248 MEG channels (magnetometers). Signal quality was assessed by comparing the distribution of RMS values in different frequency bands to a reference set of MEG acquisitions. The quality of signals was excellent for both MEG and SEEG; for MEG, it was comparable to that of MEG signals without concurrent SEEG. Discharges involving several structures on SEEG were visible on MEG, whereas discharges limited in space were not seen at the surface. SEEG can now be recorded simultaneously with whole-head MEG in routine. This opens new avenues, both methodologically for understanding signals and improving signal processing methods, and clinically for future combined analyses.

Vascular access clinic results before and after implementing a multidisciplinary approach adding routine Doppler ultrasound.

PubMed

Aragoncillo Sauco, Inés; Ligero Ramos, José Manuel; Vega Martínez, Almudena; Morales Muñoz, Ángel Luis; Abad Estébanez, Soraya; Macías Carmona, Nicolás; Ruiz Chiriboga, Diego; García Pajares, Rosario; Cervera Bravo, Teresa; López-Gómez, Juan Manuel; Manzano Grossi, Soledad; Menéndez Sánchez, Elena; Río Gomez, Javier; García Prieto, Ana María; Linares Grávalos, Tania; Garcia Boyano, Fernando; Reparaz Asensio, Luis Manuel; Albalate Ramón, Marta; de Sequera Ortiz, Patricia; Gil Casares, Beatriz; Ampuero Mencía, Jara; Castellano, Sandra; Martín Pérez, Belén; Conty, José Luís Martín; Santos Garcia, Alba; Luño Fernandez, José

2018-06-11

A multidisciplinary approach and Doppler ultrasound (DU) assessment for the creation and maintenance of arteriovenous fistulas (AVF) for haemodialysis can improve prevalence and patency. The aim of this study was to analyse the impact of a new multidisciplinary vascular access (VA) clinic with routine DU. We analysed the VA clinic results from 2014 and 2015, before and after the implementation of a multidisciplinary team protocol (vascular surgeon/nephrologist) with routine DU in preoperative mapping and prevalent AVF. We analysed 345 and 364 patients from 2014 and 2015 respectively. The number of surgical interventions was similar in both periods (p=.289), with a trend towards an increase in preventive surgical repair of AVF in 2015 (17 vs. 29, p=.098). 155 vs. 169 new AVF were performed in 2014 and 2015, with a significantly lower primary failure rate in 2015 (26.4 vs. 15.3%, p=.015), and a non-significant increase in radiocephalic AVF, 25.8 vs. 33.2% (n=40 vs. 56), p=.159. The concordance between the indication at the clinic and the surgery performed also increased (81.3 vs. 93.5%, p=.001). Throughout 2015 fewer complementary imaging test were requested from the clinic (78 vs. 35, p <.001), with a corresponding reduction in costs (€87,716 vs. €59,445). Multidisciplinary approach with routine DU can improve VA results, with a decrease in primary failure rate, higher likelihood of radiocephalic AVF, better management of dis-functioning AVF and lower radiological test costs. Copyright © 2018 Sociedad Española de Nefrología. Published by Elsevier España, S.L.U. All rights reserved.

(Short overview of the Mexican Society of Clinical Chemistry meetings)

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

Burtis, C.

1991-01-01

Organized and chaired session on instrument evaluation at the XIV Congreso Nacional De Quimica Clinica which is the National Meeting of the Mexican Society of Clinical Chemistry. In addition, I presented a paper on calibration at a Congress workshop and spoke on the impact of technology in a symposium on quality control.

COPD management: role of symptom assessment in routine clinical practice

PubMed Central

van der Molen, Thys; Miravitlles, Marc; Kocks, Janwillem WH

2013-01-01

Patients with chronic obstructive pulmonary disease (COPD) present with a variety of symptoms that significantly impair health-related quality of life. Despite this, COPD treatment and its management are mainly based on lung function assessments. There is increasing evidence that conventional lung function measures alone do not correlate well with COPD symptoms and their associated impact on patients’ everyday lives. Instead, symptoms should be assessed routinely, preferably by using patient-centered questionnaires that provide a more accurate guide to the actual burden of COPD. Numerous questionnaires have been developed in an attempt to find a simple and reliable tool to use in everyday clinical practice. In this paper, we review three such patient-reported questionnaires recommended by the latest Global Initiative for Chronic Obstructive Lung Disease guidelines, ie, the modified Medical Research Council questionnaire, the clinical COPD questionnaire, and the COPD Assessment Test, as well as other symptom-specific questionnaires that are currently being developed. PMID:24143085

An alternative clinical routine for subjective refraction based on power vectors with trial frames.

PubMed

María Revert, Antonia; Conversa, Maria Amparo; Albarrán Diego, César; Micó, Vicente

2017-01-01

Subjective refraction determines the final point of refractive error assessment in most clinical environments and its foundations have remained unchanged for decades. The purpose of this paper is to compare the results obtained when monocular subjective refraction is assessed in trial frames by a new clinical procedure based on a pure power vector interpretation with conventional clinical refraction procedures. An alternative clinical routine is described that uses power vector interpretation with implementation in trial frames. Refractive error is determined in terms of: (i) the spherical equivalent (M component), and (ii) a pair of Jackson Crossed Cylinder lenses oriented at 0°/90° (J 0 component) and 45°/135° (J 45 component) for determination of astigmatism. This vector subjective refraction result (VR) is compared separately for right and left eyes of 25 subjects (mean age, 35 ± 4 years) against conventional sphero-cylindrical subjective refraction (RX) using a phoropter. The VR procedure was applied with both conventional tumbling E optotypes (VR1) and modified optotypes with oblique orientation (VR2). Bland-Altman plots and intra-class correlation coefficient showed good agreement between VR, and RX (with coefficient values above 0.82) and anova showed no significant differences in any of the power vector components between RX and VR. VR1 and VR2 procedure results were similar (p ≥ 0.77). The proposed routine determines the three components of refractive error in power vector notation [M, J 0 , J 45 ], with a refraction time similar to the one used in conventional subjective procedures. The proposed routine could be helpful for inexperienced clinicians and for experienced clinicians in those cases where it is difficult to get a valid starting point for conventional RX (irregular corneas, media opacities, etc.) and for refractive situations/places with inadequate refractive facilities/equipment. © 2016 The Authors Ophthalmic & Physiological

Evaluation of Cobas Integra 800 under simulated routine conditions in six laboratories.

PubMed

Redondo, Francisco L; Bermudez, Pilar; Cocco, Claudio; Colella, Francesca; Graziani, Maria Stella; Fiehn, Walter; Hierla, Thomas; Lemoël, Gisèle; Belliard, AnneMarie; Manene, Dieudonne; Meziani, Mourad; Liebel, Maryann; McQueen, Matthew J; Stockmann, Wolfgang

2003-03-01

The new selective access analyser Cobas Integra 800 from Roche Diagnostics was evaluated in an international multicentre study at six sites. Routine simulation experiments showed good performance and full functionality of the instrument and provocation of anomalous situations generated no problems. The new features on Cobas Integra 800, namely clot detection and dispensing control, worked according to specifications. The imprecision of Cobas Integra 800 fulfilled the proposed quality specifications regarding imprecision of analytical systems for clinical chemistry with few exceptions. Claims for linearity, drift, and carry-over were all within the defined specifications, except urea linearity. Interference exists in some cases, as could be expected due to the chemistries applied. Accuracy met the proposed quality specifications, except in some special cases. Method comparisons with Cobas Integra 700 showed good agreement; comparisons with other analysis systems yielded in several cases explicable deviations. Practicability of Cobas Integra 800 met or exceeded the requirements for more than 95% of all attributes rated. The strong points of the new analysis system were reagent handling, long stability of calibration curves, high number of tests on board, compatibility of the sample carrier to other Roche systems, and the sample integrity check for more reliable analytical results. The improvement of the workflow offered by the 5-position rack and STAT handling like on Cobas Integra 800 makes the instrument attractive for further consolidation in the medium-sized laboratory, for dedicated use of special analytes, and/or as back-up in the large routine laboratory.

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.

Evaluation of an instructional model to teach clinically relevant medicinal chemistry in a campus and a distance pathway.

PubMed

Alsharif, Naser Z; Galt, Kimberly A

2008-04-15

To evaluate an instructional model for teaching clinically relevant medicinal chemistry. An instructional model that uses Bloom's cognitive and Krathwohl's affective taxonomy, published and tested concepts in teaching medicinal chemistry, and active learning strategies, was introduced in the medicinal chemistry courses for second-professional year (P2) doctor of pharmacy (PharmD) students (campus and distance) in the 2005-2006 academic year. Student learning and the overall effectiveness of the instructional model were assessed. Student performance after introducing the instructional model was compared to that in prior years. Student performance on course examinations improved compared to previous years. Students expressed overall enthusiasm about the course and better understood the value of medicinal chemistry to clinical practice. The explicit integration of the cognitive and affective learning objectives improved student performance, student ability to apply medicinal chemistry to clinical practice, and student attitude towards the discipline. Testing this instructional model provided validation to this theoretical framework. The model is effective for both our campus and distance-students. This instructional model may also have broad-based applications to other science courses.

Real-Time PCR in Clinical Microbiology: Applications for Routine Laboratory Testing

PubMed Central

Espy, M. J.; Uhl, J. R.; Sloan, L. M.; Buckwalter, S. P.; Jones, M. F.; Vetter, E. A.; Yao, J. D. C.; Wengenack, N. L.; Rosenblatt, J. E.; Cockerill, F. R.; Smith, T. F.

2006-01-01

Real-time PCR has revolutionized the way clinical microbiology laboratories diagnose many human microbial infections. This testing method combines PCR chemistry with fluorescent probe detection of amplified product in the same reaction vessel. In general, both PCR and amplified product detection are completed in an hour or less, which is considerably faster than conventional PCR detection methods. Real-time PCR assays provide sensitivity and specificity equivalent to that of conventional PCR combined with Southern blot analysis, and since amplification and detection steps are performed in the same closed vessel, the risk of releasing amplified nucleic acids into the environment is negligible. The combination of excellent sensitivity and specificity, low contamination risk, and speed has made real-time PCR technology an appealing alternative to culture- or immunoassay-based testing methods for diagnosing many infectious diseases. This review focuses on the application of real-time PCR in the clinical microbiology laboratory. PMID:16418529

Identification and treatment of patients with nicotine problems in routine clinical psychiatry practice.

PubMed

Montoya, Ivan D; Herbeck, Diane M; Svikis, Dace S; Pincus, Harold Alan

2005-01-01

The aim of this study is to assess the rates of nicotine problems diagnosed by psychiatrists, the characteristics of psychiatric patients who smoke, and the services provided to them in routine psychiatric practice. Data were obtained by asking psychiatrists participating in the American Psychiatric Institute for Psychiatric Research and Education's Practice Research Network to complete a self-administered questionnaire to provide detailed sociodemographic, clinical, and health plan information on three of their patients seen during routine clinical practice. A total of 615 psychiatrists provided information on 1,843 patients, of which 280 (16.6%) were reported to have a current nicotine problem. Of these, 9.1% were reported to receive treatment for nicotine dependence. Patients with nicotine problems were significantly more likely to be males, divorced or separated, disabled, and uninsured, and have fewer years of education. They also had significantly more co-morbid psychiatric disorders, particularly schizophrenia or alcohol/substance use disorders; a lower Global Assessment Functioning score; and poorer treatment compliance than their counterparts. The results suggest a very low rate of identification and treatment of nicotine problems among patients treated by psychiatrists, even though psychiatric patients who smoke seem to have more clinical and psychosocial stressors and more severe psychiatric problems than those who do not smoke. Programs should be developed to raise the awareness and ability of psychiatrists to diagnose and treat patients with nicotine problems, with a particular emphasis on the increased medical and psychosocial needs of psychiatric patients who smoke.

Clinical Laboratory Practice Recommendations for the Use of Cardiac Troponin in Acute Coronary Syndrome: Expert Opinion from the Academy of the American Association for Clinical Chemistry and the Task Force on Clinical Applications of Cardiac Bio-Markers of the International Federation of Clinical Chemistry and Laboratory Medicine.

PubMed

Wu, Alan H B; Christenson, Robert H; Greene, Dina N; Jaffe, Allan S; Kavsak, Peter A; Ordonez-Llanos, Jordi; Apple, Fred S

2018-04-01

This document is an essential companion to the third iteration of the National Academy of Clinical Biochemistry [NACB, 8 now the American Association for Clinical Chemistry (AACC) Academy] Laboratory Medicine Practice Guidelines (LMPG) on cardiac markers. The expert consensus recommendations were drafted in collaboration with the International Federation of Clinical Chemistry and Laboratory Medicine Task Force on Clinical Applications of Bio-Markers (IFCC TF-CB). We determined that there is sufficient clinical guidance on the use of cardiac troponin (cTn) testing from clinical practice groups. Thus, in this expert consensus document, we focused on clinical laboratory practice recommendations for high-sensitivity (hs)-cTn assays. This document utilized the expert opinion class of evidence to focus on the following 10 topics: ( a ) quality control (QC) utilization, ( b ) validation of the lower reportable analytical limits, ( c ) units to be used in reporting measurable concentrations for patients and QC materials, ( d ) 99th percentile sex-specific upper reference limits to define the reference interval; ( e ) criteria required to define hs-cTn assays, ( f ) communication with clinicians and the laboratory's role in educating clinicians regarding the influence of preanalytic and analytic problems that can confound assay results, ( g ) studies on hs-cTn assays and how authors need to document preanalytical and analytical variables, ( h ) harmonizing and standardizing assay results and the role of commutable materials, ( i ) time to reporting of results from sample receipt and sample collection, and ( j ) changes in hs-cTn concentrations over time and the role of both analytical and biological variabilities in interpreting results of serial blood collections. © 2017 American Association for Clinical Chemistry.

Identification of metabolites, clinical chemistry markers and transcripts associated with hepatotoxicity.

PubMed

Buness, Andreas; Roth, Adrian; Herrmann, Annika; Schmitz, Oliver; Kamp, Hennicke; Busch, Kristina; Suter, Laura

2014-01-01

Early and accurate pre-clinical and clinical biomarkers of hepatotoxicity facilitate the drug development process and the safety monitoring in clinical studies. We selected eight known model compounds to be administered to male Wistar rats to identify biomarkers of drug induced liver injury (DILI) using transcriptomics, metabolite profiling (metabolomics) and conventional endpoints. We specifically explored early biomarkers in serum and liver tissue associated with histopathologically evident acute hepatotoxicity. A tailored data analysis strategy was implemented to better differentiate animals with no treatment-related findings in the liver from animals showing evident hepatotoxicity as assessed by histopathological analysis. From the large number of assessed parameters, our data analysis strategy allowed us to identify five metabolites in serum and five in liver tissue, 58 transcripts in liver tissue and seven clinical chemistry markers in serum that were significantly associated with acute hepatotoxicity. The identified markers comprised metabolites such as taurocholic acid and putrescine (measured as sum parameter together with agmatine), classical clinical chemistry markers like AST (aspartate aminotransferase), ALT (alanine aminotransferase), and bilirubin, as well as gene transcripts like Igfbp1 (insulin-like growth factor-binding protein 1) and Egr1 (early growth response protein 1). The response pattern of the identified biomarkers was concordant across all types of parameters and sample matrices. Our results suggest that a combination of several of these biomarkers could significantly improve the robustness and accuracy of an early diagnosis of hepatotoxicity.

Quantum Chemistry; A concise introduction for students of physics, chemistry, biochemistry and materials science

NASA Astrophysics Data System (ADS)

Thakkar, Ajit J.

2017-09-01

This book provides non-specialists with a basic understanding of the underlying concepts of quantum chemistry. It is both a text for second- or third-year undergraduates and a reference for researchers who need a quick introduction or refresher. All chemists and many biochemists, materials scientists, engineers, and physicists routinely use spectroscopic measurements and electronic structure computations in their work. The emphasis of Quantum Chemistry on explaining ideas rather than enumerating facts or presenting procedural details makes this an excellent foundation text/reference.

Toshiba General Hospital PACS for routine in- and outpatient clinics

NASA Astrophysics Data System (ADS)

Toshimitsu, Akihiro; Okazaki, Nobuo; Kura, Hiroyuki; Nishihara, Eitaro; Tsubura, Shinichi

1996-05-01

The Toshiba General Hospital introduced a departmental RIS/PACS (Radiology Information System/Picture Archiving and Communication System) in the radiology department in May, 1993. It has been used routinely since that time. In order to provide efficient means for clinicians to find and read many images, the system has been expanded to the neurosurgery and urology clinics and wards since May, 1995, and five image referring workstations now provide digital images to clinicians. In this paper we discuss an algorithm for image migration, one of the key issues to accomplish the expansion to outpatient clinics successfully, and propose the WYWIWYG (what you want is what you get) image transfer logic. This is the logic used to transfer images that physicians require refer without increasing the traffic between the image server and referring workstations. We accomplish the WYWIWYG logic by prioritizing exams the physicians have not yet viewed and by finding historical exams according to the modality, anatomy, and marking. Clinicians gave us comments from their first use of the system and suggested that the PACS enables clinicians to review images more efficiently compared to a film-based system. Our experience suggests that it is a key to the effective application of PACS in outpatient clinics to incorporate consideration patterns of clinicians on the migration algorithm.

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.

A Bridge between Two Cultures: Uncovering the Chemistry Concepts Relevant to the Nursing Clinical Practice

ERIC Educational Resources Information Center

Brown, Corina E.; Henry, Melissa L. M.; Barbera, Jack; Hyslop, Richard M.

2012-01-01

This study focused on the undergraduate course that covers basic topics in general, organic, and biological (GOB) chemistry at a mid-sized state university in the western United States. The central objective of the research was to identify the main topics of GOB chemistry relevant to the clinical practice of nursing. The collection of data was…

The Effectiveness of Online Cognitive Behavioral Treatment in Routine Clinical Practice

PubMed Central

Ruwaard, Jeroen; Lange, Alfred; Schrieken, Bart; Dolan, Conor V.; Emmelkamp, Paul

2012-01-01

Context Randomized controlled trails have identified online cognitive behavioral therapy as an efficacious intervention in the management of common mental health disorders. Objective To assess the effectiveness of online CBT for different mental disorders in routine clinical practice. Design An uncontrolled before-after study, with measurements at baseline, posttest, 6-week follow-up, and 1-year follow-up. Participants & Setting 1500 adult patients (female: 67%; mean age: 40 years) with a GP referral for psychotherapy were treated at a Dutch online mental health clinic for symptoms of depression (n = 413), panic disorder (n = 139), posttraumatic stress (n = 478), or burnout (n = 470). Interventions Manualized, web-based, therapist-assisted CBT, of which the efficacy was previously demonstrated in a series of controlled trials. Standardized duration of treatment varied from 5 weeks (online CBT for Posttraumatic stress) to 16 weeks (online CBT for Depression). Main Outcome Measures Validated self-report questionnaires of specific and general psychopathology, including the Beck Depression Inventory, the Impact of Event Scale, the Panic Disorder Severity Scale-Self Report, the Oldenburg Burnout Inventory, and the Depression Anxiety Stress Scales. Results Treatment adherence was 71% (n = 1071). Study attrition was 21% at posttest, 33% at 6-week FU and 65% at 1-year FU. Mixed-model repeated measures regression identified large short-term reductions in all measures of primary symptoms (d = 1.9±0.2 to d = 1.2±0.2; P<.001), which sustained up to one year after treatment. At posttest, rates of reliable improvement and recovery were 71% and 52% in the completer sample (full sample: 55%/40%). Patient satisfaction was high. Conclusions Results suggest that online therapist-assisted CBT may be as effective in routine practice as it is in clinical trials. Although pre-treatment withdrawal and long-term outcomes require further study, results warrant

An Enzymatic Clinical Chemistry Laboratory Experiment Incorporating an Introduction to Mathematical Method Comparison Techniques

ERIC Educational Resources Information Center

Duxbury, Mark

2004-01-01

An enzymatic laboratory experiment based on the analysis of serum is described that is suitable for students of clinical chemistry. The experiment incorporates an introduction to mathematical method-comparison techniques in which three different clinical glucose analysis methods are compared using linear regression and Bland-Altman difference…

Merging clinical chemistry biomarker data with a COPD database - building a clinical infrastructure for proteomic studies.

PubMed

Eriksson, Jonatan; Andersson, Simone; Appelqvist, Roger; Wieslander, Elisabet; Truedsson, Mikael; Bugge, May; Malm, Johan; Dahlbäck, Magnus; Andersson, Bo; Fehniger, Thomas E; Marko-Varga, György

2016-01-01

Data from biological samples and medical evaluations plays an essential part in clinical decision making. This data is equally important in clinical studies and it is critical to have an infrastructure that ensures that its quality is preserved throughout its entire lifetime. We are running a 5-year longitudinal clinical study, KOL-Örestad, with the objective to identify new COPD (Chronic Obstructive Pulmonary Disease) biomarkers in blood. In the study, clinical data and blood samples are collected from both private and public health-care institutions and stored at our research center in databases and biobanks, respectively. The blood is analyzed by Mass Spectrometry and the results from this analysis then linked to the clinical data. We built an infrastructure that allows us to efficiently collect and analyze the data. We chose to use REDCap as the EDC (Electronic Data Capture) tool for the study due to its short setup-time, ease of use, and flexibility. REDCap allows users to easily design data collection modules based on existing templates. In addition, it provides two functions that allow users to import batches of data; through a web API (Application Programming Interface) as well as by uploading CSV-files (Comma Separated Values). We created a software, DART (Data Rapid Translation), that translates our biomarker data into a format that fits REDCap's CSV-templates. In addition, DART is configurable to work with many other data formats as well. We use DART to import our clinical chemistry data to the REDCap database. We have shown that a powerful and internationally adopted EDC tool such as REDCap can be extended so that it can be used efficiently in proteomic studies. In our study, we accomplish this by using DART to translate our clinical chemistry data to a format that fits the templates of REDCap.

Evaluation of an Instructional Model to Teach Clinically Relevant Medicinal Chemistry in a Campus and a Distance Pathway

PubMed Central

Galt, Kimberly A.

2008-01-01

Objectives To evaluate an instructional model for teaching clinically relevant medicinal chemistry. Methods An instructional model that uses Bloom's cognitive and Krathwohl's affective taxonomy, published and tested concepts in teaching medicinal chemistry, and active learning strategies, was introduced in the medicinal chemistry courses for second-professional year (P2) doctor of pharmacy (PharmD) students (campus and distance) in the 2005-2006 academic year. Student learning and the overall effectiveness of the instructional model were assessed. Student performance after introducing the instructional model was compared to that in prior years. Results Student performance on course examinations improved compared to previous years. Students expressed overall enthusiasm about the course and better understood the value of medicinal chemistry to clinical practice. Conclusion The explicit integration of the cognitive and affective learning objectives improved student performance, student ability to apply medicinal chemistry to clinical practice, and student attitude towards the discipline. Testing this instructional model provided validation to this theoretical framework. The model is effective for both our campus and distance-students. This instructional model may also have broad-based applications to other science courses. PMID:18483599

Screening Breast MRI Outcomes in Routine Clinical Practice: Comparison to BI-RADS Benchmarks.

PubMed

Strigel, Roberta M; Rollenhagen, Jennifer; Burnside, Elizabeth S; Elezaby, Mai; Fowler, Amy M; Kelcz, Frederick; Salkowski, Lonie; DeMartini, Wendy B

2017-04-01

The BI-RADS Atlas 5th Edition includes screening breast magnetic resonance imaging (MRI) outcome benchmarks. However, the metrics are from expert practices and clinical trials of women with hereditary breast cancer predispositions, and it is unknown if they are appropriate for routine practice. We evaluated screening breast MRI audit outcomes in routine practice across a spectrum of elevated risk patients. This Institutional Review Board-approved, Health Insurance Portability and Accountability Act-compliant retrospective study included all consecutive screening breast MRI examinations from July 1, 2010 to June 30, 2013. Examination indications were categorized as gene mutation carrier (GMC), personal history (PH) breast cancer, family history (FH) breast cancer, chest radiation, and atypia/lobular carcinoma in situ (LCIS). Outcomes were determined by pathology and/or ≥12 months clinical and/or imaging follow-up. We calculated abnormal interpretation rate (AIR), cancer detection rate (CDR), positive predictive value of recommendation for tissue diagnosis (PPV2) and biopsy performed (PPV3), and median size and percentage of node-negative invasive cancers. Eight hundred and sixty examinations were performed in 566 patients with a mean age of 47 years. Indications were 367 of 860 (42.7%) FH, 365 of 860 (42.4%) PH, 106 of 860 (12.3%) GMC, 14 of 860 (1.6%) chest radiation, and 8 of 22 (0.9%) atypia/LCIS. The AIR was 134 of 860 (15.6%). Nineteen cancers were identified (13 invasive, 4 DCIS, two lymph nodes), resulting in CDR of 19 of 860 (22.1 per 1000), PPV2 of 19 of 88 (21.6%), and PPV3 of 19 of 80 (23.8%). Of 13 invasive breast cancers, median size was 10 mm, and 8 of 13 were node negative (61.5%). Performance outcomes of screening breast MRI in routine clinical practice across a spectrum of elevated risk patients met the American College of Radiology Breast Imaging Reporting and Data System benchmarks, supporting broad application of these metrics. The indication

Screening Breast MRI Outcomes in Routine Clinical Practice: Comparison to BI-RADS Benchmarks

PubMed Central

Strigel, Roberta M.; Rollenhagen, Jennifer; Burnside, Elizabeth S.; Elezaby, Mai; Fowler, Amy M.; Kelcz, Frederick; Salkowski, Lonie; DeMartini, Wendy B.

2017-01-01

Rationale and Objectives The BI-RADS Atlas 5th Edition includes screening breast magnetic resonance imaging (MRI) outcome benchmarks. However, the metrics are from expert practices and clinical trials of women with hereditary breast cancer predispositions, and it is unknown if they are appropriate for routine practice. We evaluated screening breast MRI audit outcomes in routine practice across a spectrum of elevated risk patients. Materials and Methods This Institutional Review Board-approved, Health Insurance Portability and Accountability Act-compliant retrospective study included all consecutive screening breast MRI examinations from July 1, 2010 to June 30, 2013. Examination indications were categorized as gene mutation carrier (GMC), personal history (PH) breast cancer, family history (FH) breast cancer, chest radiation, and atypia/lobular carcinoma in situ (LCIS). Outcomes were determined by pathology and/or ≥12 months clinical and/or imaging follow-up. We calculated abnormal interpretation rate (AIR), cancer detection rate (CDR), positive predictive value of recommendation for tissue diagnosis (PPV2) and biopsy performed (PPV3), and median size and percentage of node-negative invasive cancers. Results Eight hundred and sixty examinations were performed in 566 patients with a mean age of 47 years. Indications were 367 of 860 (42.7%) FH, 365 of 860 (42.4%) PH, 106 of 860 (12.3%) GMC, 14 of 860 (1.6%) chest radiation, and 8 of 22 (0.9%) atypia/LCIS. The AIR was 134 of 860 (15.6%). Nineteen cancers were identified (13 invasive, 4 DCIS, two lymph nodes), resulting in CDR of 19 of 860 (22.1 per 1000), PPV2 of 19 of 88 (21.6%), and PPV3 of 19 of 80 (23.8%). Of 13 invasive breast cancers, median size was 10 mm, and 8 of 13 were node negative (61.5%). Conclusions Performance outcomes of screening breast MRI in routine clinical practice across a spectrum of elevated risk patients met the American College of Radiology Breast Imaging Reporting and Data System

Avian plasma chemistry analysis using diluted samples.

PubMed

Waldoch, Jennifer; Wack, Raymund; Christopher, Mary

2009-12-01

Clinical chemistry tests are essential for the diagnosis and monitoring of disease in birds. The small volume of blood that can be obtained from many avian species limits the use of routine in-house chemistry analyzers. The aim of this study was to examine the accuracy and precision of avian plasma chemistry values obtained by use of a benchtop analyzer in samples diluted with sterile water, as compared with undiluted samples. Whole blood samples were collected from 13 clinically healthy thick-billed parrots (Rhynchopsitta pachyrhyncha). The samples were placed in lithium heparin tubes and centrifuged and the plasma decanted. One aliquot was analyzed immediately using a VetScan benchtop analyzer with an avian-reptile-specific rotor that included 12 analytes. The remainder of the plasma was divided into two aliquots and stored at -80 degrees C until analysis. One of these aliquots was diluted 1:1, 1:1.5, 1:2, and 1:2.5 with sterile water to give final dilutions of 1:2, 1:2.5, 1:3, and 1:3.5, respectively. The other aliquot was pooled with the 12 other samples to create a plasma pool. The undiluted plasma pool and two final dilutions (1:2 and 1:3) of the pooled plasma were analyzed in replicate (n = 20) to determine intra- and interassay imprecision. Each dilution was analyzed using the avian-reptile rotor and the results multiplied by the appropriate dilution factor to obtain the final result. Significant differences were observed in clinical chemistry results obtained from diluted plasma samples for all analytes except aspartate aminotransferase, creatine kinase, and glucose. Uric acid concentration was not significantly different at dilutions of up to 1:3. Bile acids, globulins, and sodium concentrations were below the limit of detection in all diluted samples and were not statistically analyzed. Based on these results, dilution with sterile water is not recommended for biochemical analysis of avian plasma using the VetScan benchtop analyzer.

Design, Development, and Psychometric Analysis of a General, Organic, and Biological Chemistry Topic Inventory Based on the Identified Main Chemistry Topics Relevant to Nursing Clinical Practice

ERIC Educational Resources Information Center

Brown, Corina E.

2013-01-01

This two-stage study focused on the undergraduate nursing course that covers topics in general, organic, and biological (GOB) chemistry. In the first stage, the central objective was to identify the main concepts of GOB chemistry relevant to the clinical practice of nursing. The collection of data was based on open-ended interviews of both nursing…

Comprehensive reference ranges for hematology and clinical chemistry laboratory parameters derived from normal Nigerian adults.

PubMed

Miri-Dashe, Timzing; Osawe, Sophia; Tokdung, Monday; Daniel, Monday Tokdung Nenbammun; Daniel, Nenbammun; Choji, Rahila Pam; Mamman, Ille; Deme, Kurt; Damulak, Dapus; Abimiku, Alash'le

2014-01-01

Interpretation of laboratory test results with appropriate diagnostic accuracy requires reference or cutoff values. This study is a comprehensive determination of reference values for hematology and clinical chemistry in apparently healthy voluntary non-remunerated blood donors and pregnant women. Consented clients were clinically screened and counseled before testing for HIV, Hepatitis B, Hepatitis C and Syphilis. Standard national blood donors' questionnaire was administered to consented blood donors. Blood from qualified volunteers was used for measurement of complete hematology and chemistry parameters. Blood samples were analyzed from a total of 383 participants, 124 (32.4%) males, 125 (32.6%) non-pregnant females and 134 pregnant females (35.2%) with a mean age of 31 years. Our results showed that the red blood cells count (RBC), Hemoglobin (HB) and Hematocrit (HCT) had significant gender difference (p = 0.000) but not for total white blood count (p>0.05) which was only significantly higher in pregnant verses non-pregnant women (p = 0.000). Hemoglobin and Hematocrit values were lower in pregnancy (P = 0.000). Platelets were significantly higher in females than men (p = 0.001) but lower in pregnant women (p =  .001) with marked difference in gestational period. For clinical chemistry parameters, there was no significant difference for sodium, potassium and chloride (p>0.05) but gender difference exists for Bicarbonate (HCO3), Urea nitrogen, Creatinine as well as the lipids (p<0.05). Total bilirubin was significantly higher in males than females (p = 0.000). Significant differences exist for all chemistry parameters between pregnant and non-pregnant women in this study (p<0.05), except Amylase and total cholesterol (p>0.05). Hematological and Clinical Chemistry reference ranges established in this study showed significant gender differences. Pregnant women also differed from non-pregnant females and during pregnancy. This is the first of such comprehensive

Design and Validation of a Radio-Frequency Identification-Based Device for Routinely Assessing Gait Speed in a Geriatrics Clinic.

PubMed

Barry, Lisa C; Hatchman, Laura; Fan, Zhaoyan; Guralnik, Jack M; Gao, Robert X; Kuchel, George A

2018-05-01

To evaluate the feasibility, acceptability, and validity of a radio-frequency identification (RFID)-based system to measure gait speed in a clinical setting as a first step to using unobtrusive gait speed assessment in routine clinical care. Feasibility study comparing gait speed assessed using an RFID-based system with gait speed assessed using handheld stopwatch, the criterion standard. Outpatient geriatrics clinic at a Connecticut-based academic medical center. Clinic attendees who could walk independently with or without an assistive device (N=50) and healthcare providers (N=9). Gait speed was measured in twice using 2 methods each time before participants entered an examination room. Participants walked at their usual pace while gait speed was recorded simultaneously using the RFID-based system and a handheld stopwatch operated by a trained study investigator. After 2 trials, participants completed a brief survey regarding their experience. At the end of the study period, clinic healthcare providers completed a separate survey. Test-retest reliability of the RFID-based system was high (intraclass correlation coefficient = 0.953). The mean difference ± standard deviation in gait speed between the RFID-based system and the stopwatch was -0.003±0.035 m/s (p=.53) and did not differ significantly according to age, sex, or use of an assistive walking aid. Acceptability of the device was high, and 8 of 9 providers indicated that measuring gait speed using the RFID-based system should be a part of routine clinical care. RFID technology may offer a practical means of overcoming barriers to routine measurement of gait speed in real-world outpatient clinical settings. © 2018, Copyright the Authors Journal compilation © 2018, The American Geriatrics Society.

Reproducibility of Alzheimer’s Disease Cerebrospinal Fluid-Biomarker Measurements under Clinical Routine Conditions

PubMed Central

Vogelgsang, Jonathan; Wedekind, Dirk; Bouter, Caroline; Klafki, Hans-W.; Wiltfang, Jens

2018-01-01

Analysis of cerebrospinal fluid (CSF) is one of the key tools for the state-of-the-art differential diagnosis of dementias. Dementia due to Alzheimer’s disease (AD) is characterized by elevated CSF levels of total Tau (tTau) and phospho-181-Tau (pTau) and low CSF amyloid-β42 (Aβ42). Discrepancies in the laboratory analysis of human materials are well known and much effort has been put into harmonization procedures. In this study, we measured CSF biomarkers of more than 100 patients obtained under clinical routine conditions in two different clinical laboratories. The CSF biomarker levels obtained from the two different sites were significantly correlated: R2 = 0.7129 (tTau, p < 0.001), 0.7914 (pTau, p < 0.001), 0.5078 (Aβ42, p < 0.001), 0.5739 (Aβ40, p < 0.001), and 0.4308 (Aβ42/40, p < 0.001). However, the diagnostic classifications of the Aβ42, tTau, and pTau levels of identical subjects into normal versus pathological range made by the two different sites showed substantial discrepancies (31.5%, 29.6%, and 25.0% discordant cases, respectively). Applying Aβ42/40, instead of CSF Aβ42 alone, lead to a reduction of the discordant cases to 16.8%. Our findings suggest that CSF Aβ42/40 can outperform Aβ42 as a biomarker for AD neuropathology, not only under well-controlled study conditions but also in real life clinical routine. Thus, we recommend the inclusion of Aβ42/40 as a CSF biomarker in the diagnostic procedure. PMID:29439341

Cost Effectiveness Analysis of Clinically Driven versus Routine Laboratory Monitoring of Antiretroviral Therapy in Uganda and Zimbabwe

PubMed Central

Medina Lara, Antonieta; Kigozi, Jesse; Amurwon, Jovita; Muchabaiwa, Lazarus; Nyanzi Wakaholi, Barbara; Mujica Mota, Ruben E.; Walker, A. Sarah; Kasirye, Ronnie; Ssali, Francis; Reid, Andrew; Grosskurth, Heiner; Babiker, Abdel G.; Kityo, Cissy; Katabira, Elly; Munderi, Paula; Mugyenyi, Peter; Hakim, James; Darbyshire, Janet; Gibb, Diana M.; Gilks, Charles F.

2012-01-01

Background Despite funding constraints for treatment programmes in Africa, the costs and economic consequences of routine laboratory monitoring for efficacy and toxicity of antiretroviral therapy (ART) have rarely been evaluated. Methods Cost-effectiveness analysis was conducted in the DART trial (ISRCTN13968779). Adults in Uganda/Zimbabwe starting ART were randomised to clinically-driven monitoring (CDM) or laboratory and clinical monitoring (LCM); individual patient data on healthcare resource utilisation and outcomes were valued with primary economic costs and utilities. Total costs of first/second-line ART, routine 12-weekly CD4 and biochemistry/haematology tests, additional diagnostic investigations, clinic visits, concomitant medications and hospitalisations were considered from the public healthcare sector perspective. A Markov model was used to extrapolate costs and benefits 20 years beyond the trial. Results 3316 (1660LCM;1656CDM) symptomatic, immunosuppressed ART-naive adults (median (IQR) age 37 (32,42); CD4 86 (31,139) cells/mm3) were followed for median 4.9 years. LCM had a mean 0.112 year (41 days) survival benefit at an additional mean cost of $765 [95%CI:685,845], translating into an adjusted incremental cost of $7386 [3277,dominated] per life-year gained and $7793 [4442,39179] per quality-adjusted life year gained. Routine toxicity tests were prominent cost-drivers and had no benefit. With 12-weekly CD4 monitoring from year 2 on ART, low-cost second-line ART, but without toxicity monitoring, CD4 test costs need to fall below $3.78 to become cost-effective (<3xper-capita GDP, following WHO benchmarks). CD4 monitoring at current costs as undertaken in DART was not cost-effective in the long-term. Conclusions There is no rationale for routine toxicity monitoring, which did not affect outcomes and was costly. Even though beneficial, there is little justification for routine 12-weekly CD4 monitoring of ART at current test costs in low-income African

A point-of-care chemistry test for reduction of turnaround and clinical decision time.

PubMed

Lee, Eui Jung; Shin, Sang Do; Song, Kyoung Jun; Kim, Seong Chun; Cho, Jin Seong; Lee, Seung Chul; Park, Ju Ok; Cha, Won Chul

2011-06-01

Our study compared clinical decision time between patients managed with a point-of-care chemistry test (POCT) and patients managed with the traditional central laboratory test (CLT). This was a randomized controlled multicenter trial in the emergency departments (EDs) of 5 academic teaching hospitals. We randomly assigned patients to POCT or CLT stratified by the Emergency Severity Index. A POCT chemistry analyzer (Piccolo; Abaxis, Inc, Union City, Calif), which is able to test liver panel, renal panel, pancreas enzymes, lipid panel, electrolytes, and blood gases, was set up in each ED. Primary and secondary end point was turnaround time and door-to-clinical-decision time. The total 2323 patients were randomly assigned to the POCT group (n = 1167) or to the CLT group (n = 1156). All of the basic characteristics were similar in the 2 groups. The turnaround time (median, interquartile range [IQR]) of the POCT group was shorter than that of the CLT group (14, 12-19 versus 55, 45-69 minutes; P < .0001). The median (IQR) door-to-clinical-decision time was also shorter in the POCT compared with the CLT group (46, 33-61 versus 86, 68-107 minutes; P < .0001). The proportion of patients who had new decisions within 60 minutes was 72.8% for the POCT group and 12.5% for the CLT group (P < .0001). A POCT chemistry analyzer in the ED shortens the test turnaround and ED clinical decision times compared with CLT. Copyright © 2011 Elsevier Inc. All rights reserved.

Chemistry and haematology sample rejection and clinical impact in a tertiary laboratory in Cape Town.

PubMed

Jacobsz, Lourens A; Zemlin, Annalise E; Roos, Mark J; Erasmus, Rajiv T

2011-10-14

Recent publications report that up to 70% of total laboratory errors occur in the pre-analytical phase. Identification of specific problems highlights pre-analytic processes susceptible to errors. The rejection of unsuitable samples can lead to delayed turnaround time and affect patient care. A retrospective audit was conducted investigating the rejection rate of routine blood specimens received at chemistry and haematology laboratories over a 2-week period. The reasons for rejection and potential clinical impact of these rejections were investigated. Thirty patient files were randomly selected and examined to assess the impact of these rejections on clinical care. A total of 32,910 specimens were received during the study period, of which 481 were rejected, giving a rejection rate of 1.46%. The main reasons for rejection were inappropriate clotting (30%) and inadequate sample volume (22%). Only 51.7% of rejected samples were repeated and the average time for a repeat sample to reach the laboratory was about 5 days (121 h). Of the repeated samples, 5.1% had results within critical values. Examination of patient folders showed that in 40% of cases the rejection of samples had an impact on patient care. The evaluation of pre-analytical processes in the laboratory, with regard to sample rejection, allowed one to identify problem areas where improvement is necessary. Rejected samples due to factors out of the laboratory's control had a definite impact on patient care and can thus affect customer satisfaction. Clinicians should be aware of these factors to prevent such rejections.

A roadmap to defining the clinical reportable ranges of chemistry analytes: Increasing automation efficiency and decreasing manual dilutions.

PubMed

Lo, Sheng-Ying; Baird, Geoffrey S; Greene, Dina N

2015-12-07

Proper utilization of resources is an important operational objective for clinical laboratories. To reduce unnecessary manual interventions on automated instruments, we conducted a workflow analysis that optimized dilution parameters and reporting of abnormally high chemistry results for the Beckman AU series of chemistry analyzers while maintaining clinically acceptable reportable ranges. Workflow analysis for the Beckman AU680/5812 and DxC800 chemistry analyzers was performed using historical data. Clinical reportable ranges for 53 chemistry analytes were evaluated. Optimized dilution parameters and upper limit of reportable ranges for the AU680/5812 instruments were derived and validated to meet these reportable ranges. The number of specimens that required manual dilutions before and after optimization was determined for both the AU680/5812 and DxC800, with the DxC800 serving as the reference instrument. Retrospective data analysis revealed that 7700 specimens required manual dilutions on the DxC over a 2-y period. Using our optimized AU-specific dilution and reporting parameters, the data-driven simulation analysis showed a 61% reduction in manual dilutions. For the specimens that required manual dilutions on the AU680/5812, we developed standardized dilution procedures to further streamline workflow. We provide a data-driven, practical outline for clinical laboratories to efficiently optimize their use of automated chemistry analyzers. The outcomes can be used to assist laboratories wishing to improve their existing procedures or to facilitate transitioning into a new line of instrumentation, regardless of the instrument model or manufacturer. Copyright © 2015 Elsevier B.V. All rights reserved.

Rotigotine transdermal patch in combination therapy for Parkinson's disease--observations in routine clinical practice.

PubMed

Ceballos-Baumann, Andres; Häck, Hermann-Josef

2011-10-01

The dopamine agonist rotigotine has shown efficacy and safety for the treatment of early and advanced Parkinson's disease (PD) in controlled clinical trials. This observational study evaluated rotigotine administration in combination with other antiparkinsonian medication in routine clinical practice. Data were collected by 688 German practice-based neurologists, initiating rotigotine treatment in patients with idiopathic Parkinson's disease. Assessments included rotigotine maintenance dose, changes in concomitant PD medication, changes in sleep quality, and rotigotine tolerability over an observation period of 12-16 weeks. The median rotigotine maintenance dose was 6 mg/24 h (n = 969, full analysis set). The proportion of all other prescribed PD medications declined over the observation period; combination therapy decreased by 18.7%. Daily levodopa intake was markedly reduced by 87 mg (18.9%) in 47.6% of the patients with levodopa documentation; 7% no longer required levodopa after 12-16 weeks. Mean overall sleep quality (PD Sleep Scale item 1) improved by 21.4 points, the occurrence of nocturias (PDSS item 8) by 13.4 points, and 'turning in bed' (Unified Parkinson's Disease Rating Scale part II) by 0.6 points. Drug-related adverse events were reported for 7.9% of all patients (n = 1152, safety population). Application site reactions were the most common adverse events (2.2%) resulting in early discontinuation in 1.4% of patients. In routine clinical practice, treatment initiation with rotigotine transdermal patch was associated with a reduction of other prescribed PD medications and with an improvement of self-reported sleep quality.

Relationships between acid deposition, watershed characteristics, and stream chemistry in Maryland's coastal plain. Final report. Volume 5. Appendix B. 4

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

Campbell, S.; Bartoshesky, J.; Heimbuch, D.

1987-06-01

Contents include: data quality assurance and stream, precipitation, and meteorological data; Granny Finley Branch stream chemistry (routine sampling, storm-event chemistry, longitudinal sampling, groundwater chemistry).

Therapeutic Plasma Exchange Decreases Levels of Routinely Used Cardiac and Inflammatory Biomarkers

PubMed Central

Beutel, Gernot; Bauersachs, Johann; David, Sascha; Schmidt, Bernhard M. W.; Lichtinghagen, Ralf; Kielstein, Jan T.

2012-01-01

Background Therapeutic plasma exchange (TPE) plays a key role in the management of various diseases, from thrombotic thrombocytopenic purpura and Goodpasture's syndrome to cardiac allograft rejection. In many of these disease states cardiac and inflammatory involvement is common and biomarkers are routinely used for diagnosis or assessment of therapeutic success. The effect of TPE on biomarkers used in the clinical routine has not been investigated. Methods TPE was initiated for established clinical conditions in 21 patients. Troponin T, NT-proBNP, C-reactive protein, procalcitonin and routine chemistry were drawn before and after TPE, as well as before and after the 2nd TPE. The total amount of these markers in the waste bag was also analyzed. Results In 21 patients 42 TPEs were performed. The procedure reduced plasma levels of the examined biomarkers: 23% for NT-proBNP (pre vs. post: 4637±10234 ng/l to 3565±8295 ng/l, p<0.001), 64% for CRP (21.9±47.0 mg/l vs. 7.8±15.8 mg/l, p<0.001) and 31% for procalcitonin (0.39±1.1 µg/l vs. 0.27±0.72 µg/l, p=0.004). TPE also tended to reduce plasma levels of troponin T by about 14% (60.7±175.5 ng/l vs. 52.2±141.3 ng/l), however this difference was not statistical significant (p=0.95). There was a significant correlation between the difference of pre TPE levels to post TPE levels of all examined biomarkers and the total amount of the removed biomarker in the collected removed plasma. Conclusions TPE significantly reduces plasma levels of inflammatory and cardiac biomarkers. Therefore, post TPE levels of cardiac and inflammatory biomarkers should be viewed with caution. PMID:22685586

Selected clinical chemistry analytes correlate with the pathogenesis of inclusion body hepatitis experimentally induced by fowl aviadenoviruses.

PubMed

Matos, Miguel; Grafl, Beatrice; Liebhart, Dieter; Schwendenwein, Ilse; Hess, Michael

2016-10-01

In the present study, clinical chemistry was applied to assess the pathogenesis and progression of experimentally induced inclusion body hepatitis (IBH). For this, five fowl aviadenovirus (FAdV) strains from recent IBH field outbreaks were used to orally inoculate different groups of day-old specific pathogen-free chickens, which were weighed, sampled and examined during necropsy by sequential killing. Mortalities of 50% and 30% were recorded in two groups between 6 and 9 days post-infection (dpi), along with a decreased weight of 23% and 20%, respectively, compared to the control group. Macroscopical changes were seen in the liver and kidney between 6 and 10 dpi, with no lesions being observed in the other organs. Histological lesions were observed in the liver and pancreas during the same period. Plasma was collected from killed birds of each group at each time point and the following clinical chemistry analytes were investigated: aspartate aminotransferase (AST), glutamate dehydrogenase (GLDH), bile acids, total protein, albumin, uric acid and lipase. Plasma protein profile, AST and GLDH, together with bile acids values paralleled the macroscopical and histopathological lesions in the liver, while plasma lipase activity levels coincided with lesions observed in pancreas. In agreement with the histology and clinical chemistry, viral load in the target organs, liver and pancreas, was highest at 7 dpi. Thus, clinical chemistry was found to be a valuable tool in evaluating and monitoring the progression of IBH in experimentally infected birds, providing a deeper knowledge of the underlying pathophysiological mechanisms of a FAdV infection in chickens.

Modifying the Clinical Outcomes in Routine Evaluation Measure for Use with People Who Have a Learning Disability

ERIC Educational Resources Information Center

Marshall, Keith; Willoughby-Booth, Simon

2007-01-01

There are few reliable self-report measures suitable for people with a learning disability in reporting psychological distress. This study examines the modification of the Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM), exploring its reliability, using two different presentation styles. One style included a sequencing task then…

Gene expression profiling in multiple myeloma--reporting of entities, risk, and targets in clinical routine.

PubMed

Meissner, Tobias; Seckinger, Anja; Rème, Thierry; Hielscher, Thomas; Möhler, Thomas; Neben, Kai; Goldschmidt, Hartmut; Klein, Bernard; Hose, Dirk

2011-12-01

Multiple myeloma is an incurable malignant plasma cell disease characterized by survival ranging from several months to more than 15 years. Assessment of risk and underlying molecular heterogeneity can be excellently done by gene expression profiling (GEP), but its way into clinical routine is hampered by the lack of an appropriate reporting tool and the integration with other prognostic factors into a single "meta" risk stratification. The GEP-report (GEP-R) was built as an open-source software developed in R for gene expression reporting in clinical practice using Affymetrix microarrays. GEP-R processes new samples by applying a documentation-by-value strategy to the raw data to be able to assign thresholds and grouping algorithms defined on a reference cohort of 262 patients with multiple myeloma. Furthermore, we integrated expression-based and conventional prognostic factors within one risk stratification (HM-metascore). The GEP-R comprises (i) quality control, (ii) sample identity control, (iii) biologic classification, (iv) risk stratification, and (v) assessment of target genes. The resulting HM-metascore is defined as the sum over the weighted factors gene expression-based risk-assessment (UAMS-, IFM-score), proliferation, International Staging System (ISS) stage, t(4;14), and expression of prognostic target genes (AURKA, IGF1R) for which clinical grade inhibitors exist. The HM-score delineates three significantly different groups of 13.1%, 72.1%, and 14.7% of patients with a 6-year survival rate of 89.3%, 60.6%, and 18.6%, respectively. GEP reporting allows prospective assessment of risk and target gene expression and integration of current prognostic factors in clinical routine, being customizable about novel parameters or other cancer entities. ©2011 AACR.

Clinical decision making and outcome in routine care for people with severe mental illness (CEDAR): study protocol.

PubMed

Puschner, Bernd; Steffen, Sabine; Slade, Mike; Kaliniecka, Helena; Maj, Mario; Fiorillo, Andrea; Munk-Jørgensen, Povl; Larsen, Jens Ivar; Egerházi, Anikó; Nemes, Zoltan; Rössler, Wulf; Kawohl, Wolfram; Becker, Thomas

2010-11-10

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

Error identification in a high-volume clinical chemistry laboratory: Five-year experience.

PubMed

Jafri, Lena; Khan, Aysha Habib; Ghani, Farooq; Shakeel, Shahid; Raheem, Ahmed; Siddiqui, Imran

2015-07-01

Quality indicators for assessing the performance of a laboratory require a systematic and continuous approach in collecting and analyzing data. The aim of this study was to determine the frequency of errors utilizing the quality indicators in a clinical chemistry laboratory and to convert errors to the Sigma scale. Five-year quality indicator data of a clinical chemistry laboratory was evaluated to describe the frequency of errors. An 'error' was defined as a defect during the entire testing process from the time requisition was raised and phlebotomy was done until the result dispatch. An indicator with a Sigma value of 4 was considered good but a process for which the Sigma value was 5 (i.e. 99.977% error-free) was considered well controlled. In the five-year period, a total of 6,792,020 specimens were received in the laboratory. Among a total of 17,631,834 analyses, 15.5% were from within hospital. Total error rate was 0.45% and of all the quality indicators used in this study the average Sigma level was 5.2. Three indicators - visible hemolysis, failure of proficiency testing and delay in stat tests - were below 5 on the Sigma scale and highlight the need to rigorously monitor these processes. Using Six Sigma metrics quality in a clinical laboratory can be monitored more effectively and it can set benchmarks for improving efficiency.

Routine Responses to Disruption of Routines

ERIC Educational Resources Information Center

Guha, Mahua

2015-01-01

"Organisational routines" is a widely studied research area. However, there is a dearth of research on disruption of routines. The few studies on disruption of routines discussed problem-solving activities that are carried out in response to disruption. In contrast, this study develops a theory of "solution routines" that are a…

Population Pharmacokinetics of Intravenous Methotrexate in Patients with Hematological Malignancies: Utilization of Routine Clinical Monitoring Parameters.

PubMed

Nader, Ahmed; Zahran, Noran; Alshammaa, Aya; Altaweel, Heba; Kassem, Nancy; Wilby, Kyle John

2017-04-01

Clinical response to methotrexate in cancer is variable and depends on several factors including serum drug exposure. This study aimed to develop a population pharmacokinetic model describing methotrexate disposition in cancer patients using retrospective chart review data available from routine clinical practice. A retrospective review of medical records was conducted for cancer patients in Qatar. Relevant data (methotrexate dosing/concentrations from multiple occasions, patient history, and laboratory values) were extracted and analyzed using NONMEM VII ® . A population pharmacokinetic model was developed and used to estimate inter-individual and inter-occasion variability terms on methotrexate pharmacokinetic parameters, as well as patient factors affecting methotrexate pharmacokinetics. Methotrexate disposition was described by a two-compartment model with clearance (CL) of 15.7 L/h and central volume of distribution (V c ) of 79.2 L. Patient weight and hematocrit levels were significant covariates on methotrexate V c and CL, respectively. Methotrexate CL changed by 50 % with changes in hematocrit levels from 23 to 50 %. Inter-occasion variability in methotrexate CL was estimated for patients administered the drug on multiple occasions (48 and 31 % for 2nd and 3rd visits, respectively). Therapeutic drug monitoring data collected during routine clinical practice can provide a useful tool for understanding factors affecting methotrexate pharmacokinetics. Patient weight and hematocrit levels may play a clinically important role in determining methotrexate serum exposure and dosing requirements. Future prospective studies are needed to validate results of the developed model and evaluate its usefulness to predict methotrexate exposure and optimize dosing regimens.

EC4 European Syllabus for Post-Graduate Training in Clinical Chemistry and Laboratory Medicine: version 3 - 2005.

PubMed

Zerah, Simone; McMurray, Janet; Bousquet, Bernard; Baum, Hannsjorg; Beastall, Graham H; Blaton, Vic; Cals, Marie-Josèphe; Duchassaing, Danielle; Gaudeau-Toussaint, Marie-Françoise; Harmoinen, Aimo; Hoffmann, Hans; Jansen, Rob T; Kenny, Desmond; Kohse, Klaus P; Köller, Ursula; Gobert, Jean-Gérard; Linget, Christine; Lund, Erik; Nubile, Giuseppe; Opp, Matthias; Pazzagli, Mario; Pinon, Georges; Queralto, José M; Reguengo, Henrique; Rizos, Demetrios; Szekeres, Thomas; Vidaud, Michel; Wallinder, Hans

2006-01-01

The EC4 Syllabus for Postgraduate Training is the basis for the European Register of Specialists in Clinical Chemistry and Laboratory Medicine. The syllabus: Indicates the level of requirements in postgraduate training to harmonise the postgraduate education in the European Union (EU); Indicates the level of content of national training programmes to obtain adequate knowledge and experience; Is approved by all EU societies for clinical chemistry and laboratory medicine. The syllabus is not primarily meant to be a training guide, but on the basis of the overview given (common minimal programme), national societies should formulate programmes that indicate where knowledge and experience is needed. The main points of this programme are: Indicates the level of requirements in postgraduate training to harmonise the postgraduate education in the European Union (EU); Indicates the level of content of national training programmes to obtain adequate knowledge and experience; Is approved by all EU societies for clinical chemistry and laboratory medicine. Knowledge in biochemistry, haematology, immunology, etc.; Pre-analytical conditions; Evaluation of results; Interpretations (post-analytical phase); Laboratory management; and Quality insurance management. The aim of this version of the syllabus is to be in accordance with the Directive of Professional Qualifications published on 30 September 2005. To prepare the common platforms planned in this directive, the disciplines are divided into four categories: Indicates the level of requirements in postgraduate training to harmonise the postgraduate education in the European Union (EU); Indicates the level of content of national training programmes to obtain adequate knowledge and experience; Is approved by all EU societies for clinical chemistry and laboratory medicine. Knowledge in biochemistry, haematology, immunology, etc.; Pre-analytical conditions; Evaluation of results; Interpretations (post-analytical phase); Laboratory

Atrial Fibrillation Management Strategies in Routine Clinical Practice: Insights from the International RealiseAF Survey

PubMed Central

Chiang, Chern-En; Naditch-Brûlé, Lisa; Brette, Sandrine; Silva-Cardoso, José; Gamra, Habib; Murin, Jan; Zharinov, Oleg J.; Steg, Philippe Gabriel

2016-01-01

Background Atrial fibrillation (AF) can be managed with rhythm- or rate-control strategies. There are few data from routine clinical practice on the frequency with which each strategy is used and their correlates in terms of patients’ clinical characteristics, AF control, and symptom burden. Methods RealiseAF was an international, cross-sectional, observational survey of 11,198 patients with AF. The aim of this analysis was to describe patient profiles and symptoms according to the AF management strategy used. A multivariate logistic regression identified factors associated with AF management strategy at the end of the visit. Results Among 10,497 eligible patients, 53.7% used a rate-control strategy, compared with 34.5% who used a rhythm-control strategy. In 11.8% of patients, no clear strategy was stated. The proportion of patients with AF-related symptoms (EHRA Class > = II) was 78.1% (n = 4396/5630) for those using a rate-control strategy vs. 67.8% for those using a rhythm-control strategy (p<0.001). Multivariate logistic regression analysis revealed that age <75 years or the paroxysmal or persistent form of AF favored the choice of a rhythm-control strategy. A change in strategy was infrequent, even in patients with European Heart Rhythm Association (EHRA) Class > = II. Conclusions In the RealiseAF routine clinical practice survey, rate control was more commonly used than rhythm control, and a change in strategy was uncommon, even in symptomatic patients. In almost 12% of patients, no clear strategy was stated. Physician awareness regarding optimal management strategies for AF may be improved. PMID:26800084

Developing the public health role of a front line clinical service: integrating stop smoking advice into routine podiatry services.

PubMed

Gray, Jackie; Eden, Gary; Williams, Maria

2007-06-01

Although smoking is a major public health problem, many clinicians do not routinely provide evidence-based health improvement advice to smokers to help them to quit. Plan, Do, Study, Act (PDSA) cycle methodology was used to design and implement a service development so that health improvement advice for smokers featured in all podiatry consultations provided by a Primary Care Trust in North East England. IT systems were developed to record the number and proportion of patients for whom smoking status was assessed, and the number and proportion of smokers who were given advice to quit and referred for specialist support. A questionnaire to staff explored their perceptions of the development on their clinics and consultations. During a 6-month period, smoking status was recorded for all 8831 (100%) patients attending podiatry clinics; 83% of smokers were given brief advice to quit; 7% of smokers were given help to access specialist stop smoking support services. Improvements were introduced within existing budgets and did not prolong clinics. It is straightforward and inexpensive to develop clinical services so that public health guidance is routinely implemented. More widespread implementation of similar service developments could lead to national improvements in public health.

Clinical lead poisoning in England: an analysis of routine sources of data.

PubMed

Elliott, P; Arnold, R; Barltrop, D; Thornton, I; House, I M; Henry, J A

1999-12-01

To examine the occurrence of clinical lead poisoning in England based on routine sources of data. Three routine data sources were examined, over different periods according to availability of data: (a) mortality for England, 1981-96; (b) hospital episode statistics data for England, for the 3 years 1 April 1992-31 March 1995; (c) statutory returns to the Health and Safety Executive under the reporting of injuries, diseases, and dangerous occurrences regulations (RIDDOR), also for the period 1 April 1992-31 March 1995. Also, analyses of blood lead concentrations carried out by the Medical Toxicology Unit, Guy's and St Thomas' Hospital Trust in London during the period 1 January 1991-31 December 1997 were examined. The analyses were performed both for industrial screening purposes and in response to clinicians' requests where lead poisoning was suspected. This is one of several laboratories carrying out such analyses in the United Kingdom. One death, of a 2 year old girl, was coded to lead poisoning in England during 1981-96. Analysis of hospital episode statistics data identified 83 hospital cases (124 admissions) over 3 years with any mention of lead poisoning, excluding two with admissions dating from 1965 and 1969. For these 83 cases the median hospital stay per admission was 3 days (range 0-115 days). Five were coded as having received intravenous treatment. Further clinical details of these cases beyond what is routinely recorded on the hospital episode statistics database were not available, except for blood lead concentrations in cases also identified on the Medical Toxicology Unit database. Eighteen cases (22%) were below 5 years of age of whom 10 (56%) came from the most deprived quintile of electoral wards. There was evidence to suggest spatial clustering of cases (p = 0.02). Six occupational cases were reported under RIDDOR in England during the period of study, two of whom were identified on the hospital episode statistics database. One further

A mixed methods approach to adapting health-related quality of life measures for use in routine oncology clinical practice.

PubMed

Harley, Clare; Takeuchi, Elena; Taylor, Sally; Keding, Ada; Absolom, Kate; Brown, Julia; Velikova, Galina

2012-04-01

The current study reviewed and adapted existing health-related quality of life (HRQoL) instruments for use in routine clinical practice delivering outpatient chemotherapy for colorectal, breast and gynaecological cancers. 564 (288 gynaecological, 208 breast and 68 colorectal) outpatient consultations of 141 patients were audio-recorded and analysed to identify discussed issues. Issues were ranked from most to least commonly discussed within each disease group. Existing HRQoL instruments were evaluated against these lists and best fitting items entered into cancer-specific item banks. Item banks were evaluated during semi-structured interviews by twenty-one oncologists (13 consultants and 8 specialist registrars), four clinical nurse specialists and thirty patients, from breast, gynaecological and colorectal cancer practices. Pilot questionnaires were completed by 448 (145 breast, 148 gynaecological and 155 colorectal) patients attending outpatient clinics. Item selection and scale reliability was explored using descriptive data and psychometric methods alongside qualitative patient and clinician ratings. Each questionnaire includes five physical and three psychosocial function scales each with good internal consistency reliability (α > 0.70) plus disease-specific individual-symptom items identified as useful in clinical practice. Three cancer-specific health-related quality of life measures were developed for use in routine clinical practice. Initial analyses suggest good clinical utility and acceptable psychometric properties for the new instruments.

Arterial Destiffening in Previously Untreated Mild Hypertensives After 1 Year of Routine Clinical Management.

PubMed

Rodilla, Enrique; Millasseau, Sandrine; Costa, Jose Antonio; Pascual, Jose Maria

2017-05-01

Arterial stiffness, measured with pulse wave velocity (PWV), is now classified as a marker of target organ damage (TOD) alongside left ventricular hypertrophy and moderately increased albuminuria. Interventional studies on treated hypertensive patients have shown that PWV could be improved. Our aim was to assess changes in arterial stiffness after 1 year of routine clinical practice in never-treated hypertensive patients. We studied 356 never-treated patients with suspected hypertension. After standard clinical assessment during which presence of TOD was evaluated, hypertension diagnosis was confirmed in 231 subjects who subsequently received standard routine care. Both hypertensive and the 125 controls came back for a follow-up visit after 1 year. Hypertensive patients were slightly older (46 ± 12 vs. 50 ± 12 years, P < 0.001), with higher mean arterial pressure (MAP)-adjusted PWV compared to controls (8.6 ± 2.0 vs. 8.0 ± 1.7 m/s, P < 0.001) and 47% of them presented 1 or more TOD. After 1 year of treatment, MAP was similar in both groups (94.9 vs. 96.2 mm Hg; P = ns), but adjusted PWV remained significantly higher in the hypertensive patients (7.8 ± 1.4 vs. 8.3 ± 1.7 m/s, P = 0.004). The prevalence of elevated PWV was reduced from 20% to 12%. All antihypertensive drugs achieved the same blood pressure (BP) and PWV reduction with the exception of vasodilating beta-blockers which gave slightly better results probably due to heart rate reduction. BP reduction in newly diagnosed hypertensive patients improves arterial stiffness within a year of real-life clinical practice. Patients with the highest PWV and the largest reduction of BP "destiffened" the most whatever antihypertensive class was used. © American Journal of Hypertension, Ltd 2016. All rights reserved. For Permissions, please email: journals.permissions@oup.com

Development and Analysis of an Instrument to Assess Student Understanding of GOB Chemistry Knowledge Relevant to Clinical Nursing Practice

ERIC Educational Resources Information Center

Brown, Corina E.; Hyslop, Richard M.; Barbera, Jack

2015-01-01

The General, Organic, and Biological Chemistry Knowledge Assessment (GOB-CKA) is a multiple-choice instrument designed to assess students' understanding of the chemistry topics deemed important to clinical nursing practice. This manuscript describes the development process of the individual items along with a psychometric evaluation of the…

Clinical chemistry and laboratory medicine in Croatia: regulation of the profession.

PubMed

Simundic, Ana-Maria; Topic, Elizabeta; Cvoriscec, Dubravka; Cepelak, Ivana

2011-01-01

Heterogeneity exists across Europe in the definition of the profession of clinical chemistry and laboratory medicine and also in academic background of specialists in this discipline. This article provides an overview of the standards of education and training of laboratory professionals and quality regulations in Croatia. Clinical chemistry in Croatia is almost exclusively practiced by medical biochemists. Although term Medical biochemist often relates to medical doctors in other European countries, in Croatia medical biochemists are not medical doctors, but university degree professionals who are qualified scientifically. Practicing the medical biochemistry is regulated by The Health Care Law, The Law of the Medical Biochemistry Profession and The Law of the State and Private Health Insurance. According to the law, only medical biochemists are entitled to run and work in the medical biochemistry laboratory. University degree is earned after the 5 years of the studies. Register for medical biochemists is kept by the Croatian Chamber of Medical Biochemists. Licensing is mandatory, valid for 6 years and regulated by the government (Law on the Health Care, 1993). Vocational training for medical biochemists lasts 44 months and is regulated by the national regulatory document issued by the Ministry of Health. Accreditation is not mandatory and is provided by an independent, non-commercial national accreditation body. The profession has interdisciplinary character and a level of required competence and skills comparable to other European countries.

Review of systems, physical examination, and routine tests for case-finding in ambulatory patients.

PubMed

Boland, B J; Wollan, P C; Silverstein, M D

1995-04-01

The screening value of the comprehensive review of systems and the complete physical examination in detecting unsuspected diseases for which therapeutic interventions are initiated has not been formally studied in ambulatory patients. The medical records of 100 randomly selected adult patients who had an ambulatory general medical evaluation at the Mayo Clinic in 1990-1991 were surveyed to compare review of systems and physical examination with routine laboratory tests, chest radiography, and electrocardiography as case-finding maneuvers. The main outcome measure was the therapeutic yield of each case-finding maneuver, defined as the proportion of maneuvers leading to a new therapy for a new clinically important diagnosis. The utilization rate of routine tests in the 100 patients (mean age: 59 +/- 16 years; 58% women) was high, ranging from 77 to 98%. Overall, the case-finding maneuvers led to 36 unsuspected clinically important diagnoses and resulted in 25 new therapeutic interventions. Higher therapeutic yield was observed for review of systems (7%), physical examination (5%), and lipid screening (9.2%) than for chemistry group (2.2%), complete blood count (1.8%), thyroid tests (1.5%), urinalysis (1.1%), electrocardiography (0%), or chest radiography (0%). The number of therapeutic interventions was not associated with patient's age (P = 0.55), sex (P = 0.88), comorbidity (P = 0.30) or with the time interval since the last general medical evaluation (P = 0.12). Based on therapeutic yield, these data suggest that review of systems and physical examination are valuable case-finding maneuvers in the periodic medical evaluation of ambulatory patients.

Clinical and Pharmacogenetic Predictors of Circulating Atorvastatin and Rosuvastatin Concentration in Routine Clinical Care

PubMed Central

DeGorter, Marianne K.; Tirona, Rommel G.; Schwarz, Ute I.; Choi, Yun-Hee; Dresser, George K.; Suskin, Neville; Myers, Kathryn; Zou, GuangYong; Iwuchukwu, Otito; Wei, Wei-Qi; Wilke, Russell A.; Hegele, Robert A.; Kim, Richard B.

2014-01-01

Background A barrier to statin therapy is myopathy associated with elevated systemic drug exposure. Our objective was to examine the association between clinical and pharmacogenetic variables and statin concentrations in patients. Methods and Results In total, 299 patients taking atorvastatin or rosuvastatin were prospectively recruited at an outpatient referral center. The contribution of clinical variables and transporter gene polymorphisms to statin concentration was assessed using multiple linear regression. We observed 45-fold variation in statin concentration among patients taking the same dose. After adjustment for gender, age, body mass index, ethnicity, dose, and time from last dose, SLCO1B1 c.521T>C (p < 0.001) and ABCG2 c.421C>A (p < 0.01) were important to rosuvastatin concentration (adjusted R2 = 0.56 for the final model). Atorvastatin concentration was associated with SLCO1B1 c.388A>G (p < 0.01) and c.521T>C (p < 0.05), and 4β-hydroxycholesterol, a CYP3A activity marker (adjusted R2 = 0.47). A second cohort of 579 patients from primary and specialty care databases were retrospectively genotyped. In this cohort, genotypes associated with statin concentration were not differently distributed among dosing groups, implying providers had not yet optimized each patient's risk-benefit ratio. Nearly 50% of patients in routine practice taking the highest doses were predicted to have statin concentrations greater than the 90th percentile. Conclusions Interindividual variability in statin exposure in patients is associated with uptake and efflux transporter polymorphisms. An algorithm incorporating genomic and clinical variables to avoid high atorvastatin and rosuvastatin levels is described; further study will determine if this approach reduces incidence of statin-myopathy. PMID:23876492

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

PubMed

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

2009-01-01

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

Evaluation of Serum Lipid, Thyroid, and Hepatic Clinical Chemistries in Association With Serum Perfluorooctanesulfonate (PFOS) in Cynomolgus Monkeys After Oral Dosing With Potassium PFOS

PubMed Central

Allen, Bruce C.; Andres, Kara L.; Ehresman, David J.; Falvo, Ria; Provencher, Anne; Olsen, Geary W.; Butenhoff, John L.

2017-01-01

Abstract An oral dose study with perfluorooctanesulfonate (PFOS) was undertaken to identify potential associations between serum PFOS and changes in serum clinical chemistry parameters in purpose-bred young adult cynomolgus monkeys (Macaca fascicularis). In this study, control group (n = 6/sex) was sham-dosed with vehicle (0.5% Tween 20 and 5% ethanol in water), low-dose group (n = 6/sex) received 1 single K+PFOS dose (9 mg/kg), and high-dose group (n = 4–6/sex) received 3 separate K+ PFOS doses (11–17.2 mg/kg). Monkeys were given routine checkups and observed carefully for health problems on a daily basis. Scheduled blood samples were drawn from all monkeys prior to, during, and after K+PFOS administration for up to 1 year and they were analyzed for PFOS concentrations and clinical chemistry markers for coagulation, lipids, hepatic, renal, electrolytes, and thyroid-related hormones. No mortality occurred during the study. All the monkeys were healthy, gained weight, and were released back to the colony at the end of the study. The highest serum PFOS achieved was approximately 165 μg/ml. When compared with time-matched controls, administration of K+PFOS to monkeys did not result in any toxicologically meaningful or clinically relevant changes in serum clinical measurements for coagulation, lipids, hepatic, renal, electrolytes, and thyroid-related hormones. A slight reduction in serum cholesterol (primarily the high-density lipoprotein fraction), although not toxicologically significant, was observed. The corresponding lower-bound fifth percentile benchmark concentrations (BMCL1sd) were 74 and 76 μg/ml for male and female monkeys, respectively. Compared to the 2013–2014 geometric mean serum PFOS level of 4.99 ng/ml (0.00499 μg/ml) in US general population reported by CDC NHANES, this represents 4 orders of magnitude for margin of exposure. PMID:28115654

Interferences from blood collection tube components on clinical chemistry assays

PubMed Central

Bowen, Raffick A.R.; Remaley, Alan T.

2014-01-01

Improper design or use of blood collection devices can adversely affect the accuracy of laboratory test results. Vascular access devices, such as catheters and needles, exert shear forces during blood flow, which creates a predisposition to cell lysis. Components from blood collection tubes, such as stoppers, lubricants, surfactants, and separator gels, can leach into specimens and/or adsorb analytes from a specimen; special tube additives may also alter analyte stability. Because of these interactions with blood specimens, blood collection devices are a potential source of pre-analytical error in laboratory testing. Accurate laboratory testing requires an understanding of the complex interactions between collection devices and blood specimens. Manufacturers, vendors, and clinical laboratorians must consider the pre-analytical challenges in laboratory testing. Although other authors have described the effects of endogenous substances on clinical assay results, the effects/impact of blood collection tube additives and components have not been well systematically described or explained. This review aims to identify and describe blood collection tube additives and their components and the strategies used to minimize their effects on clinical chemistry assays. PMID:24627713

Clinical outcomes and cost effectiveness of accelerated diagnostic protocol in a chest pain center compared with routine care of patients with chest pain.

PubMed

Asher, Elad; Reuveni, Haim; Shlomo, Nir; Gerber, Yariv; Beigel, Roy; Narodetski, Michael; Eldar, Michael; Or, Jacob; Hod, Hanoch; Shamiss, Arie; Matetzky, Shlomi

2015-01-01

The aim of this study was to compare in patients presenting with acute chest pain the clinical outcomes and cost-effectiveness of an accelerated diagnostic protocol utilizing contemporary technology in a chest pain unit versus routine care in an internal medicine department. Hospital and 90-day course were prospectively studied in 585 consecutive low-moderate risk acute chest pain patients, of whom 304 were investigated in a designated chest pain center using a pre-specified accelerated diagnostic protocol, while 281 underwent routine care in an internal medicine ward. Hospitalization was longer in the routine care compared with the accelerated diagnostic protocol group (p<0.001). During hospitalization, 298 accelerated diagnostic protocol patients (98%) vs. 57 (20%) routine care patients underwent non-invasive testing, (p<0.001). Throughout the 90-day follow-up, diagnostic imaging testing was performed in 125 (44%) and 26 (9%) patients in the routine care and accelerated diagnostic protocol patients, respectively (p<0.001). Ultimately, most patients in both groups had non-invasive imaging testing. Accelerated diagnostic protocol patients compared with those receiving routine care was associated with a lower incidence of readmissions for chest pain [8 (3%) vs. 24 (9%), p<0.01], and acute coronary syndromes [1 (0.3%) vs. 9 (3.2%), p<0.01], during the follow-up period. The accelerated diagnostic protocol remained a predictor of lower acute coronary syndromes and readmissions after propensity score analysis [OR = 0.28 (CI 95% 0.14-0.59)]. Cost per patient was similar in both groups [($2510 vs. $2703 for the accelerated diagnostic protocol and routine care group, respectively, (p = 0.9)]. An accelerated diagnostic protocol is clinically superior and as cost effective as routine in acute chest pain patients, and may save time and resources.

Clinical Outcomes and Cost Effectiveness of Accelerated Diagnostic Protocol in a Chest Pain Center Compared with Routine Care of Patients with Chest Pain

PubMed Central

Asher, Elad; Reuveni, Haim; Shlomo, Nir; Gerber, Yariv; Beigel, Roy; Narodetski, Michael; Eldar, Michael; Or, Jacob; Hod, Hanoch; Shamiss, Arie; Matetzky, Shlomi

2015-01-01

Aims The aim of this study was to compare in patients presenting with acute chest pain the clinical outcomes and cost-effectiveness of an accelerated diagnostic protocol utilizing contemporary technology in a chest pain unit versus routine care in an internal medicine department. Methods and Results Hospital and 90-day course were prospectively studied in 585 consecutive low-moderate risk acute chest pain patients, of whom 304 were investigated in a designated chest pain center using a pre-specified accelerated diagnostic protocol, while 281 underwent routine care in an internal medicine ward. Hospitalization was longer in the routine care compared with the accelerated diagnostic protocol group (p<0.001). During hospitalization, 298 accelerated diagnostic protocol patients (98%) vs. 57 (20%) routine care patients underwent non-invasive testing, (p<0.001). Throughout the 90-day follow-up, diagnostic imaging testing was performed in 125 (44%) and 26 (9%) patients in the routine care and accelerated diagnostic protocol patients, respectively (p<0.001). Ultimately, most patients in both groups had non-invasive imaging testing. Accelerated diagnostic protocol patients compared with those receiving routine care was associated with a lower incidence of readmissions for chest pain [8 (3%) vs. 24 (9%), p<0.01], and acute coronary syndromes [1 (0.3%) vs. 9 (3.2%), p<0.01], during the follow-up period. The accelerated diagnostic protocol remained a predictor of lower acute coronary syndromes and readmissions after propensity score analysis [OR = 0.28 (CI 95% 0.14–0.59)]. Cost per patient was similar in both groups [($2510 vs. $2703 for the accelerated diagnostic protocol and routine care group, respectively, (p = 0.9)]. Conclusion An accelerated diagnostic protocol is clinically superior and as cost effective as routine in acute chest pain patients, and may save time and resources. PMID:25622029

The significance of routines in nursing practice.

PubMed

Rytterström, Patrik; Unosson, Mitra; Arman, Maria

2011-12-01

The aim of this study was to illuminate the significance of routines in nursing practice. Clinical nursing is performed under the guidance of routines to varying degrees. In the nursing literature, routine is described as having both negative and positive aspects, but use of the term is inconsistent, and empirical evidence is sparse. In the research on organisational routines, a distinction is made between routine as a rule and routine as action. A qualitative design using a phenomenological-hermeneutic approach. Data collection from three focus groups focused on nurses' experience of routines. Seventeen individual interviews from a previous study focusing on caring culture were also analysed in a secondary qualitative analysis. All participants were employed as 'qualified nursing pool' nurses. Routines are experienced as pragmatic, obstructive and meaningful. The aim of the pragmatic routine was to ensure that daily working life works; this routine is practised more on the basis of rational arguments and obvious intentions. The obstructive routine had negative consequences for nursing practice and was described as nursing losing its humanity and violating the patient's integrity. The meaningful routine involved becoming one with the routine and for the nurses, it felt right and meaningful to adapt to it. Routines become meaningful when the individual action is in harmony with the cultural pattern on which the nursing work is based. Instead of letting contemporary practice passively become routine, routines can be assessed and developed using research and theoretical underpinnings as a starting point for nursing practice. Leaders have a special responsibility to develop and support meaningful routines. One approach could be to let wards examine their routines from a patient perspective on the basis of the themes of pragmatic, meaningful and obstructive routine. © 2010 Blackwell Publishing Ltd.

Narrative meaning making is associated with sudden gains in psychotherapy clients' mental health under routine clinical conditions.

PubMed

Adler, Jonathan M; Harmeling, Luke H; Walder-Biesanz, Ilana

2013-10-01

The present study had two aims: (a) to replicate previous findings regarding the characteristics of sudden gains (SGs) in psychotherapy under routine clinical conditions and (b) to examine whether clients' narrative meaning-making processes were associated with SGs in mental health. 54 psychotherapy clients completed the Systemic Therapy Inventory of Change (Pinsof et al., 2009) and wrote private narratives prior to beginning treatment and between every session for 12 assessment points over the course of psychotherapy for a variety of presenting problems. Clients' narratives were coded using existing systems (Adler, 2012; A. M. Hayes, Feldman, & Goldfried, 2006) to assess their content in eight themes: processing, avoidance, coherence, positive self, negative self, agency, hope, and hopelessness. The prevalence, magnitude, and timing of SGs in mental health observed in the present study were similar to those observed in prior research. Two narrative meaning-making processes-processing and coherence-were significantly associated with SGs in mental health. The present study significantly extends prior research on SGs, replicating the characteristics of these gains in routine clinical conditions with a measure of general functioning and identifying two narrative meaning-making processes that are associated with SGs in mental health.

Objections to routine clinical outcomes measurement in mental health services: any evidence so far?

PubMed

MacDonald, Alastair J D; Trauer, Tom

2010-12-01

Routine clinical outcomes measurement (RCOM) is gaining importance in mental health services. To examine whether criticisms published in advance of the development of RCOM have been borne out by data now available from such a programme. This was an observational study of routine ratings using HoNOS65+ at inception/admission and again at discharge in an old age psychiatry service from 1997 to 2008. Testable hypotheses were generated from each criticism amenable to empirical examination. Inter-rater reliability estimates were applied to observed differences between scores between community and ward patients using resampling. Five thousand one hundred eighty community inceptions and 862 admissions had HoNOS65+ ratings at referral/admission and discharge. We could find no evidence of gaming (artificially worse scores at inception and better at discharge), selection, attrition or detection bias, and ratings were consistent with diagnosis and level of service. Anticipated low levels of inter-rater reliability did not vitiate differences between levels of service. Although only hypotheses testable from within RCOM data were examined, and only 46% of eligible episodes had complete outcomes data, no evidence of the alleged biases were found. RCOM seems valid and practical in mental health services.

Reference Intervals of Hematology and Clinical Chemistry Analytes for 1-Year-Old Korean Children

PubMed Central

Lee, Hye Ryun; Roh, Eun Youn; Chang, Ju Young

2016-01-01

Background Reference intervals need to be established according to age. We established reference intervals of hematology and chemistry from community-based healthy 1-yr-old children and analyzed their iron status according to the feeding methods during the first six months after birth. Methods A total of 887 children who received a medical check-up between 2010 and 2014 at Boramae Hospital (Seoul, Korea) were enrolled. A total of 534 children (247 boys and 287 girls) were enrolled as reference individuals after the exclusion of data obtained from children with suspected iron deficiency. Hematology and clinical chemistry analytes were measured, and the reference value of each analyte was estimated by using parametric (mean±2 SD) or nonparametric methods (2.5-97.5th percentile). Iron, total iron-binding capacity, and ferritin were measured, and transferrin saturation was calculated. Results As there were no differences in the mean values between boys and girls, we established the reference intervals for 1-yr-old children regardless of sex. The analysis of serum iron status according to feeding methods during the first six months revealed higher iron, ferritin, and transferrin saturation levels in children exclusively or mainly fed formula than in children exclusively or mainly fed breast milk. Conclusions We established reference intervals of hematology and clinical chemistry analytes from community-based healthy children at one year of age. These reference intervals will be useful for interpreting results of medical check-ups at one year of age. PMID:27374715

Reference Intervals of Hematology and Clinical Chemistry Analytes for 1-Year-Old Korean Children.

PubMed

Lee, Hye Ryun; Shin, Sue; Yoon, Jong Hyun; Roh, Eun Youn; Chang, Ju Young

2016-09-01

Reference intervals need to be established according to age. We established reference intervals of hematology and chemistry from community-based healthy 1-yr-old children and analyzed their iron status according to the feeding methods during the first six months after birth. A total of 887 children who received a medical check-up between 2010 and 2014 at Boramae Hospital (Seoul, Korea) were enrolled. A total of 534 children (247 boys and 287 girls) were enrolled as reference individuals after the exclusion of data obtained from children with suspected iron deficiency. Hematology and clinical chemistry analytes were measured, and the reference value of each analyte was estimated by using parametric (mean±2 SD) or nonparametric methods (2.5-97.5th percentile). Iron, total iron-binding capacity, and ferritin were measured, and transferrin saturation was calculated. As there were no differences in the mean values between boys and girls, we established the reference intervals for 1-yr-old children regardless of sex. The analysis of serum iron status according to feeding methods during the first six months revealed higher iron, ferritin, and transferrin saturation levels in children exclusively or mainly fed formula than in children exclusively or mainly fed breast milk. We established reference intervals of hematology and clinical chemistry analytes from community-based healthy children at one year of age. These reference intervals will be useful for interpreting results of medical check-ups at one year of age.

A new generation of cancer genome diagnostics for routine clinical use: overcoming the roadblocks to personalized cancer medicine.

PubMed

Heuckmann, J M; Thomas, R K

2015-09-01

The identification of 'druggable' kinase gene alterations has revolutionized cancer treatment in the last decade by providing new and successfully targetable drug targets. Thus, genotyping tumors for matching the right patients with the right drugs have become a clinical routine. Today, advances in sequencing technology and computational genome analyses enable the discovery of a constantly growing number of genome alterations relevant for clinical decision making. As a consequence, several technological approaches have emerged in order to deal with these rapidly increasing demands for clinical cancer genome analyses. Here, we describe challenges on the path to the broad introduction of diagnostic cancer genome analyses and the technologies that can be applied to overcome them. We define three generations of molecular diagnostics that are in clinical use. The latest generation of these approaches involves deep and thus, highly sensitive sequencing of all therapeutically relevant types of genome alterations-mutations, copy number alterations and rearrangements/fusions-in a single assay. Such approaches therefore have substantial advantages (less time and less tissue required) over PCR-based methods that typically have to be combined with fluorescence in situ hybridization for detection of gene amplifications and fusions. Since these new technologies work reliably on routine diagnostic formalin-fixed, paraffin-embedded specimens, they can help expedite the broad introduction of personalized cancer therapy into the clinic by providing comprehensive, sensitive and accurate cancer genome diagnoses in 'real-time'. © The Author 2015. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.

Verification of an immunoturbidimetric assay for heart-type fatty acid-binding protein (H-FABP) on a clinical chemistry platform and establishment of the upper reference limit.

PubMed

Da Molin, Simona; Cappellini, Fabrizio; Falbo, Rosanna; Signorini, Stefano; Brambilla, Paolo

2014-11-01

Heart-type fatty acid-binding protein (H-FABP) is an early biomarker of cardiac injury. Randox Laboratories developed an immunoturbidimetric H-FABP assay for non-proprietary automated clinical chemistry analysers that could be useful in the emergency department. We verified the analytical performances claimed by Randox Laboratories on Roche Cobas 6000 clinical chemistry platform in use in our laboratory, and we defined our own 99th percentile upper reference limit for H-FABP. For the verification of method performances, we used pools of spared patient samples from routine and two levels of quality control material, while samples for the reference value study were collected from 545 blood donors. Following CLSI guidelines we verified limit of blank (LOB), limit of detection (LOD), limit of quantitation (LOQ), repeatability and within-laboratory precision, trueness, linearity, and the stability of H-FABP in EDTA over 24h. The LOQ (3.19 μg/L) was verified with a CV% of 10.4. The precision was verified for the low (mean 5.88 μg/L, CV=6.7%), the medium (mean 45.28 μg/L, CV=3.0%), and the high concentration (mean 88.81 μg/L, CV=4.0%). The trueness was verified as well as the linearity over the indicated measurement interval of 0.747-120 μg/L. The H-FABP in EDTA samples is stable throughout 24h both at room temperature and at 4 °C. The H-FABP 99th percentile upper reference limit for all subjects (3.60 μg/L, 95% CI 3.51-3.77) is more appropriate than gender-specific ones that are not statistically different. Copyright © 2014 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

On being green: can flow chemistry help?

PubMed

Ley, Steven V

2012-08-01

The principles of Green Chemistry are important but challenging drivers for most modern synthesis programs. To meet these challenges new flow chemistry tools are proving to be very effective by providing improved heat/mass transfer opportunities, lower solvent usage, less waste generation, hazardous compound containment, and the possibility of a 24/7 working regime. This machine-assisted approach can be used to effect repetitive or routine scale-up steps or when combined with reagent and scavenger cartridges, to achieve multi-step synthesis of complex natural products and pharmaceutical agents. Copyright © 2012 The Japan Chemical Journal Forum and Wiley Periodicals, Inc.

Assessment of three frequently used blood glucose monitoring devices in clinical routine.

PubMed

Zueger, Thomas; Schuler, Vanessa; Stettler, Christoph; Diem, Peter; Christ, Emanuel R

2012-07-12

Self-monitoring of blood glucose plays an important role in the management of diabetes and has been shown to improve metabolic control. The use of blood glucose meters in clinical practice requires sufficient reliability to allow adequate treatment. Direct comparison of different blood glucose meters in clinical practice, independent of the manufactures is scarce. We, therefore, aimed to evaluate three frequently used blood glucose meters in daily clinical practice. Capillary blood glucose was measured simultaneous using the following glucose meters: Contour® (Bayer Diabetes Care, Zürich, Switzerland), Accu-Chek® aviva (Roche Diagnostics, Rotkreuz, Switzerland), Free-Style® lite (Abbott Diabetes Care, Baar, Switzerland). The reference method consisted of the HemoCue® Glucose 201+ System (HemoCue® AB, Ängelholm, Sweden) with plasma conversion. The devices were assessed by comparison of the Mean Absolute Relative Differences (MARD), the Clarke Error Grid Analysis (EGA) and the compliance with the International Organization of Standardization criteria (ISO 15197:2003). Capillary blood samples were obtained from 150 patients. MARD was 10.1 ± 0.65%, 7.0 ± 0.62% and 7.8 ± 0.48% for Contour®, Accu-Chek® and Free-Style®, respectively. EGA showed 99.3% (Contour®), 98.7% (Accu-Chek®) and 100% (Free-Style®) of all measurements in zone A and B (clinically acceptable). The ISO criteria were fulfilled by Accu-Chek® (95.3%) and Free-Style® (96%), but not by Contour® (92%). In the present study the three glucose meters provided good agreement with the reference and reliable results in daily clinical routine. Overall, the Free-Style® and Accu-Chek® device slightly outperformed the Contour® device.

ASVCP quality assurance guidelines: control of preanalytical, analytical, and postanalytical factors for urinalysis, cytology, and clinical chemistry in veterinary laboratories.

PubMed

Gunn-Christie, Rebekah G; Flatland, Bente; Friedrichs, Kristen R; Szladovits, Balazs; Harr, Kendal E; Ruotsalo, Kristiina; Knoll, Joyce S; Wamsley, Heather L; Freeman, Kathy P

2012-03-01

In December 2009, the American Society for Veterinary Clinical Pathology (ASVCP) Quality Assurance and Laboratory Standards committee published the updated and peer-reviewed ASVCP Quality Assurance Guidelines on the Society's website. These guidelines are intended for use by veterinary diagnostic laboratories and veterinary research laboratories that are not covered by the US Food and Drug Administration Good Laboratory Practice standards (Code of Federal Regulations Title 21, Chapter 58). The guidelines have been divided into 3 reports: (1) general analytical factors for veterinary laboratory performance and comparisons; (2) hematology, hemostasis, and crossmatching; and (3) clinical chemistry, cytology, and urinalysis. This particular report is one of 3 reports and documents recommendations for control of preanalytical, analytical, and postanalytical factors related to urinalysis, cytology, and clinical chemistry in veterinary laboratories and is adapted from sections 1.1 and 2.2 (clinical chemistry), 1.3 and 2.5 (urinalysis), 1.4 and 2.6 (cytology), and 3 (postanalytical factors important in veterinary clinical pathology) of these guidelines. These guidelines are not intended to be all-inclusive; rather, they provide minimal guidelines for quality assurance and quality control for veterinary laboratory testing and a basis for laboratories to assess their current practices, determine areas for improvement, and guide continuing professional development and education efforts. © 2012 American Society for Veterinary Clinical Pathology.

[How to Interpret and Use Routine Laboratory Data--Our Methods to Interpret Routine Laboratory Data--Chairmen's Introductory Remarks].

PubMed

Honda, Takayuki; Tozuka, Minoru

2015-09-01

In the reversed clinicopathological conference (R-CPC), three specialists in laboratory medicine interpreted routine laboratory data independently in order to understand the detailed state of a patient. R-CPC is an educational method to use laboratory data appropriately, and it is also important to select differential diagnoses in a process of clinical reasoning in addition to the present illness and physical examination. Routine laboratory tests can be performed repeatedly at a relatively low cost, and their time-series analysis can be performed. Interpretation of routine laboratory data is almost the same as taking physical findings. General findings are initially checked and then the state of each organ is examined. Although routine laboratory tests cost little, we can gain much more information from them about the patient than physical examinations.

Investigation of Factors Affecting Body Temperature Changes During Routine Clinical Head Magnetic Resonance Imaging

PubMed Central

Kim, Myeong Seong

2016-01-01

Background Pulsed radiofrequency (RF) magnetic fields, required to produce magnetic resonance imaging (MRI) signals from tissue during the MRI procedure have been shown to heat tissues. Objectives To investigate the relationship between body temperature rise and the RF power deposited during routine clinical MRI procedures, and to determine the correlation between this effect and the body’s physiological response. Patients and Methods We investigated 69 patients from the Korean national cancer center to identify the main factors that contribute to an increase in body temperature (external factors and the body’s response) during a clinical brain MRI. A routine protocol sequence of MRI scans (1.5 T and 3.0 T) was performed. The patient’s tympanic temperature was recorded before and immediately after the MRI procedure and compared with changes in variables related to the body’s physiological response to heat. Results Our investigation of the physiological response to RF heating indicated a link between increasing age and body temperature. A higher increase in body temperature was observed in older patients after a 3.0-T MRI (r = 0.07, P = 0.29 for 1.5-T MRI; r = 0.45, P = 0.002 for 3.0-T MRI). The relationship between age and body heat was related to the heart rate (HR) and changes in HR during the MRI procedure; a higher RF power combined with a reduction in HR resulted in an increase in body temperature. Conclusion A higher magnetic field strength and a decrease in the HR resulted in an increase in body temperature during the MRI procedure. PMID:27895872

Environmental chemistry and ecotoxicology: in greater demand than ever.

PubMed

Scheringer, Martin

2017-01-01

Environmental chemistry and ecotoxicology have been losing support, resources, and recognition at universities for many years. What are the possible causes of this process? A first problem may be that the need for research and teaching in environmental chemistry and ecotoxicology is no longer seen because chemical pollution problems are considered as largely solved. Second, environmental chemistry and ecotoxicology may be seen as fields dominated by routine work and where there are not many interesting research questions left. A third part of the problem may be that other environmental impacts such as climate change are given higher priority than chemical pollution problems. Here, several cases are presented that illustrate the great demand for innovative research and teaching in environmental chemistry and ecotoxicology. It is crucial that environmental chemistry and ecotoxicology are rooted in academic science and are provided with sufficient equipment, resources, and prospects for development.

Assessing barriers to adherence in routine clinical care for pediatric kidney transplant patients.

PubMed

Varnell, Charles D; Rich, Kristin L; Nichols, Melissa; Dahale, Devesh; Goebel, Jens W; Pai, Ahna L H; Hooper, David K; Modi, Avani C

2017-11-01

Patient-identified barriers to immunosuppressive medications are associated with poor adherence and negative clinical outcomes in transplant patients. Assessment of adherence barriers is not part of routine post-transplant care, and studies regarding implementing such a process in a reliable way are lacking. Using the Model for Improvement and PDSA cycles, we implemented a system to identify adherence barriers, including patient-centered design of a barriers assessment tool, identification of eligible patients, clear roles for clinic staff, and creating a culture of non-judgmental discussion around adherence. We performed time-series analysis of our process measure. Secondary analyses examined the endorsement and concordance of adherence barriers between patient-caregiver dyads. After three methods of testing, the most reliable delivery system was an EHR-integrated tablet that alerted staff of patient eligibility for assessment. Barriers were endorsed by 35% of caregivers (n=85) and 43% of patients (n=60). The most frequently patient-endorsed barriers were forgetting, poor taste, and side effects. Caregivers endorsed forgetting and side effects. Concordance between patient-caregiver dyads was fair (k=0.299). Standardized adherence barriers assessment is feasible in the clinical care of pediatric kidney transplant patients. Features necessary for success included automation, redundant systems with designated staff to identify and mitigate failures, aligned reporting structures, and reliable measurement approaches. Future studies will examine whether barriers predict clinical outcomes (eg, organ rejection, graft loss). © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Clinical indicators for routine use in the evaluation of early psychosis intervention: development, training support and inter-rater reliability.

PubMed

Catts, Stanley V; Frost, Aaron D J; O'Toole, Brian I; Carr, Vaughan J; Lewin, Terry; Neil, Amanda L; Harris, Meredith G; Evans, Russell W; Crissman, Belinda R; Eadie, Kathy

2011-01-01

Clinical practice improvement carried out in a quality assurance framework relies on routinely collected data using clinical indicators. Herein we describe the development, minimum training requirements, and inter-rater agreement of indicators that were used in an Australian multi-site evaluation of the effectiveness of early psychosis (EP) teams. Surveys of clinician opinion and face-to-face consensus-building meetings were used to select and conceptually define indicators. Operationalization of definitions was achieved by iterative refinement until clinicians could be quickly trained to code indicators reliably. Calculation of percentage agreement with expert consensus coding was based on ratings of paper-based clinical vignettes embedded in a 2-h clinician training package. Consensually agreed upon conceptual definitions for seven clinical indicators judged most relevant to evaluating EP teams were operationalized for ease-of-training. Brief training enabled typical clinicians to code indicators with acceptable percentage agreement (60% to 86%). For indicators of suicide risk, psychosocial function, and family functioning this level of agreement was only possible with less precise 'broad range' expert consensus scores. Estimated kappa values indicated fair to good inter-rater reliability (kappa > 0.65). Inspection of contingency tables (coding category by health service) and modal scores across services suggested consistent, unbiased coding across services. Clinicians are able to agree upon what information is essential to routinely evaluate clinical practice. Simple indicators of this information can be designed and coding rules can be reliably applied to written vignettes after brief training. The real world feasibility of the indicators remains to be tested in field trials.

Impact of a Routine, Opt-Out HIV Testing Program on HIV Testing and Case Detection in North Carolina Sexually-Transmitted Disease Clinics

PubMed Central

Klein, Pamela W.; Messer, Lynne C.; Myers, Evan R.; Weber, David J.; Leone, Peter A.; Miller, William C.

2016-01-01

The impact of routine, opt-out HIV testing programs in clinical settings is inconclusive. The objective of this study was to estimate the impact of an expanded, routine HIV testing program in North Carolina sexually transmitted disease (STD) clinics on HIV testing and case detection. Adults aged 18–64 who received an HIV test in a North Carolina STD clinic July 1, 2005 through June 30, 2011 were included in this analysis, dichotomized at the date of implementation on November 1, 2007. HIV testing and case detection counts and rates were analyzed using interrupted time series analysis, and Poisson and multilevel logistic regression. Pre-intervention, 426 new HIV-infected cases were identified from 128,029 tests (0.33%), whereas 816 new HIV-infected cases were found from 274,745 tests post-intervention (0.30%). Pre-intervention, HIV testing increased by 55 tests per month (95% confidence interval [CI]: 41, 72), but only 34 tests per month (95% CI: 26, 42) post-intervention. Increases in HIV testing rates were most pronounced in females and non-Hispanic whites. A slight pre-intervention decline in case detection was mitigated by the intervention (mean difference [MD]=0.01; 95% CI: −0.02, 0.05). Increases in case detection rates were observed among females and non-Hispanic blacks. The impact of a routine HIV screening in North Carolina STD clinics was marginal, with the greatest benefit among persons not traditionally targeted for HIV testing. The use of a pre-intervention comparison period identified important temporal trends that otherwise would have been ignored. PMID:24825338

Audit of the autoantibody test, EarlyCDT®-lung, in 1600 patients: an evaluation of its performance in routine clinical practice.

PubMed

Jett, James R; Peek, Laura J; Fredericks, Lynn; Jewell, William; Pingleton, William W; Robertson, John F R

2014-01-01

EarlyCDT(®)-Lung may enhance detection of early stage lung cancer by aiding physicians in assessing high-risk patients through measurement of biological markers (i.e., autoantibodies). The test's performance characteristics in routine clinical practice were evaluated by auditing clinical outcomes of 1613 US patients deemed at high risk for lung cancer by their physician, who ordered the EarlyCDT-Lung test for their patient. Clinical outcomes for all 1613 patients who provided HIPAA authorization are reported. Clinical data were collected from each patient's treating physician. Pathology reports when available were reviewed for diagnostic classification. Staging was assessed on histology, otherwise on imaging. Six month follow-up for the positives/negatives was 99%/93%. Sixty-one patients (4%) were identified with lung cancer, 25 of whom tested positive by EarlyCDT-Lung (sensitivity=41%). A positive EarlyCDT-Lung test on the current panel was associated with a 5.4-fold increase in lung cancer incidence versus a negative. Importantly, 57% (8/14) of non-small cell lung cancers detected as positive (where stage was known) were stage I or II. EarlyCDT-Lung has been extensively tested and validated in case-control settings and has now been shown in this audit to perform in routine clinical practice as predicted. EarlyCDT-Lung may be a complementary tool to CT for detection of early lung cancer. Copyright © 2013 The Authors. Published by Elsevier Ireland Ltd.. All rights reserved.

A guide to defining the competence required of a consultant in clinical chemistry and laboratory medicine.

PubMed

Beastall, Graham; Kenny, Desmond; Laitinen, Paivi; ten Kate, Joop

2005-01-01

A definition has been agreed for the most senior professional (consultant) in clinical chemistry and laboratory medicine. A model job description for a consultant has been determined, which is intended to act as a toolkit to assist employing authorities and professional bodies to define the role of individual consultant posts. A total of 86 competences for a consultant have been designated and expressed in the form of simple generic proficiency standards. These competences have been allocated to six broad areas: clinical [13]; scientific [15]; technical [12]; communication [12]; management and leadership [20]; professional autonomy and accountability [14]. The competences are intended to be illustrative rather than definitive and to enable the duties of any consultant post to be defined. Assessment of competence is likely to entail consideration of qualifications, registration status, continuing professional development and performance review. The project is intended as a guide to European societies of clinical chemistry and laboratory medicine. The guide should be capable of local interpretation to encourage a greater degree of commonality in the role of the consultant whilst protecting national identity. The guide should stimulate international understanding and collaboration and contribute to an overall improvement in the quality of practice.

Endogenous glucocorticoid analysis by liquid chromatography-tandem mass spectrometry in routine clinical laboratories.

PubMed

Hawley, James M; Keevil, Brian G

2016-09-01

Liquid chromatography-tandem mass spectrometry (LC-MS/MS) is a powerful analytical technique that offers exceptional selectivity and sensitivity. Used optimally, LC-MS/MS provides accurate and precise results for a wide range of analytes at concentrations that are difficult to quantitate with other methodologies. Its implementation into routine clinical biochemistry laboratories has revolutionised our ability to analyse small molecules such as glucocorticoids. Whereas immunoassays can suffer from matrix effects and cross-reactivity due to interactions with structural analogues, the selectivity offered by LC-MS/MS has largely overcome these limitations. As many clinical guidelines are now beginning to acknowledge the importance of the methodology used to provide results, the advantages associated with LC-MS/MS are gaining wider recognition. With their integral role in both the diagnosis and management of hypo- and hyperadrenal disorders, coupled with their widespread pharmacological use, the accurate measurement of glucocorticoids is fundamental to effective patient care. Here, we provide an up-to-date review of the LC-MS/MS techniques used to successfully measure endogenous glucocorticoids, particular reference is made to serum, urine and salivary cortisol. Copyright © 2016 Elsevier Ltd. All rights reserved.

Sequencing-based breast cancer diagnostics as an alternative to routine biomarkers.

PubMed

Rantalainen, Mattias; Klevebring, Daniel; Lindberg, Johan; Ivansson, Emma; Rosin, Gustaf; Kis, Lorand; Celebioglu, Fuat; Fredriksson, Irma; Czene, Kamila; Frisell, Jan; Hartman, Johan; Bergh, Jonas; Grönberg, Henrik

2016-11-30

Sequencing-based breast cancer diagnostics have the potential to replace routine biomarkers and provide molecular characterization that enable personalized precision medicine. Here we investigate the concordance between sequencing-based and routine diagnostic biomarkers and to what extent tumor sequencing contributes clinically actionable information. We applied DNA- and RNA-sequencing to characterize tumors from 307 breast cancer patients with replication in up to 739 patients. We developed models to predict status of routine biomarkers (ER, HER2,Ki-67, histological grade) from sequencing data. Non-routine biomarkers, including mutations in BRCA1, BRCA2 and ERBB2(HER2), and additional clinically actionable somatic alterations were also investigated. Concordance with routine diagnostic biomarkers was high for ER status (AUC = 0.95;AUC(replication) = 0.97) and HER2 status (AUC = 0.97;AUC(replication) = 0.92). The transcriptomic grade model enabled classification of histological grade 1 and histological grade 3 tumors with high accuracy (AUC = 0.98;AUC(replication) = 0.94). Clinically actionable mutations in BRCA1, BRCA2 and ERBB2(HER2) were detected in 5.5% of patients, while 53% had genomic alterations matching ongoing or concluded breast cancer studies. Sequencing-based molecular profiling can be applied as an alternative to histopathology to determine ER and HER2 status, in addition to providing improved tumor grading and clinically actionable mutations and molecular subtypes. Our results suggest that sequencing-based breast cancer diagnostics in a near future can replace routine biomarkers.

The relationship of interictal epileptiform discharges to clinical epilepsy severity: A study of routine EEGs and review of the literature

PubMed Central

Selvitelli, Megan F.; Walker, Linsey M.; Schomer, Donald L.; Chang, Bernard S.

2010-01-01

Purpose EEGs are widely used to detect interictal epileptiform discharges (IEDs) in patients with a known history of seizures. However, prior studies have not found a consistent association between the presence or frequency of IEDs and clinical epilepsy severity, possibly because of differences in subject characteristics and recording techniques. We sought to investigate this relationship in a population and setting reflective of the most common clinical usage. Methods We analyzed EEGs and clinical records of all consenting patients with a history of at least two presumed focal-onset seizures who presented for routine EEG recording over one year’s time in an academic neurophysiology laboratory (n = 129). Results Despite adequate statistical power, we did not find an association between the presence or absence of IEDs or IED frequency and the most recently determined seizure frequency (median 4 per year). A higher IED incidence was seen in subjects with longer epilepsy duration (p = 0.04). Neither IED incidence nor frequency (median 10.0 per hour) correlated with age or antiepileptic drug use. Conclusions Our results differ from those of some prior studies, most of which focused on more narrow subject populations, suggesting that the patient’s clinical circumstances must be taken into account before assuming the utility of IEDs on routine EEG in predicting epilepsy severity. PMID:20234317

Usefulness of component resolved analysis of cat allergy in routine clinical practice.

PubMed

Eder, Katharina; Becker, Sven; San Nicoló, Marion; Berghaus, Alexander; Gröger, Moritz

2016-01-01

Cat allergy is of great importance, and its prevalence is increasing worldwide. Cat allergens and house dust mite allergens represent the major indoor allergens; however, they are ubiquitous. Cat sensitization and allergy are known risk factors for rhinitis, bronchial hyperreactivity and asthma. Thus, the diagnosis of sensitization to cats is important for any allergist. 70 patients with positive skin prick tests for cats were retrospectively compared regarding their skin prick test results, as well as their specific immunoglobulin E antibody profiles with regard to their responses to the native cat extract, rFel d 1, nFel d 2 and rFel d 4. 35 patients were allergic to cats, as determined by positive anamnesis and/or nasal provocation with cat allergens, and 35 patients exhibited clinically non-relevant sensitization, as indicated by negative anamnesis and/or a negative nasal allergen challenge. Native cat extract serology testing detected 100% of patients who were allergic to cats but missed eight patients who showed sensitization in the skin prick test and did not have allergic symptoms. The median values of the skin prick test, as well as those of the specific immunoglobulin E antibodies against the native cat extract, were significantly higher for allergic patients than for patients with clinically non-relevant sensitization. Component based diagnostic testing to rFel d 1 was not as reliable. Sensitization to nFel d 2 and rFel d 4 was seen only in individual patients. Extract based diagnostic methods for identifying cat allergy and sensitization, such as the skin prick test and native cat extract serology, remain crucial in routine clinical practice. In our study, component based diagnostic testing could not replace these methods with regard to the detection of sensitization to cats and differentiation between allergy and sensitization without clinical relevance. However, component resolved allergy diagnostic tools have individual implications, and future

Post-standardization of routine creatinine assays: are they suitable for clinical applications.

PubMed

Jassam, Nuthar; Weykamp, Cas; Thomas, Annette; Secchiero, Sandra; Sciacovelli, Laura; Plebani, Mario; Thelen, Marc; Cobbaert, Christa; Perich, Carmen; Ricós, Carmen; Paula, Faria A; Barth, Julian H

2017-05-01

Introduction Reliable serum creatinine measurements are of vital importance for the correct classification of chronic kidney disease and early identification of kidney injury. The National Kidney Disease Education Programme working group and other groups have defined clinically acceptable analytical limits for creatinine methods. The aim of this study was to re-evaluate the performance of routine creatinine methods in the light of these defined limits so as to assess their suitability for clinical practice. Method In collaboration with the Dutch External Quality Assurance scheme, six frozen commutable samples, with a creatinine concentration ranging from 80 to 239  μmol/L and traceable to isotope dilution mass spectrometry, were circulated to 91 laboratories in four European countries for creatinine measurement and estimated glomerular filtration rate calculation. Two out of the six samples were spiked with glucose to give high and low final concentrations of glucose. Results Results from 89 laboratories were analysed for bias, imprecision (%CV) for each creatinine assay and total error for estimated glomerular filtration rate. The participating laboratories used analytical instruments from four manufacturers; Abbott, Beckman, Roche and Siemens. All enzymatic methods in this study complied with the National Kidney Disease Education Programme working group recommended limits of bias of 5% above a creatinine concentration of 100  μmol/L. They also did not show any evidence of interference from glucose. In addition, they also showed compliance with the clinically recommended %CV of ≤4% across the analytical range. In contrast, the Jaffe methods showed variable performance with regard to the interference of glucose and unsatisfactory bias and precision. Conclusion Jaffe-based creatinine methods still exhibit considerable analytical variability in terms of bias, imprecision and lack of specificity, and this variability brings into question their clinical utility

Baseline hematology and clinical chemistry results from captive-raised trumpeter swans

USGS Publications Warehouse

Olsen, Glenn H.; Rininger, D.L.; Ets, M.K.; Sladen, William J. L.; Rees, Eileen C.; Earnst, Susan L.; Coulson, John C.

2002-01-01

Results from hematology and clinical chemistry tests are presented for healthy captive-raised Trumpeter Swans (Cygnus buccinator) to help establish baseline data. Blood samples were obtained from 14 cygnets between the ages of three to four and seven to eight months that were the subjects of a study to teach migration routes to swans. Males and females differed significantly in asparatate aminotransferase, alanine aminotransferase and total protein. Age categories differed significantly in hematocrit, white blood cell counts, alkaline phosphatase, aspar-rate aminotransferase, glucose, cholesterol and uric acid. There were no significant differences among age categories in values of alanine aminotransferase, calcium, triglycerides and total protein.

Benchmarking routine psychological services: a discussion of challenges and methods.

PubMed

Delgadillo, Jaime; McMillan, Dean; Leach, Chris; Lucock, Mike; Gilbody, Simon; Wood, Nick

2014-01-01

Policy developments in recent years have led to important changes in the level of access to evidence-based psychological treatments. Several methods have been used to investigate the effectiveness of these treatments in routine care, with different approaches to outcome definition and data analysis. To present a review of challenges and methods for the evaluation of evidence-based treatments delivered in routine mental healthcare. This is followed by a case example of a benchmarking method applied in primary care. High, average and poor performance benchmarks were calculated through a meta-analysis of published data from services working under the Improving Access to Psychological Therapies (IAPT) Programme in England. Pre-post treatment effect sizes (ES) and confidence intervals were estimated to illustrate a benchmarking method enabling services to evaluate routine clinical outcomes. High, average and poor performance ES for routine IAPT services were estimated to be 0.91, 0.73 and 0.46 for depression (using PHQ-9) and 1.02, 0.78 and 0.52 for anxiety (using GAD-7). Data from one specific IAPT service exemplify how to evaluate and contextualize routine clinical performance against these benchmarks. The main contribution of this report is to summarize key recommendations for the selection of an adequate set of psychometric measures, the operational definition of outcomes, and the statistical evaluation of clinical performance. A benchmarking method is also presented, which may enable a robust evaluation of clinical performance against national benchmarks. Some limitations concerned significant heterogeneity among data sources, and wide variations in ES and data completeness.

Effectiveness of Sucrose Used Routinely for Pain Relief and Neonatal Clinical Risk in Preterm Infants: A Nonrandomized Study.

PubMed

Valeri, Beatriz Oliveira; Gaspardo, Cláudia Maria; Martinez, Francisco Eulógio; Linhares, Maria Beatriz Martins

2018-01-03

Preterm infants (PI) requiring the Neonatal Intensive Care Unit (NICU) are exposed to early repetitive pain/distress. Little is known about how pain relief strategies interact with infants'clinical health status, such as severity of illness with pain responses. This study aimed to examine main and interactive effects of routine sucrose intervention and neonatal clinical risk (NCR) on biobehavioral pain reactivity-recovery in PI during painful blood collection procedures. Very-low birthweight PI (n=104) were assigned to Low and High Clinical Risk Groups, according to the Clinical Risk Index for Babies. Sucrose-Group (SG; n=52) received sucrose solution (25%; 0.5▒mL/Kg) two minutes before the procedures and Control-Group (CG) received standard-care. Biobehavioral pain reactivity-recovery was assessed according to the Neonatal Facial Coding System, Sleep-wake state scale, crying time, and heart rate (HR) at five phases (Baseline, Antisepsis, Puncture, Recovery-Dressing and Recovery-Resting). Repeated measure ANOVA with mixed-design was performed considering pain assessment phases, intervention group, and NCR. Independent of NCR, sucrose presented main effect in decreasing neonates' facial activity pain responses and crying time, during Puncture and Recovery-Resting. Independent of NCR level or routine sucrose intervention, all neonates displayed activated state in Puncture and decreased biobehavioral responses in Recovery-Resting phase. Although no sucrose or NCR effects were observed on physiological reactivity, all neonates exhibited physiological recovery 10 minutes after puncture, reaching the same HR patterns as the Baseline. Independent of NCR level, sucrose intervention for pain relief during acute painful procedures was effective to reduce pain intensity and increase biobehavioral regulation.

Adoption of routine telemedicine in Norway: the current picture

PubMed Central

Zanaboni, Paolo; Knarvik, Undine; Wootton, Richard

2014-01-01

Background Telemedicine appears to be ready for wider adoption. Although existing research evidence is useful, the adoption of routine telemedicine in healthcare systems has been slow. Objective We conducted a study to explore the current use of routine telemedicine in Norway, at national, regional, and local levels, to provide objective and up-to-date information and to estimate the potential for wider adoption of telemedicine. Design A top-down approach was used to collect official data on the national use of telemedicine from the Norwegian Patient Register. A bottom-up approach was used to collect complementary information on the routine use of telemedicine through a survey conducted at the five largest publicly funded hospitals. Results Results show that routine telemedicine has been adopted in all health regions in Norway and in 68% of hospitals. Despite being widely adopted, the current level of use of telemedicine is low compared to the number of face-to-face visits. Examples of routine telemedicine can be found in several clinical specialties. Most services connect different hospitals in secondary care, and they are mostly delivered as teleconsultations via videoconference. Conclusions Routine telemedicine in Norway has been widely adopted, probably for geographical reasons, as in other settings. However, the level of use of telemedicine in Norway is rather low, and it has significant potential for further development as an alternative to face-to-face outpatient visits. This study is a first attempt to map routine telemedicine at regional, institutional, and clinical levels, and it provides useful information to understand the adoption of telemedicine in routine healthcare and to measure change in future updates. PMID:24433942

Feasibility of real-time capture of routine clinical data in the electronic health record: a hospital-based, observational service-evaluation study

PubMed Central

Archbold, R Andrew; Weerackody, Roshan; Barnes, Michael R; Lee, Aaron M; Janjuha, Surjeet; Gutteridge, Charles; Robson, John; Timmis, Adam

2018-01-01

Objectives The electronic health record (EHR) is underused in the hospital setting. The aim of this service evaluation study was to respond to National Health Service (NHS) Digital’s ambition for a paperless NHS by capturing routinely collected cardiac outpatient data in the EHR to populate summary patient reports and provide a resource for audit and research. Design A PowerForm template was developed within the Cerner EHR, for real-time entry of routine clinical data by clinicians attending a cardiac outpatient clinic. Data captured within the PowerForm automatically populated a SmartTemplate to generate a view-only report that was immediately available for the patient and for electronic transmission to the referring general practitioner (GP). Results During the first 8 months, the PowerForm template was used in 61% (360/594) of consecutive outpatient referrals increasing from 42% to 77% during the course of the study. Structured patient reports were available for immediate sharing with the referring GP using Cerner Health Information Exchange technology while electronic transmission was successfully developed in a substudy of 64 cases, with direct delivery by the NHS Data Transfer Service in 29 cases and NHS mail in the remainder. In feedback, the report’s immediate availability was considered very or extremely important by >80% of the patients and GPs who were surveyed. Both groups reported preference of the patient report to the conventional typed letter. Deidentified template data for all 360 patients were successfully captured within the Trust system, confirming availability of these routinely collected outpatient data for audit and research. Conclusion Electronic template development tailored to the requirements of a specialist outpatient clinic facilitates capture of routinely collected data within the Cerner EHR. These data can be made available for audit and research. They can also be used to enhance communication by populating structured reports

Time lapse imaging: is it time to incorporate this technology into routine clinical practice?

PubMed

Bhide, Priya; Maheshwari, Abha; Cutting, Rachel; Seenan, Susan; Patel, Anita; Khan, Khalid; Homburg, Roy

2017-06-01

Time-lapse imaging (TLI) systems for embryo incubation, assessment and selection are a novel technology available to in vitro fertilization (IVF) clinics. However, there is uncertainty about their clinical and cost-effectiveness and insufficient good quality evidence to warrant their routine use. Despite this, enthusiastic commercial marketing and slipping clinical equipoise have led to the widespread hasty introduction of this technology into practice, often at a considerable expense to the patient. We have reviewed the published literature and aim to summarize the strengths, weaknesses, opportunities and threats of these systems. These specialized incubators provide undisturbed embryo culture conditions and, by almost continuous monitoring of embryo development, generate morphokinetic parameters to aid embryo selection. They are thus hypothesized to improve outcomes following IVF. Although literature reports improved reproductive outcomes, these outcomes are largely surrogate and there is a paucity of studies reporting live births. The use of time lapse systems may reduce early pregnancy loss, increase elective single embryo transfers and limit multiple pregnancies through better embryo selection. However, the quality of the studies and hence the evidence so far, is low to moderate quality. We recommend further research producing robust high-quality evidence for and against the use of these systems.

Safety of ranibizumab in routine clinical practice: 1-year retrospective pooled analysis of four European neovascular AMD registries within the LUMINOUS programme.

PubMed

Holz, Frank G; Bandello, Francesco; Gillies, Mark; Mitchell, Paul; Osborne, Aaron; Sheidow, Tom; Souied, Eric; Figueroa, Marta S

2013-09-01

Evaluation of 1-year safety profile of intravitreal ranibizumab 0.5 mg in neovascular age-related macular degeneration (NV-AMD) within routine clinical practice. The LUMINOUS programme comprises a prospective observational study assessing ranibizumab 'real-world' safety and clinical effectiveness across licensed indications worldwide and an annual retrospective pooled safety analysis from completed NV-AMD ranibizumab registries. 1-year data from four European registries are available. This retrospective pooled safety analysis assessed 1-year incidence rates for safety events of particular interest (key ocular or systemic events possibly related to the injection procedure or vascular endothelial growth factor inhibition) together with treatment exposure. Patients were treated according to local protocols within the ranibizumab licence. Data of 4444 patients from registries in Germany (n=3470), the Netherlands (n=243), Belgium (n=260) and Sweden (n=471) were retrospectively pooled. Between 70.4% and 84.4% of enrolled patients completed 1 year of follow-up. Most frequent overall ocular events of particular interest were retinal pigment epithelial tears (27 patients; <1%) and intraocular pressure-related events (12 patients; <0.3%). Most frequent non-ocular event of particular interest was stroke (19 patients; 0.4%); annual incidence of stroke was low across all registries (0.0-0.5%). Ranibizumab demonstrated favourable 1-year safety profile for NV-AMD in this routine clinical practice sample, consistent with previous reported trial data. Additional data from a larger patient population are needed to better describe the long-term safety profile of ranibizumab in routine clinical practice and further evaluate risk for infrequent but serious events in 'real-life' settings. The 5-year LUMINOUS prospective observational study will address this need.

Laboratory Exercises to Teach Clinically Relevant Chemistry of Antibiotics

PubMed Central

Chelette, Candace T.

2014-01-01

Objectives. To design, implement, and evaluate student performance on clinically relevant chemical and spectral laboratory exercises on antibiotics. Design. In the first of 2 exercises, second-year pharmacy students enrolled in an integrated laboratory sequence course studied the aqueous stability of ß-lactam antibiotics using a spectral visual approach. In a second exercise, students studied the tendency of tetracycline, rifamycins, and fluoroquinolones to form insoluble chelate complexes (turbidity) with polyvalent metals. Assessment. On a survey to assess achievement of class learning objectives, students agreed the laboratory activities helped them better retain important information concerning antibiotic stability and interactions. A significant improvement was observed in performance on examination questions related to the laboratory topics for 2012 and 2013 students compared to 2011 students who did not complete the laboratory. A 1-year follow-up examination question administered in a separate course showed >75% of the students were able to identify rifamycins-food interactions compared with <25% of students who had not completed the laboratory exercises. Conclusion. The use of spectral visual approaches allowed students to investigate antibiotic stability and interactions, thus reinforcing the clinical relevance of medicinal chemistry. Students’ performance on questions at the 1-year follow-up suggested increased retention of the concepts learned as a result of completing the exercises. PMID:24672070

Laboratory exercises to teach clinically relevant chemistry of antibiotics.

PubMed

El Sayed, Khalid A; Chelette, Candace T

2014-03-12

To design, implement, and evaluate student performance on clinically relevant chemical and spectral laboratory exercises on antibiotics. In the first of 2 exercises, second-year pharmacy students enrolled in an integrated laboratory sequence course studied the aqueous stability of ß-lactam antibiotics using a spectral visual approach. In a second exercise, students studied the tendency of tetracycline, rifamycins, and fluoroquinolones to form insoluble chelate complexes (turbidity) with polyvalent metals. On a survey to assess achievement of class learning objectives, students agreed the laboratory activities helped them better retain important information concerning antibiotic stability and interactions. A significant improvement was observed in performance on examination questions related to the laboratory topics for 2012 and 2013 students compared to 2011 students who did not complete the laboratory. A 1-year follow-up examination question administered in a separate course showed >75% of the students were able to identify rifamycins-food interactions compared with <25% of students who had not completed the laboratory exercises. The use of spectral visual approaches allowed students to investigate antibiotic stability and interactions, thus reinforcing the clinical relevance of medicinal chemistry. Students' performance on questions at the 1-year follow-up suggested increased retention of the concepts learned as a result of completing the exercises.

Cognitive-behavioural therapy for outpatients with eating disorders: effectiveness for a transdiagnostic group in a routine clinical setting.

PubMed

Turner, Hannah; Marshall, Emily; Stopa, Lusia; Waller, Glenn

2015-05-01

Whilst there is a growing evidence to support the impact of cognitive-behavioural therapy (CBT) in the treatment of adults with eating disorders, much of this evidence comes from tightly controlled efficacy trials. This study aimed to add to the evidence regarding the effectiveness of CBT when delivered in a routine clinical setting. The participants were 203 adults presenting with a range of eating disorder diagnoses, who were offered CBT in an out-patient community eating disorders service in the UK. Patients completed measures of eating disorder pathology at the start of treatment, following the sixth session, and at the end of treatment. Symptoms of anxiety, depression, and psychosocial functioning were measured pre- and post-treatment. Approximately 55% of patients completed treatment, and there were no factors that predicted attrition. There were significant improvements in eating disorder psychopathology, anxiety, depression and general functioning, with particular changes in eating attitudes in the early part of therapy. Effect sizes were medium to large for both completer and intention to treat analyses. These findings confirm that evidence-based forms of CBT can be delivered with strong outcomes in routine clinical settings. Clinicians should be encouraged to deliver evidence-based treatments when working in these settings. Copyright © 2015 Elsevier Ltd. All rights reserved.

Diagnostic yield of a routine magnetic resonance imaging in tinnitus and clinical relevance of the anterior inferior cerebellar artery loops.

PubMed

Hoekstra, Carlijn E L; Prijs, Vera F; van Zanten, Gijsbert A

2015-02-01

To assess the diagnostic yield of a routine magnetic resonance imaging (MRI) scan in patients with (unilateral) chronic tinnitus, to define the frequency of incidental findings, and to assess the clinical relevance of potentially found anterior inferior cerebellar artery (AICA) loops. Retrospective cohort study. Tertiary Tinnitus Care Group at the University Medical Center Utrecht. Three hundred twenty-one patients with chronic tinnitus. Routine diagnostic magnetic resonance imaging (MRI) and diagnostic auditory brainstem responses (ABR) when an AICA loop was found. Relationship between abnormalities on MRI and tinnitus. In 138 patients (45%), an abnormality on the MRI scan was described. In only 7 patients (2.2%), the abnormality probably related to the patient's tinnitus. Results were not significantly better in patients with unilateral tinnitus (abnormalities in 3.2%). Incidental findings, not related to the tinnitus, were found in 41% of the patients. In 70 patients (23%), an AICA loop was found in the internal auditory canal. No significant relationships were found between the presence of an AICA loop and the side of the tinnitus, abnormalities on the ABR or complaints specific to nerve compression syndrome. A routine MRI is of little or no value in patients with tinnitus with persistent complaints. Anterior inferior cerebellar artery loops are often encountered on an MRI scan but rarely relate to the tinnitus and should thus be considered incidental findings. It is advised to only perform an MRI when on clinical grounds a specific etiology with tinnitus as the symptom seems probable.

Identifying pain-related concerns in routine follow-up clinics following oral and oropharyngeal cancer.

PubMed

Rogers, Simon N; Cleator, Alexander J; Lowe, Derek; Ghazali, Naseem

2012-08-10

To describe clinical characteristics of head and neck cancer (HNC) patients with pain and those wishing to discuss pain concerns during consultation. Cross-sectional, questionnaire study using University of Washington Quality of Life, version 4 (UW-QOL) and the Patients Concerns Inventory (PCI) in disease-free, post-treatment HNC cohort. Significant pain on UW-QOL and indicating "Pain in head and neck" and "Pain elsewhere" on PCI. One hundred and seventy-seven patients completed UW-QOL and PCI. The prevalence of self-reported pain issues was 38% (67/177) comprising 25% (44/177) with significant problems despite medications and 13% (23/177) with lesser or no problems but wishing to discuss pain. Patients aged under 65 years and patients having treatment involving radiotherapy were more likely to have pain issues. Just over half, 55% (24/44) of patients with significant pain did not express a need to discuss this. Those with significant pain or others wanting to discuss pain in clinic had greater problems in physical and social-emotional functioning, reported suboptimal QOL, and also had more additional PCI items to discuss in clinic compared to those without significant pain and not wishing to discuss pain. Significant HNC-related pain is prevalent in the disease-free, posttreatment cohort. Onward referral to a specialist pain team may be beneficial. The UW-QOL and PCI package is a valuable tool that may routinely screen for significant pain in outpatient clinics.

Using routine clinical and administrative data to produce a dataset of attendances at Emergency Departments following self-harm.

PubMed

Polling, C; Tulloch, A; Banerjee, S; Cross, S; Dutta, R; Wood, D M; Dargan, P I; Hotopf, M

2015-07-16

Self-harm is a significant public health concern in the UK. This is reflected in the recent addition to the English Public Health Outcomes Framework of rates of attendance at Emergency Departments (EDs) following self-harm. However there is currently no source of data to measure this outcome. Routinely available data for inpatient admissions following self-harm miss the majority of cases presenting to services. We aimed to investigate (i) if a dataset of ED presentations could be produced using a combination of routinely collected clinical and administrative data and (ii) to validate this dataset against another one produced using methods similar to those used in previous studies. Using the Clinical Record Interactive Search system, the electronic health records (EHRs) used in four EDs were linked to Hospital Episode Statistics to create a dataset of attendances following self-harm. This dataset was compared with an audit dataset of ED attendances created by manual searching of ED records. The proportion of total cases detected by each dataset was compared. There were 1932 attendances detected by the EHR dataset and 1906 by the audit. The EHR and audit datasets detected 77% and 76 of all attendances respectively and both detected 82% of individual patients. There were no differences in terms of age, sex, ethnicity or marital status between those detected and those missed using the EHR method. Both datasets revealed more than double the number of self-harm incidents than could be identified from inpatient admission records. It was possible to use routinely collected EHR data to create a dataset of attendances at EDs following self-harm. The dataset detected the same proportion of attendances and individuals as the audit dataset, proved more comprehensive than the use of inpatient admission records, and did not show a systematic bias in those cases it missed.

Non-adherence in seniors with dementia - a serious problem of routine clinical practice.

PubMed

Lužný, Jan; Ivanová, Kateřina; Juríčková, Lubica

2014-01-01

Non-adherence to treatment in seniors with dementia is a frequent and potentially dangerous phenomenon in routine clinical practice which might lead to the inappropriate treatment of a patient, including the risk of intoxication. There might be different causes of non-adherence in patients with dementia: memory impairment, sensory disturbances, limitations in mobility, economical reasons limiting access to health care and medication. Non-adherence leads to serious clinical consequences as well as being a challenge for public health. to estimate prevalence of non-adherence in seniors with dementia and to study correlation between cognitive decline and non-adherence. Prospective study, analyzing medical records of seniors with dementia admitted to the inpatient psychogeriatric ward in the Kromeriz mental hospital from January 2010 to January 2011. Cognitive decline measured by MMSE, prevalence of Non-adherence to treatment and reasons for patient Non-adherence were studied. Non-adherence to any treatment was detected in 31.3% of seniors; memory impairment was the most common cause of non-adherence to treatment. In conclusion, non-adherence to treatment in the studied group of seniors with dementia correlates with the severity of cognitive impairment - a higher cognitive decline correlates with a higher risk of non-adherence to treatment.

Knee arthroscopy routines and practice.

PubMed

Brattwall, M; Jacobson, E; Forssblad, M; Jakobsson, J

2010-12-01

Knee arthroscopy is one of most commonly performed day-case orthopaedic procedures, thus consuming huge medical resources. The aim of the present questionnaire survey was to study knee arthroscopy routines and practice. An electronic web-based survey including questions around pre-, per- and postoperative routines for elective knee arthroscopy was send to all orthopaedic units associated to the Swedish Arthroscopic Society (n = 60). Responses covering 37 centres out of 60 (response rate 62%) were returned. Preoperative radiograph routines varied considerable between centres; conventional radiograph varied between 5 and 100% and preoperative MRI between 5 and 80% of patients. General anaesthesia was the preferred intra-operative technique used in all centres (median 79% of patients), local anaesthesia with or without light sedation was used in all 28 out of the 37 centres responding (median 10% of cases) and spinal anaesthesia was used in 15 centres (median 5% of cases). Intra-articular local anaesthesia was provided in all but one of centres. Perioperative administration of oral NSAIDs was common (31 out 37), 6 centres (all teaching hospitals) did not routinely give pre- or postoperative NSAID. Analgesic prescription was provided on a regular base in 18 (49%) of centres; an NSAID being the most commonly prescribed. All but one centre provided written information and instruction at discharge. Referral to physiotherapy, prescribed sick leave and scheduled follow-up in the outpatient clinic diverged considerably. Routines and practice associated to elective knee arthroscopy differed; however, no clear differences in practice were seen between teaching centres, general or local hospitals apart from a lower usage of NSAID for perioperative analgesia. There is an obvious room for further standardisation in the routine handling of patients undergoing elective arthroscopy of the knee.

Limited utility of routine surveillance imaging for classical Hodgkin lymphoma patients in first complete remission.

PubMed

Pingali, Sai Ravi; Jewell, Sarah W; Havlat, Luiza; Bast, Martin A; Thompson, Jonathan R; Eastwood, Daniel C; Bartlett, Nancy L; Armitage, James O; Wagner-Johnston, Nina D; Vose, Julie M; Fenske, Timothy S

2014-07-15

The objective of this study was to compare the outcomes of patients with classical Hodgkin lymphoma (cHL) who achieved complete remission with frontline therapy and then underwent either clinical surveillance or routine surveillance imaging. In total, 241 patients who were newly diagnosed with cHL between January 2000 and December 2010 at 3 participating tertiary care centers and achieved complete remission after first-line therapy were retrospectively analyzed. Of these, there were 174 patients in the routine surveillance imaging group and 67 patients in the clinical surveillance group, based on the intended mode of surveillance. In the routine surveillance imaging group, the intended plan of surveillance included computed tomography and/or positron emission tomography scans; whereas, in the clinical surveillance group, the intended plan of surveillance was clinical examination and laboratory studies, and scans were obtained only to evaluate concerning signs or symptoms. Baseline patient characteristics, prognostic features, treatment records, and outcomes were collected. The primary objective was to compare overall survival for patients in both groups. For secondary objectives, we compared the success of second-line therapy and estimated the costs of imaging for each group. After 5 years of follow-up, the overall survival rate was 97% (95% confidence interval, 92%-99%) in the routine surveillance imaging group and 96% (95% confidence interval, 87%-99%) in the clinical surveillance group (P = .41). There were few relapses in each group, and all patients who relapsed in both groups achieved complete remission with second-line therapy. The charges associated with routine surveillance imaging were significantly higher than those for the clinical surveillance strategy, with no apparent clinical benefit. Clinical surveillance was not inferior to routine surveillance imaging in patients with cHL who achieved complete remission with frontline therapy. Routine

Safety of ranibizumab in routine clinical practice: 1-year retrospective pooled analysis of four European neovascular AMD registries within the LUMINOUS programme

PubMed Central

Holz, Frank G; Bandello, Francesco; Gillies, Mark; Mitchell, Paul; Osborne, Aaron; Sheidow, Tom; Souied, Eric; Figueroa, Marta S

2013-01-01

Purpose Evaluation of 1-year safety profile of intravitreal ranibizumab 0.5 mg in neovascular age-related macular degeneration (NV-AMD) within routine clinical practice. Methods The LUMINOUS programme comprises a prospective observational study assessing ranibizumab ‘real-world’ safety and clinical effectiveness across licensed indications worldwide and an annual retrospective pooled safety analysis from completed NV-AMD ranibizumab registries. 1-year data from four European registries are available. This retrospective pooled safety analysis assessed 1-year incidence rates for safety events of particular interest (key ocular or systemic events possibly related to the injection procedure or vascular endothelial growth factor inhibition) together with treatment exposure. Patients were treated according to local protocols within the ranibizumab licence. Results Data of 4444 patients from registries in Germany (n=3470), the Netherlands (n=243), Belgium (n=260) and Sweden (n=471) were retrospectively pooled. Between 70.4% and 84.4% of enrolled patients completed 1 year of follow-up. Most frequent overall ocular events of particular interest were retinal pigment epithelial tears (27 patients; <1%) and intraocular pressure-related events (12 patients; <0.3%). Most frequent non-ocular event of particular interest was stroke (19 patients; 0.4%); annual incidence of stroke was low across all registries (0.0–0.5%). Conclusions Ranibizumab demonstrated favourable 1-year safety profile for NV-AMD in this routine clinical practice sample, consistent with previous reported trial data. Additional data from a larger patient population are needed to better describe the long-term safety profile of ranibizumab in routine clinical practice and further evaluate risk for infrequent but serious events in ‘real-life’ settings. The 5-year LUMINOUS prospective observational study will address this need. PMID:23850682

Social Withdrawal Among Individuals Receiving Psychiatric Care: Derivation of a Scale Using Routine Clinical Assessment Data to Support Screening and Outcome Measurement.

PubMed

Rios, Sebastian; Perlman, Christopher M

2017-04-24

Social withdrawal is a symptom experienced by individuals with an array of mental health conditions, particularly those with schizophrenia and mood disorders. Assessments of social withdrawal are often lengthy and may not be routinely integrated within the comprehensive clinical assessment of the individual. This study utilized item response and classical test theory methods to derive a Social Withdrawal Scale (SWS) using items embedded within a routine clinical assessment, the RAI-Mental Health (RAI-MH). Using data from 60,571 inpatients in Ontario, Canada, a common factor analysis identified seven items from the RAI-MH that measure social withdrawal. A graded response model found that six items had acceptable discrimination parameters: lack of motivation, reduced interaction, decreased energy, flat affect, anhedonia, and loss of interest. Summing these items, the SWS was found to have strong internal consistency (Cronbach's alpha = 0.82) and showed a medium to large effect size (d = 0.77) from admission to discharge. Fewer individuals with high SWS scores participated in social activity or reported having a confidant compared to those with lower scores. Since the RAI-MH is available across clinical subgroups in several jurisdictions, the SWS is a useful tool for screening, clinical decision support, and evaluation.

Clinical chemistry reference intervals of healthy adult populations in Gojjam Zones of Amhara National Regional State, Northwest Ethiopia.

PubMed

Mekonnen, Zewdie; Amuamuta, Asmare; Mulu, Wondemagegn; Yimer, Mulat; Zenebe, Yohannes; Adem, Yesuf; Abera, Bayeh; Gebeyehu, Wondemu; Gebregziabher, Yakob

2017-01-01

Reference interval is crucial for disease screening, diagnosis, monitoring, progression and treatment efficacy. Due to lack of locally derived reference values for the parameters, clinicians use reference intervals derived from western population. But, studies conducted in different African countries have indicated differences between locally and western derived reference values. Different studies also indicated considerable variation in clinical chemistry reference intervals by several variables such as age, sex, geographical location, environment, lifestyle and genetic variation. This study aimed to determine the reference intervals of common clinical chemistry parameters of the community of Gojjam Zones, Northwest Ethiopia. Population based cross-sectional study was conducted from November 2015 to December 2016 in healthy adult populations of Gojjam zone. Data such as, medical history, physical examination and socio-demographic data were collected. In addition, laboratory investigations were undertaken to screen the population. Clinical chemistry parameters were measured using Mindray BS 200 clinical chemistry autoanalyzer as per the manufacturer's instructions. Descriptive statistics was used to calculate mean, median and 95th percentiles. Independent sample T-test and one way ANOVA were used to see association between variables. After careful screening of a total of 799 apparently healthy adults who were consented for this study, complete data from 446 (224 females and 222 males) were included for the analysis. The mean age of both the study participants was 28.8 years. Males had high (P<0.05) mean and 2.5th-97.5th percentile ranges of ALT, AST, ALP, creatinine and direct bilirubin. The reference intervals of amylase, LDH, total protein and total bilirubin were not significantly different between the two sex groups (P>0.05). Mean, median, 95% percentile values of AST, ALP, amylase, LDH, creatinine, total protein, total bilirubin, and direct bilirubin across

Clinical chemistry reference intervals of healthy adult populations in Gojjam Zones of Amhara National Regional State, Northwest Ethiopia

PubMed Central

Amuamuta, Asmare; Mulu, Wondemagegn; Yimer, Mulat; Zenebe, Yohannes; Adem, Yesuf; Abera, Bayeh; Gebeyehu, Wondemu; Gebregziabher, Yakob

2017-01-01

Background Reference interval is crucial for disease screening, diagnosis, monitoring, progression and treatment efficacy. Due to lack of locally derived reference values for the parameters, clinicians use reference intervals derived from western population. But, studies conducted in different African countries have indicated differences between locally and western derived reference values. Different studies also indicated considerable variation in clinical chemistry reference intervals by several variables such as age, sex, geographical location, environment, lifestyle and genetic variation. Objective This study aimed to determine the reference intervals of common clinical chemistry parameters of the community of Gojjam Zones, Northwest Ethiopia. Method Population based cross-sectional study was conducted from November 2015 to December 2016 in healthy adult populations of Gojjam zone. Data such as, medical history, physical examination and socio-demographic data were collected. In addition, laboratory investigations were undertaken to screen the population. Clinical chemistry parameters were measured using Mindray BS 200 clinical chemistry autoanalyzer as per the manufacturer’s instructions. Descriptive statistics was used to calculate mean, median and 95th percentiles. Independent sample T-test and one way ANOVA were used to see association between variables. Results After careful screening of a total of 799 apparently healthy adults who were consented for this study, complete data from 446 (224 females and 222 males) were included for the analysis. The mean age of both the study participants was 28.8 years. Males had high (P<0.05) mean and 2.5th-97.5th percentile ranges of ALT, AST, ALP, creatinine and direct bilirubin. The reference intervals of amylase, LDH, total protein and total bilirubin were not significantly different between the two sex groups (P>0.05). Mean, median, 95% percentile values of AST, ALP, amylase, LDH, creatinine, total protein, total

Laboratory hemostasis: milestones in Clinical Chemistry and Laboratory Medicine.

PubMed

Lippi, Giuseppe; Favaloro, Emmanuel J

2013-01-01

Hemostasis is a delicate, dynamic and intricate system, in which pro- and anti-coagulant forces cooperate for either maintaining blood fluidity under normal conditions, or else will prompt blood clot generation to limit the bleeding when the integrity of blood vessels is jeopardized. Excessive prevalence of anticoagulant forces leads to hemorrhage, whereas excessive activation of procoagulant forces triggers excessive coagulation and thrombosis. The hemostasis laboratory performs a variety of first, second and third line tests, and plays a pivotal role in diagnostic and monitoring of most hemostasis disturbances. Since the leading targets of Clinical Chemistry and Laboratory Medicine include promotion of progress in fundamental and applied research, along with publication of guidelines and recommendations in laboratory diagnostics, this journal is an ideal source of information on current developments in the laboratory technology of hemostasis, and this article is aimed to celebrate some of the most important and popular articles ever published by the journal in the filed of laboratory hemostasis.

Antiretroviral Simplification with Darunavir/Ritonavir Monotherapy in Routine Clinical Practice: Safety, Effectiveness, and Impact on Lipid Profile

PubMed Central

Santos, José R.; Moltó, José; Llibre, Josep M.; Negredo, Eugenia; Bravo, Isabel; Ornelas, Arelly; Clotet, Bonaventura; Paredes, Roger

2012-01-01

Background Simplification of antiretroviral treatment (ART) with darunavir/ritonavir (DRV/r) monotherapy has achieved sustained suppression of plasma viral load (pVL) in clinical trials; however, its effectiveness and safety profile has not been evaluated in routine clinical practice. Methodology/Principal Findings We performed a retrospective cohort analysis of HIV-1-infected patients who initiated DRV/r monotherapy once daily with a pVL <50 copies/mL under ART and at least 1 subsequent follow-up visit in our clinic. The primary study endpoints were the percentage of patients with virological failure (VF, defined as 2 consecutive pVL>50 copies/mL) at week 48, and time to VF. Other causes of treatment discontinuation and changes in lipid profile were evaluated up to week 48. Ninety-two patients were followed for a median (IQR) of 73 (57–92) weeks. The median baseline and nadir CD4+ T-cell counts were 604 (433–837) and 238 (150–376) cells/mm3, respectively. Patients had previously received a median of 5 (3–9) ART lines and maintained a pVL<50 copies/mL for a median of 76 (32–176) weeks before initiating DRV/r monotherapy. Nine (9.8%) patients developed VF at week 48; time to VF was 47.1 (IQR: 36.1–47.8) weeks among patients with VF. Other reasons for changing ART were gastrointestinal disturbances (n = 3), rash (n = 1), and impaired CD4 recovery (n = 2). Median low-density lipoprotein cholesterol levels increased from 116.1 mg/dL at baseline to 137.3 mg/dL at 48 weeks (p = 0.001). Conclusions/Significance Treatment simplification with DRV/r monotherapy seems safe and effective in routine clinical practice. Further research is needed to elucidate the effect of DRV/r monotherapy on cholesterol levels. PMID:22666357

Quantitative CT characterization of pediatric lung development using routine clinical imaging

PubMed Central

Stein, Jill M.; Walkup, Laura L.; Brody, Alan S.; Fleck, Robert J.

2016-01-01

Background The use of quantitative CT analysis in children is limited by lack of normal values of lung parenchymal attenuation. These characteristics are important because normal lung development yields significant parenchymal attenuation changes as children age. Objective To perform quantitative characterization of normal pediatric lung parenchymal X-ray CT attenuation under routine clinical conditions in order to establish a baseline comparison to that seen in pathological lung conditions. Materials and methods We conducted a retrospective query of normal CT chest examinations in children ages 0–7 years from 2004 to 2014 using standard clinical protocol. During these examinations semi-automated lung parenchymal segmentation was performed to measure lung volume and mean lung attenuation. Results We analyzed 42 CT examinations in 39 children, ages 3 days to 83 months (mean ± standard deviation [SD] = 42±27 months). Lung volume ranged 0.10–1.72 liters (L). Mean lung attenuation was much higher in children younger than 12 months, with values as high as −380 Hounsfield units (HU) in neonates (lung volume 0.10 L). Lung volume decreased to approximately −650 HU by age 2 years (lung volume 0.47 L), with subsequently slower exponential decrease toward a relatively constant value of −860 HU as age and lung volume increased. Conclusion Normal lung parenchymal X-ray CT attenuation decreases with increasing lung volume and age; lung attenuation decreases rapidly in the first 2 years of age and more slowly thereafter. This change in normal lung attenuation should be taken into account as quantitative CT methods are translated to pediatric pulmonary imaging. PMID:27576458

The impact of introducing intensity modulated radiotherapy into routine clinical practice.

PubMed

Miles, Elizabeth A; Clark, Catharine H; Urbano, M Teresa Guerrero; Bidmead, Margaret; Dearnaley, David P; Harrington, Kevin J; A'Hern, Roger; Nutting, Christopher M

2005-12-01

Intensity modulated radiotherapy (IMRT) at the Royal Marsden Hospital London was introduced in July 2001. Treatment delivery was dynamic using a single-phase technique. Concerns were raised regarding increased clinical workload due to introduction of new technology. The potential increased use of resources was assessed. IMRT patient selection was within guidelines of clinical trials and included patients undergoing prostate plus pelvic lymph node (PPN) irradiation and head and neck cancer (HNC) treatment. Patient planning, quality assurance and treatment times were collected for an initial IMRT patient group. A comparative group of patients with advanced HNC undergoing two- or three-phase conventional radiotherapy, requiring matched photon and electron fields, were also timed. The median overall total planning time for IMRT was greater for HNC patients compared to the PPN cohort. For HNC the overall IMRT planning time was significantly longer than for conventional. The median treatment time for conventional two- or three-phase HNC treatments, encompassing similar volumes to those treated with IMRT, was greater than that for the IMRT HNC patient cohort. A reduction in radiographer man hours per patient of 4.8h was recorded whereas physics time was increased by 4.9h per patient. IMRT currently increases overall planning time. Additional clinician input is required for target volume localisation. Physics time is increased, a significant component of this being patient specific QA. Radiographer time is decreased. For HNC a single phase IMRT treatment has proven to be more efficient than a multiple phase conventional treatment. IMRT has been integrated smoothly and efficiently into the existing treatment working day. This preliminary study suggests that IMRT could be a routine treatment with efficient use of current radiotherapy resources.

The use of routine EEG in acute ischemic stroke patients without seizures: generalized but not focal EEG pathology is associated with clinical deterioration.

PubMed

Wolf, Marc E; Ebert, Anne D; Chatzikonstantinou, Anastasios

2017-05-01

Specialized electroencephalography (EEG) methods have been used to provide clues about stroke features and prognosis. However, the value of routine EEG in stroke patients without (suspected) seizures has been somewhat neglected. We aimed to assess this in a group of acute ischemic stroke patients in regard to short-term prognosis and basic stroke features. We assessed routine (10-20) EEG findings in 69 consecutive acute ischemic stroke patients without seizures. Associations between EEG abnormalities and NIHSS scores, clinical improvement or deterioration as well as MRI stroke characteristics were evaluated. Mean age was 69 ± 18 years, 43 of the patients (62.3%) were men. Abnormal EEG was found in 40 patients (58%) and was associated with higher age (p = 0.021). The most common EEG pathology was focal slowing (30; 43.5%). No epileptiform potentials were found. Abnormal EEG in general and generalized or focal slowing in particular was significantly associated with higher NIHSS score on admission and discharge as well as with hemorrhagic transformation of the ischemic lesion. Abnormal EEG and generalized (but not focal) slowing were associated with clinical deterioration ( p = 0.036, p = 0.003). Patients with lacunar strokes had no EEG abnormalities. Abnormal EEG in general and generalized slowing in particular are associated with clinical deterioration after acute ischemic stroke. The study demonstrates the value of routine EEG as a simple diagnostic tool in the evaluation of stroke patients especially with regard to short-term prognosis.

Reference values of amino acids and of common clinical chemistry in plasma of healthy infants aged 1 and 4 months.

PubMed

Haschke-Becher, Elisabeth; Kainz, Alexander; Bachmann, Claude

2016-01-01

To compare plasma levels of amino acids and clinical chemistry parameters in healthy infants at 1 and 4 months of age and to establish corresponding reference limits. Data of three multicenter studies assessing the safety of new infant formulas were used. During these studies infants of both age-groups were either breast-fed or received formulas of low or high protein content. All samples were analyzed centrally in the same accredited laboratory. Plasma was collected from 521 infants in total, 157 boys and 135 girls aged 1 month and 121 boys and 108 girls aged 4 months. At the age of 1 month, 62 infants had received exclusively breast milk, 198 exclusively formula, and 27 both; in the 4-months age group corresponding numbers were 49, 158 and 18, respectively; for 9 infants, diet was unknown. Concentrations of most amino acids and clinical chemistry parameters differed significantly between both ages. Regardless of age, most plasma amino acid levels were comparable or lower in breast-fed than in formula-fed infants whereas at 1 month of age most clinical chemistry parameters were higher. While in breast-fed infants the plasma urea concentration decreased over 4 months of age, it increased in formula-fed infants. There were significant differences between infants fed a low and high protein formula. At both ages, high protein formulas resulted in significantly higher threonine, 2-aminobutyrate, and urea concentrations. For clinical use, age- and diet specific reference limits in infants are warranted.

Clinical chemistry and hematology values in a Caribbean population of African green monkeys.

PubMed

Liddie, Shervin; Goody, Robin J; Valles, Rodrigo; Lawrence, Matthew S

2010-12-01

Hematology and clinical chemistry (HCC) reference values are critical in veterinary practice and in vivo pre-clinical research, enabling detection of health abnormalities, response to therapeutic intervention or adverse toxicological effects, as well as monitoring of clinical management. In this report, reference ranges for 46 HCC parameters were characterized in 331 wild-caught and colony-bred African green monkeys. Effects of sex, weight and duration of captivity were determined by one-way analysis of variance. Significant sex differences were observed for several HCC parameters. Significant differences were also observed for select HCC variables between newly caught animals and those held in captivity for 1-12 months or longer. Comparison of this data with other non-human primate species and humans highlights similarities and disparities between species. Potential causes of interpopulation variability and relevance to the use of the African green monkey as a non-human primate model are discussed. © 2010 John Wiley & Sons A/S.

A new SPECT/CT reconstruction algorithm: reliability and accuracy in clinical routine for non-oncologic bone diseases.

PubMed

Delcroix, Olivier; Robin, Philippe; Gouillou, Maelenn; Le Duc-Pennec, Alexandra; Alavi, Zarrin; Le Roux, Pierre-Yves; Abgral, Ronan; Salaun, Pierre-Yves; Bourhis, David; Querellou, Solène

2018-02-12

xSPECT Bone® (xB) is a new reconstruction algorithm developed by Siemens® in bone hybrid imaging (SPECT/CT). A CT-based tissue segmentation is incorporated into SPECT reconstruction to provide SPECT images with bone anatomy appearance. The objectives of this study were to assess xB/CT reconstruction diagnostic reliability and accuracy in comparison with Flash 3D® (F3D)/CT in clinical routine. Two hundred thirteen consecutive patients referred to the Brest Nuclear Medicine Department for non-oncological bone diseases were evaluated retrospectively. Two hundred seven SPECT/CT were included. All SPECT/CT were independently interpreted by two nuclear medicine physicians (a junior and a senior expert) with xB/CT then with F3D/CT three months later. Inter-observer agreement (IOA) and diagnostic confidence were determined using McNemar test, and unweighted Kappa coefficient. The study objectives were then re-assessed for validation through > 18 months of clinical and paraclinical follow-up. No statistically significant differences between IOA xB and IOA F3D were found (p = 0.532). Agreement for xB after categorical classification of the diagnoses was high (κ xB = 0.89 [95% CI 0.84 -0.93]) but without statistically significant difference F3D (κ F3D = 0.90 [95% CI 0.86 - 0.94]). Thirty-one (14.9%) inter-reconstruction diagnostic discrepancies were observed of which 21 (10.1%) were classified as major. The follow-up confirmed the diagnosis of F3D in 10 cases, xB in 6 cases and was non-contributory in 5 cases. xB reconstruction algorithm was found reliable, providing high interobserver agreement and similar diagnostic confidence to F3D reconstruction in clinical routine.

Lesson Unplanning: Toward Transforming Routine Tasks into Non-Routine Problems

ERIC Educational Resources Information Center

Beghetto, Ronald A.

2017-01-01

How might teachers transform routine tasks into non-routine ones? The purpose of this article is to address this question. The article opens with a discussion of why non-routine problems require creative and original thought. Specifically, I discuss how non-routine problems require students to confront uncertainty and how uncertainty can serve as…

The clinical impact of using complex molecular profiling strategies in routine oncology practice.

PubMed

Laes, Jean-François; Aftimos, Philippe; Barthelemy, Philippe; Bellmunt, Joaquim; Berchem, Guy; Camps, Carlos; Peñas, Ramón de Las; Finzel, Ana; García-Foncillas, Jesús; Hervonen, Petteri; Wahid, Ibrahim; Joensuu, Timo; Kathan, Louis; Kong, Anthony; Mackay, James; Mikropoulos, Christos; Mokbel, Kefah; Mouysset, Jean-Loup; Odarchenko, Sergey; Perren, Timothy J; Pienaar, Rika; Regonesi, Carlos; Alkhayyat, Shadi Salem; El Kinge, Abdul Rahman; Abulkhair, Omalkhair; Galal, Khaled Morsi; Ghanem, Hady; El Karak, Fadi; Garcia, Angel; Ghitti, Gregori; Sadik, Helen

2018-04-17

Molecular profiling and functional assessment of signalling pathways of advanced solid tumours are becoming increasingly available. However, their clinical utility in guiding patients' treatment remains unknown. Here, we assessed whether molecular profiling helps physicians in therapeutic decision making by analysing the molecular profiles of 1057 advanced cancer patient samples after failing at least one standard of care treatment using a combination of next-generation sequencing (NGS), immunohistochemistry (IHC) and other specific tests. The resulting information was interpreted and personalized treatments for each patient were suggested. Our data showed that NGS alone provided the oncologist with useful information in 10-50% of cases (depending on cancer type), whereas the addition of IHC/other tests increased extensively the usefulness of the information provided. Using internet surveys, we investigated how therapy recommendations influenced treatment choice of the oncologist. For patients who were still alive after the provision of the molecular information (76.8%), 60.4% of their oncologists followed report recommendations. Most treatment decisions (93.4%) were made based on the combination of NGS and IHC/other tests, and an approved drug- rather than clinical trial enrolment- was the main treatment choice. Most common reasons given by physicians to explain the non-adherence to recommendations were drug availability and cost, which remain barriers to personalised precision medicine. Finally, we observed that 27% of patients treated with the suggested therapies had an overall survival > 12 months. Our study demonstrates that the combination of NGS and IHC/other tests provides the most useful information in aiding treatment decisions by oncologists in routine clinical practice.

Process mining routinely collected electronic health records to define real-life clinical pathways during chemotherapy.

PubMed

Baker, Karl; Dunwoodie, Elaine; Jones, Richard G; Newsham, Alex; Johnson, Owen; Price, Christopher P; Wolstenholme, Jane; Leal, Jose; McGinley, Patrick; Twelves, Chris; Hall, Geoff

2017-07-01

There is growing interest in the use of routinely collected electronic health records to enhance service delivery and facilitate clinical research. It should be possible to detect and measure patterns of care and use the data to monitor improvements but there are methodological and data quality challenges. Driven by the desire to model the impact of a patient self-test blood count monitoring service in patients on chemotherapy, we aimed to (i) establish reproducible methods of process-mining electronic health records, (ii) use the outputs derived to define and quantify patient pathways during chemotherapy, and (iii) to gather robust data which is structured to be able to inform a cost-effectiveness decision model of home monitoring of neutropenic status during chemotherapy. Electronic Health Records at a UK oncology centre were included if they had (i) a diagnosis of metastatic breast cancer and received adjuvant epirubicin and cyclosphosphamide chemotherapy or (ii) colorectal cancer and received palliative oxaliplatin and infusional 5-fluorouracil chemotherapy, and (iii) were first diagnosed with cancer between January 2004 and February 2013. Software and a Markov model were developed, producing a schematic of patient pathways during chemotherapy. Significant variance from the assumed care pathway was evident from the data. Of the 535 patients with breast cancer and 420 with colorectal cancer there were 474 and 329 pathway variants respectively. Only 27 (5%) and 26 (6%) completed the planned six cycles of chemotherapy without having unplanned hospital contact. Over the six cycles, 169 (31.6%) patients with breast cancer and 190 (45.2%) patients with colorectal cancer were admitted to hospital. The pathways of patients on chemotherapy are complex. An iterative approach to addressing semantic and data quality issues enabled the effective use of routinely collected patient records to produce accurate models of the real-life experiences of chemotherapy patients and

Implementation of a successful on-call system in clinical chemistry.

PubMed

Hobbs, G A; Jortani, S A; Valdes, R

1997-11-01

Successful practice of clinical pathology depends on a wide variety of laboratory, clinical, and managerial decisions. The skills needed to make these decisions can most effectively be learned by residents and fellows in pathology using a service-oriented on-call approach. We report our experience implementing an on-call system in the clinical chemistry laboratory at the University of Louisville Hospital (Ky). We detail the guidelines used to establish this system and the elements required for its successful implementation. The system emphasizes a laboratory-initiated approach to linking laboratory results to patient care. From inception of the program during late 1990 through 1995, the number of beeper calls (including clinician contacts) steadily increased and is currently 8 to 20 per week. The on-call system is active 24 hours per day, 7 days per week, thus representing activity on all three laboratory shifts. Types of responses were separated into administrative (12%), analytical (42%), clinical (63%), quality control or quality assurance (12%), and consultation (13%) categories. We also present 6 case reports as examples demonstrating multiple elements in these categories. In 23% of the calls, clinician contact was required and achieved by the fellow or resident on call for the laboratory. The on-call reports are documented and presented informally at weekly on-call report sessions. Emphasis is placed on learning and refinement of investigative skills needed to function as an effective laboratory director. Educational emphasis for the medical staff is in establishing awareness of the presence of the laboratory as an important interactive component of patient care. In addition, we found this program to be beneficial to the hospital and to the department of pathology in fulfilling its clinical service and teaching missions. Our experience may be helpful to other institutions establishing such a program.

Effect of On-Demand vs Routine Nebulization of Acetylcysteine With Salbutamol on Ventilator-Free Days in Intensive Care Unit Patients Receiving Invasive Ventilation: A Randomized Clinical Trial.

PubMed

van Meenen, David M P; van der Hoeven, Sophia M; Binnekade, Jan M; de Borgie, Corianne A J M; Merkus, Maruschka P; Bosch, Frank H; Endeman, Henrik; Haringman, Jasper J; van der Meer, Nardo J M; Moeniralam, Hazra S; Slabbekoorn, Mathilde; Muller, Marcella C A; Stilma, Willemke; van Silfhout, Bart; Neto, Ary Serpa; Ter Haar, Hans F M; Van Vliet, Jan; Wijnhoven, Jan Willem; Horn, Janneke; Juffermans, Nicole P; Pelosi, Paolo; Gama de Abreu, Marcelo; Schultz, Marcus J; Paulus, Frederique

2018-03-13

It remains uncertain whether nebulization of mucolytics with bronchodilators should be applied for clinical indication or preventively in intensive care unit (ICU) patients receiving invasive ventilation. To determine if a strategy that uses nebulization for clinical indication (on-demand) is noninferior to one that uses preventive (routine) nebulization. Randomized clinical trial enrolling adult patients expected to need invasive ventilation for more than 24 hours at 7 ICUs in the Netherlands. On-demand nebulization of acetylcysteine or salbutamol (based on strict clinical indications, n = 471) or routine nebulization of acetylcysteine with salbutamol (every 6 hours until end of invasive ventilation, n = 473). The primary outcome was the number of ventilator-free days at day 28, with a noninferiority margin for a difference between groups of -0.5 days. Secondary outcomes included length of stay, mortality rates, occurrence of pulmonary complications, and adverse events. Nine hundred twenty-two patients (34% women; median age, 66 (interquartile range [IQR], 54-75 years) were enrolled and completed follow-up. At 28 days, patients in the on-demand group had a median 21 (IQR, 0-26) ventilator-free days, and patients in the routine group had a median 20 (IQR, 0-26) ventilator-free days (1-sided 95% CI, -0.00003 to ∞). There was no significant difference in length of stay or mortality, or in the proportion of patients developing pulmonary complications, between the 2 groups. Adverse events (13.8% vs 29.3%; difference, -15.5% [95% CI, -20.7% to -10.3%]; P < .001) were more frequent with routine nebulization and mainly related to tachyarrhythmia (12.5% vs 25.9%; difference, -13.4% [95% CI, -18.4% to -8.4%]; P < .001) and agitation (0.2% vs 4.3%; difference, -4.1% [95% CI, -5.9% to -2.2%]; P < .001). Among ICU patients receiving invasive ventilation who were expected to not be extubated within 24 hours, on-demand compared with routine nebulization of

Training clinicians in how to use patient-reported outcome measures in routine clinical practice.

PubMed

Santana, Maria J; Haverman, Lotte; Absolom, Kate; Takeuchi, Elena; Feeny, David; Grootenhuis, Martha; Velikova, Galina

2015-07-01

Patient-reported outcome measures (PROs) were originally developed for comparing groups of people in clinical trials and population studies, and the results were used to support treatment recommendations or inform health policy, but there was not direct benefit for the participants providing PROs data. However, as the experience in using those measures increased, it became obvious the clinical value in using individual patient PROs profiles in daily practice to identify/monitor symptoms, evaluate treatment outcomes and support shared decision-making. A key issue limiting successful implementation is clinicians' lack of knowledge on how to effectively utilize PROs data in their clinical encounters. Using a change management theoretical framework, this paper describes the development and implementation of three programs for training clinicians to effectively use PRO data in routine practice. The training programs are in three diverse clinical areas (adult oncology, lung transplant and paediatrics), in three countries with different healthcare systems, thus providing a rare opportunity to pull out common approaches whilst recognizing specific settings. For each program, we describe the clinical and organizational setting, the program planning and development, the content of the training session with supporting material, subsequent monitoring of PROs use and evidence of adoption. The common successful components and practical steps are identified, leading to discussion and future recommendations. The results of the three training programs are described as the implementation. In the oncology program, PRO data have been developed and are currently evaluated; in the lung transplant program, PRO data are used in daily practice and the integration with electronic patient records is under development; and in the paediatric program, PRO data are fully implemented with around 7,600 consultations since the start of the implementation. Adult learning programs teaching clinicians

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

PubMed Central

2013-01-01

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

An estimation of the clinical mastitis incidence per 100 cows per year based on routinely collected herd data.

PubMed

Santman-Berends, I M G A; Lam, T J G M; Keurentjes, J; van Schaik, G

2015-10-01

The aim of this study was to evaluate whether it was possible to (1) estimate the clinical mastitis incidence rate (CMI) for all Dutch dairy herds and (2) to detect farms with a high CMI based on routinely collected herd data. For this study, 240 dairy farms with a conventional milking system that participated in the milk recording program every 4 to 6 wk were randomly selected and agreed to participate. From the initial 240 herds, data of clinical mastitis (CM) registrations and routinely collected herd data of 227 herds were complete and could be used for analysis. Routinely collected herd data consisted of identification and registration records, antimicrobial usage, test-day records from the milk recording program, bulk tank milk (BTM) somatic cell count data and results of diagnostic tests on BTM samples. For each of the 227 herds, the CMI per 100 cows per year was calculated per quarter of the year and was combined with the available herd data. Two models were developed to predict the CMI for all dairy herds and to detect individual herds that belonged to the 25% herds with the highest CMI. Records of 156 (67%) herds were used for development of the models and the remaining 71 (33%) were used for validation. The model that estimated the CMI in all herds consisted of 11 explanatory variables. The observed and predicted averages of the validation herds were not significantly different. The model estimated a CMI per 100 cows per year of 32.5 cases (95% confidence interval=30.2-34.8), whereas the farmers registered 33.4 cases (95% confidence interval=29.5-37.4). The model that aimed at detecting individual herds with a high CMI contained 6 explanatory variables and could correctly classify 77% of all validation herds at the quarter-year level. The most important variables in the model were antibiotic usage for treating CM and BTM somatic cell count. In conclusion, models based on routinely collected herd data gave an accurate prediction of CMI for all Dutch dairy

Development and Validation of the Pediatric Diabetes Routines Questionnaire for Adolescents.

PubMed

Pierce, Jessica S; Jordan, Sara S; Arnau, Randolph C

2018-04-06

This study describes the development and psychometric evaluation of an adolescent self-report version of the Pediatric Diabetes Routines Questionnaire (PDRQ:A), a measure of diabetes-specific routines for youth with type 1 diabetes, and further validation of the parent-version (PDRQ:P) in an adolescent sample. Participants included 120 parent-adolescent dyads (ages 12-17) and an additional 24 parents who completed measures of diabetes-specific adolescent routines, general adolescent routines, diabetes self-care, and family support of youth diabetes care. The PDRQ:P/A demonstrated good internal consistency, test-retest reliability, and parent-child agreement, and adequate validity coefficients. Confirmatory factor analysis supported a one-factor model. Promising results were obtained. The PDRQ:P/A is a clinically feasible parent- and self-report measure that can provide valuable information regarding how frequently adolescents engage in their diabetes management tasks in a consistent manner. Addition of an adolescent report format will enhance the utility of the measure for clinical and research use.

[Big data from clinical routine].

PubMed

Mansmann, U

2018-04-01

Over the past 100 years, evidence-based medicine has undergone several fundamental changes. Through the field of physiology, medical doctors were introduced to the natural sciences. Since the late 1940s, randomized and epidemiological studies have come to provide the evidence for medical practice, which led to the emergence of clinical epidemiology as a new field in the medical sciences. Within the past few years, big data has become the driving force behind the vision for having a comprehensive set of health-related data which tracks individual healthcare histories and consequently that of large populations. The aim of this article is to discuss the implications of data-driven medicine, and to examine how it can find a place within clinical care. The EU-wide discussion on the development of data-driven medicine is presented. The following features and suggested actions were identified: harmonizing data formats, data processing and analysis, data exchange, related legal frameworks and ethical challenges. For the effective development of data-driven medicine, pilot projects need to be conducted to allow for open and transparent discussion on the advantages and challenges. The Federal Ministry of Education and Research ("Bundesministerium für Bildung und Forschung," BMBF) Arthromark project is an important example. Another example is the Medical Informatics Initiative of the BMBF. The digital revolution affects clinic practice. Data can be generated and stored in quantities that are almost unimaginable. It is possible to take advantage of this for development of a learning healthcare system if the principles of medical evidence generation are integrated into innovative IT-infrastructures and processes.

Developing everyday routines.

PubMed

McNamara, Paula; Humphry, Ruth

2008-05-01

This study obtains a deeper understanding of the processes supporting the formation of young children's routines in a child care classroom. Eight infants and toddlers and their teachers from two child care classrooms were observed for 4 to 6 months during periods of regularly occurring activities. Detailed, moment-to-moment descriptions of their behaviors and interactions were analyzed. Eleven processes supported the development of children's routines. Teachers structured and guided the children's experiences in learning routines, and children initiated requests to do routines. The study also identified three processes where children invited, coached, and modeled, supporting one another in learning routines. Finally, familiar objects used in routines elicited the children's engagement.

Practical issues in implementing whole-genome-sequencing in routine diagnostic microbiology.

PubMed

Rossen, J W A; Friedrich, A W; Moran-Gilad, J

2018-04-01

Next generation sequencing (NGS) is increasingly being used in clinical microbiology. Like every new technology adopted in microbiology, the integration of NGS into clinical and routine workflows must be carefully managed. To review the practical aspects of implementing bacterial whole genome sequencing (WGS) in routine diagnostic laboratories. Review of the literature and expert opinion. In this review, we discuss when and how to integrate whole genome sequencing (WGS) in the routine workflow of the clinical laboratory. In addition, as the microbiology laboratories have to adhere to various national and international regulations and criteria for their accreditation, we deliberate on quality control issues for using WGS in microbiology, including the importance of proficiency testing. Furthermore, the current and future place of this technology in the diagnostic hierarchy of microbiology is described as well as the necessity of maintaining backwards compatibility with already established methods. Finally, we speculate on the question of whether WGS can entirely replace routine microbiology in the future and the tension between the fact that most sequencers are designed to process multiple samples in parallel whereas for optimal diagnosis a one-by-one processing of the samples is preferred. Special reference is made to the cost and turnaround time of WGS in diagnostic laboratories. Further development is required to improve the workflow for WGS, in particular to shorten the turnaround time, reduce costs, and streamline downstream data analyses. Only when these processes reach maturity will reliance on WGS for routine patient management and infection control management become feasible, enabling the transformation of clinical microbiology into a genome-based and personalized diagnostic field. Copyright © 2017 The Author(s). Published by Elsevier Ltd.. All rights reserved.

Next-generation sequencing strategies enable routine detection of balanced chromosome rearrangements for clinical diagnostics and genetic research.

PubMed

Talkowski, Michael E; Ernst, Carl; Heilbut, Adrian; Chiang, Colby; Hanscom, Carrie; Lindgren, Amelia; Kirby, Andrew; Liu, Shangtao; Muddukrishna, Bhavana; Ohsumi, Toshiro K; Shen, Yiping; Borowsky, Mark; Daly, Mark J; Morton, Cynthia C; Gusella, James F

2011-04-08

The contribution of balanced chromosomal rearrangements to complex disorders remains unclear because they are not detected routinely by genome-wide microarrays and clinical localization is imprecise. Failure to consider these events bypasses a potentially powerful complement to single nucleotide polymorphism and copy-number association approaches to complex disorders, where much of the heritability remains unexplained. To capitalize on this genetic resource, we have applied optimized sequencing and analysis strategies to test whether these potentially high-impact variants can be mapped at reasonable cost and throughput. By using a whole-genome multiplexing strategy, rearrangement breakpoints could be delineated at a fraction of the cost of standard sequencing. For rearrangements already mapped regionally by karyotyping and fluorescence in situ hybridization, a targeted approach enabled capture and sequencing of multiple breakpoints simultaneously. Importantly, this strategy permitted capture and unique alignment of up to 97% of repeat-masked sequences in the targeted regions. Genome-wide analyses estimate that only 3.7% of bases should be routinely omitted from genomic DNA capture experiments. Illustrating the power of these approaches, the rearrangement breakpoints were rapidly defined to base pair resolution and revealed unexpected sequence complexity, such as co-occurrence of inversion and translocation as an underlying feature of karyotypically balanced alterations. These findings have implications ranging from genome annotation to de novo assemblies and could enable sequencing screens for structural variations at a cost comparable to that of microarrays in standard clinical practice. Copyright © 2011 The American Society of Human Genetics. Published by Elsevier Inc. All rights reserved.

Imaging tests in staging and surveillance of non-metastatic breast cancer: changes in routine clinical practice and cost implications.

PubMed

De Placido, S; De Angelis, C; Giuliano, M; Pizzi, C; Ruocco, R; Perrone, V; Bruzzese, D; Tommasielli, G; De Laurentiis, M; Cammarota, S; Arpino, G; Arpino, G

2017-03-14

Although guidelines do not recommend computerised tomography (CT), positron emission tomography (PET) or magnetic resonance imaging (MRI) for the staging or follow-up of asymptomatic patients with non-metastatic breast cancer, they are often requested in routine clinical practice. The aim of this study was to determine the staging and follow-up patterns, and relative costs in a large population of breast cancer patients living and treated in a Southern Italian region. We analysed the clinical computerised information recorded by 567 primary-care physicians assisting about 650 000 inhabitants in the Campania region. Patients with non-metastatic breast cancer were identified and divided into calendar years from 2001 to 2010. The number of diagnostic tests prescribed per 100 patients (N/Pts) and the mean cost per patient was determined 3 months before diagnosis and up to 1 year after diagnosis. Costs are expressed in constant 2011 euros. We identified 4680 newly diagnosed cases of asymptomatic non-metastatic breast cancer. N/Pts increased significantly (P<0.0001) from 2001 to 2010. The mean number of prescribed mammograms, bone scans, abdominal ultrasound and chest X-rays ('routine tests'), and costs was unchanged. However, the number of CT, PET scans and MRI ('new tests')prescriptions almost quadrupled and the mean cost per patient related to these procedures significantly increased from [euro ]357 in 2001 to [euro ]830 in 2010 (P<0.0001). New test prescriptions and relative costs significantly and steadily increased throughout the study period. At present there is no evidence that the delivery of new tests to asymptomatic patients improves breast cancer outcome. Well-designed clinical trials are urgently needed to shed light on the impact of these tests on clinical outcome and overall survival.

A clinical perspective on the 2016 WHO brain tumor classification and routine molecular diagnostics.

PubMed

van den Bent, Martin J; Weller, Michael; Wen, Patrick Y; Kros, Johan M; Aldape, Ken; Chang, Susan

2017-05-01

The 2007 World Health Organization (WHO) classification of brain tumors did not use molecular abnormalities as diagnostic criteria. Studies have shown that genotyping allows a better prognostic classification of diffuse glioma with improved treatment selection. This has resulted in a major revision of the WHO classification, which is now for adult diffuse glioma centered around isocitrate dehydrogenase (IDH) and 1p/19q diagnostics. This revised classification is reviewed with a focus on adult brain tumors, and includes a recommendation of genes of which routine testing is clinically useful. Apart from assessment of IDH mutational status including sequencing of R132H-immunohistochemistry negative cases and testing for 1p/19q, several other markers can be considered for routine testing, including assessment of copy number alterations of chromosome 7 and 10 and of TERT promoter, BRAF, and H3F3A mutations. For "glioblastoma, IDH mutated" the term "astrocytoma grade IV" could be considered. It should be considered to treat IDH wild-type grades II and III diffuse glioma with polysomy of chromosome 7 and loss of 10q as glioblastoma. New developments must be more quickly translated into further revised diagnostic categories. Quality control and rapid integration of molecular findings into the final diagnosis and the communication of the final diagnosis to clinicians require systematic attention. © The Author(s) 2017. Published by Oxford University Press on behalf of the Society for Neuro-Oncology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Brief sexual histories and routine HIV/STD testing by medical providers.

PubMed

Lanier, Yzette; Castellanos, Ted; Barrow, Roxanne Y; Jordan, Wilbert C; Caine, Virginia; Sutton, Madeline Y

2014-03-01

Clinicians who routinely take patient sexual histories have the opportunity to assess patient risk for sexually transmitted diseases (STDs), including human immunodeficiency virus (HIV), and make appropriate recommendations for routine HIV/STD screenings. However, less than 40% of providers conduct sexual histories with patients, and many do not receive formal sexual history training in school. After partnering with a national professional organization of physicians, we trained 26 (US and US territory-based) practicing physicians (58% female; median age=48 years) regarding sexual history taking using both in-person and webinar methods. Trainings occurred during either a 6-h onsite or 2-h webinar session. We evaluated their post-training experiences integrating sexual histories during routine medical visits. We assessed use of sexual histories and routine HIV/STD screenings. All participating physicians reported improved sexual history taking and increases in documented sexual histories and routine HIV/STD screenings. Four themes emerged from the qualitative evaluations: (1) the need for more sexual history training; (2) the importance of providing a gender-neutral sexual history tool; (3) the existence of barriers to routine sexual histories/testing; and (4) unintended benefits for providers who were conducting routine sexual histories. These findings were used to develop a brief, gender-neutral sexual history tool for clinical use. This pilot evaluation demonstrates that providers were willing to utilize a sexual history tool in clinical practice in support of HIV/STD prevention efforts.

Brief Sexual Histories and Routine HIV/STD Testing by Medical Providers

PubMed Central

Lanier, Yzette; Castellanos, Ted; Barrow, Roxanne Y.; Jordan, Wilbert C.; Caine, Virginia

2014-01-01

Abstract Clinicians who routinely take patient sexual histories have the opportunity to assess patient risk for sexually transmitted diseases (STDs), including human immunodeficiency virus (HIV), and make appropriate recommendations for routine HIV/STD screenings. However, less than 40% of providers conduct sexual histories with patients, and many do not receive formal sexual history training in school. After partnering with a national professional organization of physicians, we trained 26 (US and US territory-based) practicing physicians (58% female; median age=48 years) regarding sexual history taking using both in-person and webinar methods. Trainings occurred during either a 6-h onsite or 2-h webinar session. We evaluated their post-training experiences integrating sexual histories during routine medical visits. We assessed use of sexual histories and routine HIV/STD screenings. All participating physicians reported improved sexual history taking and increases in documented sexual histories and routine HIV/STD screenings. Four themes emerged from the qualitative evaluations: (1) the need for more sexual history training; (2) the importance of providing a gender-neutral sexual history tool; (3) the existence of barriers to routine sexual histories/testing; and (4) unintended benefits for providers who were conducting routine sexual histories. These findings were used to develop a brief, gender-neutral sexual history tool for clinical use. This pilot evaluation demonstrates that providers were willing to utilize a sexual history tool in clinical practice in support of HIV/STD prevention efforts. PMID:24564387

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).

Chapter IX. Bedtime Routines in Toddlerhood: Prevalence, Consistency, and Associations with Nighttime Sleep

PubMed Central

Staples, Angela D.; Bates, John E.; Petersen, Isaac T.

2016-01-01

The ability to transition from wakefulness to sleep is one of the most important tasks in the development of sleep during early childhood. Although establishing regular bedtime routines for children with sleep problems can be clinically effective in reducing the number of signaled night awakenings and increasing amounts of sleep, it is unclear whether a regular bedtime routine would be associated with either the frequency of signaled night awakenings or nightly sleep minutes in a non-clinical sample of children. This study examined the role of a regular bedtime routine on the development of sleep regulation and consolidation in a community sample of young children. Adherence to a bedtime routine was concurrently associated with a greater amount of nightly sleep at 36 and 42 months. In addition, adherence to a bedtime routine predicted an increase in nightly sleep minutes over a six-month period. Finally, this study demonstrated that adherence to a bedtime routine was particularly supportive of developmental gains for children of mothers who used consistent parenting practices during the day. PMID:25704740

Art, auto-mechanics, and supramolecular chemistry. A merging of hobbies and career.

PubMed

Anslyn, Eric V

2016-01-01

While the strict definition of supramolecular chemistry is "chemistry beyond the molecule", meaning having a focus on non-covalent interactions, the field is primarily associated with the creation of synthetic receptors and self-assembly. For synthetic ease, the receptors and assemblies routinely possess a high degree of symmetry, which lends them an aspect of aesthetic beauty. Pictures of electron orbitals similarly can be seen as akin to works of art. This similarity was an early draw for me to the fields of supramolecular chemistry and molecular orbital theory, because I grew up in a household filled with art. In addition to art, my childhood was filled with repairing and constructing mechanical entities, such as internal combustion motors, where many components work together to achieve a function. Analogously, the field of supramolecular chemistry creates systems of high complexity that achieve functions or perform tasks. Therefore, in retrospect a career in supramolecular chemistry appears to be simply an extension of childhood hobbies involving art and auto-mechanics.

Systematic Reviews Published in Emergency Medicine Journals Do Not Routinely Search Clinical Trials Registries: A Cross-Sectional Analysis.

PubMed

Keil, Lukas G; Platts-Mills, Timothy F; Jones, Christopher W

2015-10-01

Publication bias compromises the validity of systematic reviews. This problem can be addressed in part through searching clinical trials registries to identify unpublished studies. This study aims to determine how often systematic reviews published in emergency medicine journals include clinical trials registry searches. We identified all systematic reviews published in the 6 highest-impact emergency medicine journals between January 1 and December 31, 2013. Systematic reviews that assessed the effects of an intervention were further examined to determine whether the authors described searching a clinical trials registry and whether this search identified relevant unpublished studies. Of 191 articles identified through PubMed search, 80 were confirmed to be systematic reviews. Our sample consisted of 41 systematic reviews that assessed a specific intervention. Eight of these 41 (20%) searched a clinical trials registry. For 4 of these 8 reviews, the registry search identified at least 1 relevant unpublished study. Systematic reviews published in emergency medicine journals do not routinely include searches of clinical trials registries. By helping authors identify unpublished trial data, the addition of registry searches may improve the validity of systematic reviews. Copyright © 2014 American College of Emergency Physicians. Published by Elsevier Inc. All rights reserved.

Pharmacovigilance during ibrutinib therapy for chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) in routine clinical practice.

PubMed

Finnes, Heidi D; Chaffee, Kari G; Call, Timothy G; Ding, Wei; Kenderian, Saad S; Bowen, Deborah A; Conte, Michael; McCullough, Kristen B; Merten, Julianna A; Bartoo, Gabriel T; Smith, Matthew D; Leis, Jose; Chanan-Khan, Asher; Schwager, Susan M; Slager, Susan L; Kay, Neil E; Shanafelt, Tait D; Parikh, Sameer A

2017-06-01

Due to Cytochrome P450 3A (CYP3A) metabolism, clinical trials of ibrutinib-treated chronic lymphocytic leukemia (CLL) patients prohibited concurrent medications metabolized by CYP3A. We evaluated concomitant medication use in 118 ibrutinib-treated CLL patients outside the context of clinical trials. Seventy-five (64%) patients were on medications that could increase ibrutinib toxicity and 4 (3%) were on drugs that could decrease ibrutinib efficacy. Nineteen (16%) patients were on concomitant CYP3A inhibitors (11 moderate, 8 strong), and 4 (3%) were on CYP3A inducers (two patients were on both CYP3A inhibitors and inducers). Although the ibrutinib starting dose was changed in 18 patients on CYP3A interacting medications, no difference in 18-month progression-free survival or rate of ibrutinib discontinuation was observed in patients who were not. In routine clinical practice, 2 of 3 CLL patients commencing ibrutinib are on a concomitant medication with potential to influence ibrutinib metabolism. Formal medication review by a pharmacist should be considered in all patients initiating ibrutinib.

Feasibility of applying data mining techniques for predicting technical difficulties during laparoscopic cholecystectomy based on routine patient work-up in a small community hospital.

PubMed

Stanisic, Veselin; Andjelkovic, Igor; Vlaovic, Darko; Babic, Igor; Kocev, Nikola; Nikolic, Bosko; Milicevic, Miroslav

2013-10-01

Predicting technical difficulties in laparoscopic cholecystectomy (LC) in a small regional hospital increases efficacy, cost-benefit and safety of the procedure. The aim of the study was to assess whether it is possible to accurately predict a difficult LC (DLC) in a small regional hospital based only on the routine available clinical work-up parameters (patient history, ultrasound examination and blood chemistry) and their combinations. A prospective, cohort, of 369 consecutive patients operated by the same surgeon was analyzed. Conversion rate was 10 (2.7%). DLC was registered in 55 (14.90%). Various data mining techniques were applied and assessed. Seven significant predictors of DLC were identified: i) shrunken (fibrotic) gallbladder (GB); ii) ultrasound (US) GB wall thickness >4 mm; iii) >5 attacks of pain lasting >5 hours; iv) WBC >10x109 g/L; v) pericholecystic fluid; vi) urine amylase >380 IU/L, and vii) BMI >30kg/m2. Bayesian network was selected as the best classifier with accuracy of 94.57, specificity 0.98, sensitivity 0.77, AUC 0.96 and F-measure 0.81. It is possible to predict a DLC with high accuracy using data mining techniques, based on routine preoperative clinical parameters and their combinations. Use of sophisticated diagnostic equipment is not necessary.

"There are too many, but never enough": qualitative case study investigating routine coding of clinical information in depression.

PubMed

Cresswell, Kathrin; Morrison, Zoe; Kalra, Dipak; Sheikh, Aziz

2012-01-01

We sought to understand how clinical information relating to the management of depression is routinely coded in different clinical settings and the perspectives of and implications for different stakeholders with a view to understanding how these may be aligned. Qualitative investigation exploring the views of a purposefully selected range of healthcare professionals, managers, and clinical coders spanning primary and secondary care. Our dataset comprised 28 semi-structured interviews, a focus group, documents relating to clinical coding standards and participant observation of clinical coding activities. We identified a range of approaches to coding clinical information including templates and order entry systems. The challenges inherent in clearly establishing a diagnosis, identifying appropriate clinical codes and possible implications of diagnoses for patients were particularly prominent in primary care. Although a range of managerial and research benefits were identified, there were no direct benefits from coded clinical data for patients or professionals. Secondary care staff emphasized the role of clinical coders in ensuring data quality, which was at odds with the policy drive to increase real-time clinical coding. There was overall no evidence of clear-cut direct patient care benefits to inform immediate care decisions, even in primary care where data on patients with depression were more extensively coded. A number of important secondary uses were recognized by healthcare staff, but the coding of clinical data to serve these ends was often poorly aligned with clinical practice and patient-centered considerations. The current international drive to encourage clinical coding by healthcare professionals during the clinical encounter may need to be critically examined.

Absence of Decline of Kidney Function in Human Immunodeficiency Virus-Infected Patients Under Routine Clinical Management.

PubMed

Boucquemont, Julie; Lawson-Ayayi, Sylvie; Rigothier, Claire; Bonnet, Fabrice; Proust-Lima, Cécile; Neau, Didier; Greib, Carine; Miremont-Salamé, Ghada; Dabis, François; Dupon, Michel; Dauchy, Frédéric-Antoine

2017-01-01

Since the introduction of antiretroviral therapy (ART), human immunodeficiency virus (HIV)-infected patients have a drastically improved prognosis but at the same time they are also more affected by non-HIV related complications, such as chronic kidney disease. The objective of our study was to investigate the effect of proteinuria and tenofovir (TDF)-containing ART regimens on the temporal evolution of estimated glomerular filtration rate (eGFR). Between April 2008 and October 2012, we enrolled 395 patients with a complete renal evaluation among patients from the ANRS C03 Aquitaine cohort, a prospective hospital-based cohort of HIV-1-infected patients under routine clinical management in southwestern France. eGFR was estimated at each patient follow-up visit. A linear mixed model was used to analyze eGFR dynamics, accounting for change in TDF by modeling eGFR trajectory according to treatment periods. At inclusion, 56.7% of patients were treated with TDF-containing ART regimens; prevalence of glomerular and tubular proteinuria was 7.9 and 10.8% respectively. A 1-year increase of cumulative exposure to TDF was significantly associated with a mean eGFR decrease of 1.27 mL/min/1.73 m2 (95% CI [-2.14 to -0.41]). Only a urine protein to creatinine ratio >100 mg/mmol and/or a urine albumin to creatinine ratio >70 mg/mmol were associated with eGFR trajectory (mean slope 6.18 mL/min/1.73 m2 per year; 95% CI [2.71 to 9.65]), whereas TDF use was not associated with such eGFR temporal evolution. Decline in kidney function is limited under routine clinical management with monitoring of renal function and interventions including decision to continue or discontinue TDF. © 2017 S. Karger AG, Basel.

Stakeholders' views on the routine use of n-of-1 trials to improve clinical care and to make resource allocation decisions for drug use.

PubMed

Nikles, Jane; Mitchell, Geoffrey K; Clavarino, Alexandra; Yelland, Michael J; Del Mar, Christopher B

2010-03-01

N-of-1 trials are empirical formal tests using a within-patient randomised, double-blind, cross-over comparison of drug and placebo (or another drug), which we adapted to study individual patients' responses as a clinical tool to guide clinical management. We administered semi-structured interviews to gauge stakeholder perspectives on the possibility of using routine n-of-1 trials for this purpose. Stakeholders included government and non-government health care sector, and patient, clinician and consumer, organisations. Stakeholders supported more widespread implementation of n-of-1 trials, in a targeted fashion, with some caveats. Barriers to their widespread implementation included constraints on doctors' time, doctors' acceptance, drug company acceptance, patient willingness, and cost. Strategies for overcoming barriers included conditional Pharmaceutical Benefits Scheme listing if cost-effective. There was little consensus on which model of n-of-1 trial implementation would be most effective. We discuss different approaches to addressing the several concerns raised to enable widespread introduction of n-of-1 trials into routine clinical practice as a decision tool.

A blood chemistry profile for lake trout

USGS Publications Warehouse

Edsall, Carol Cotant

1999-01-01

A blood chemistry profile for lake trout Salvelinus namaycush was developed by establishing baseline ranges for several clinical chemistry tests (glucose, total protein, amylase, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, creatine kinase, calcium, and magnesium). Measurements were made accurately and rapidly with a Kodak Ektachem DT60 Analyzer and the Ektachem DTSC Module. Blood serum was collected from both laboratory-reared lake trout (1978 and 1986 year-classes) and feral spawning trout from Lake Michigan and then analyzed in the laboratory. No clinically significant differences were found between samples analyzed fresh and those frozen for 1 or 6 weeks. The ranges in chemistry variables for feral lake trout were generally wider than those for laboratory-reared lake trout, and significant differences existed between male and female feral lake trout for several tests. Blood chemistry profiles also varied seasonally on fish sampled repeatedly.

“Towards building better linkages between aqueous phase chemistry and microphysics in CMAQ”

EPA Science Inventory

Currently, CMAQ’s aqueous phase chemistry routine (AQCHEM-base) assumes Henry’s Law equilibrium and employs a forward Euler method to solve a small set of oxidation equations, considering the additional processes of aitken scavenging and wet deposition in series and e...

Factors Associated with Routine Dental Attendance among Aboriginal Australians.

PubMed

Amarasena, Najith; Kapellas, Kostas; Skilton, Michael R; Maple-Brown, Louise J; Brown, Alex; Bartold, Mark; O'Dea, Kerin; Celermajer, David; Jamieson, Lisa M

2016-01-01

To determine factors associated with routine dental attendance in Aboriginal Australians. Data of 271 Aboriginal adults residing in Australia's Northern Territory were used. Routine dental attendance was defined as last visiting a dentist less than one year ago or visiting a dentist for a check-up. Both bivariate and multivariable analytical techniques were used. While 27% visited a dentist in the past year, 29% of these visited for a check-up. In bivariate analysis, being female, low psychological distress, and low clinical attachment loss (CAL) were associated with visiting a dentist within last year. Being aged younger than 39 years, male, no oral health impairment, being caries-free, low CAL, and low apolipoprotein B were associated with visiting for a check-up. Clinical attachment loss remained associated with visiting a dentist less than one year ago while being younger than 39 years and having no oral health impairment remained associated with usually visiting for a check-up in multivariable analysis. Younger age, no oral health impairment, and low CAL were associated with routine dental attendance among Indigenous Australians.

Factors Associated with Routine Dental Attendance among Aboriginal Australians.

PubMed

Amarasena, Najith; Kapellas, Kostas; Skilton, Michael R; Maple-Brown, Louise J; Brown, Alex; Bartold, Mark; O'Dea, Kerin; Celermajer, David; Jamieson, Lisa M

2016-02-01

To determine factors associated with routine dental attendance in Aboriginal Australians. Data of 271 Aboriginal adults residing in Australia's Northern Territory were used. Routine dental attendance was defined as last visiting a dentist less than one year ago or visiting a dentist for a check-up. Both bivariate and multivariable analytical techniques were used. While 27% visited a dentist in the past year, 29% of these visited for a check-up. In bivariate analysis, being female, low psychological distress, and low clinical attachment loss (CAL) were associated with visiting a dentist within last year. Being aged younger than 39 years, male, no oral health impairment, being caries-free, low CAL, and low apolipoprotein B were associated with visiting for a check-up. Clinical attachment loss remained associated with visiting a dentist less than one year ago while being younger than 39 years and having no oral health impairment remained associated with usually visiting for a check-up in multivariable analysis. Younger age, no oral health impairment, and low CAL were associated with routine dental attendance among Indigenous Australians.

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

PubMed Central

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

2014-01-01

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

Patients' perceptions of sharing in decisions: a systematic review of interventions to enhance shared decision making in routine clinical practice.

PubMed

Légaré, France; Turcotte, Stéphane; Stacey, Dawn; Ratté, Stéphane; Kryworuchko, Jennifer; Graham, Ian D

2012-01-01

Shared decision making is the process in which a healthcare choice is made jointly by the health professional and the patient. Little is known about what patients view as effective or ineffective strategies to implement shared decision making in routine clinical practice. This systematic review evaluates the effectiveness of interventions to improve health professionals' adoption of shared decision making in routine clinical practice, as seen by patients. We searched electronic databases (PubMed, the Cochrane Library, EMBASE, CINAHL, and PsycINFO) from their inception to mid-March 2009. We found additional material by reviewing the reference lists of the studies found in the databases; systematic reviews of studies on shared decision making; the proceedings of various editions of the International Shared Decision Making Conference; and the transcripts of the Society for Medical Decision Making's meetings. In our study selection, we included randomized controlled trials, controlled clinical trials, controlled before-and-after studies, and interrupted time series analyses in which patients evaluated interventions to improve health professionals' adoption of shared decision making. The interventions in question consisted of the distribution of printed educational material; educational meetings; audit and feedback; reminders; and patient-mediated initiatives (e.g. patient decision aids). Two reviewers independently screened the studies and extracted data. Statistical analyses considered categorical and continuous process measures. We computed the standardized effect size for each outcome at the 95% confidence interval. The primary outcome of interest was health professionals' adoption of shared decision making as reported by patients in a self-administered questionnaire. Of the 6764 search results, 21 studies reported 35 relevant comparisons. Overall, the quality of the studies ranged from 0% to 83%. Only three of the 21 studies reported a clinically significant effect

AutoClickChem: click chemistry in silico.

PubMed

Durrant, Jacob D; McCammon, J Andrew

2012-01-01

Academic researchers and many in industry often lack the financial resources available to scientists working in "big pharma." High costs include those associated with high-throughput screening and chemical synthesis. In order to address these challenges, many researchers have in part turned to alternate methodologies. Virtual screening, for example, often substitutes for high-throughput screening, and click chemistry ensures that chemical synthesis is fast, cheap, and comparatively easy. Though both in silico screening and click chemistry seek to make drug discovery more feasible, it is not yet routine to couple these two methodologies. We here present a novel computer algorithm, called AutoClickChem, capable of performing many click-chemistry reactions in silico. AutoClickChem can be used to produce large combinatorial libraries of compound models for use in virtual screens. As the compounds of these libraries are constructed according to the reactions of click chemistry, they can be easily synthesized for subsequent testing in biochemical assays. Additionally, in silico modeling of click-chemistry products may prove useful in rational drug design and drug optimization. AutoClickChem is based on the pymolecule toolbox, a framework that may facilitate the development of future python-based programs that require the manipulation of molecular models. Both the pymolecule toolbox and AutoClickChem are released under the GNU General Public License version 3 and are available for download from http://autoclickchem.ucsd.edu.

AutoClickChem: Click Chemistry in Silico

PubMed Central

Durrant, Jacob D.; McCammon, J. Andrew

2012-01-01

Academic researchers and many in industry often lack the financial resources available to scientists working in “big pharma.” High costs include those associated with high-throughput screening and chemical synthesis. In order to address these challenges, many researchers have in part turned to alternate methodologies. Virtual screening, for example, often substitutes for high-throughput screening, and click chemistry ensures that chemical synthesis is fast, cheap, and comparatively easy. Though both in silico screening and click chemistry seek to make drug discovery more feasible, it is not yet routine to couple these two methodologies. We here present a novel computer algorithm, called AutoClickChem, capable of performing many click-chemistry reactions in silico. AutoClickChem can be used to produce large combinatorial libraries of compound models for use in virtual screens. As the compounds of these libraries are constructed according to the reactions of click chemistry, they can be easily synthesized for subsequent testing in biochemical assays. Additionally, in silico modeling of click-chemistry products may prove useful in rational drug design and drug optimization. AutoClickChem is based on the pymolecule toolbox, a framework that may facilitate the development of future python-based programs that require the manipulation of molecular models. Both the pymolecule toolbox and AutoClickChem are released under the GNU General Public License version 3 and are available for download from http://autoclickchem.ucsd.edu. PMID:22438795

Feasibility and Acceptability of Implementing Indirect Calorimetry Into Routine Clinical Care of Patients With Spinal Cord Injury

PubMed Central

Mayr, Hannah; Atresh, Sridhar; Kemp, Irene; Simmons, Joshua; Vivanti, Angela; Hickman, Ingrid J.

2016-01-01

Background: In the absence of reliable predictive equations, indirect calorimetry (IC) remains the gold standard for assessing energy requirements after spinal cord injury (SCI), but it is typically confined to a research setting. The purpose of this study is to assess the feasibility and acceptability of implementing IC into routine clinical care in an Australian SCI rehabilitation facility. Methods: Bedside IC (canopy hood) was performed, and patients completed an IC acceptability questionnaire (open-ended; yes/no; 5-point Likert scale). Fasted resting energy expenditure (REE) steady-state criteria were applied to assess data quality, and adherence to a test ≥20 minutes was recorded. Staff were surveyed to assess impact of IC on usual care. Results: Of 35 eligible patients, 9 declined (7 reported claustrophobia). One patient could not be tested before discharge and 25 underwent IC (84% male, injury level C2-L2, AIS A-D). Anxiety prevented one patient from completing IC, while another failed to fast. The remaining 23 patients achieved a steady-state REE (≥5 consecutive minutes with ≤10% coefficient of variation for VO2 and VCO2). Test-retest (n = 5) showed <10% variation in REE. Patients deemed the procedure acceptable, with 88% reporting a willingness to repeat IC. Eighty percent of patients and 90% of staff agreed it was acceptable for IC to be integrated into usual care. Conclusion: This study found that IC is a feasible and acceptable addition to the routine clinical care of patients recovering from SCI and may serve to improve accuracy of nutrition interventions for this patient population. PMID:29339868

Nonoperative management of blunt renal trauma: Is routine early follow-up imaging necessary?

PubMed Central

Malcolm, John B; Derweesh, Ithaar H; Mehrazin, Reza; DiBlasio, Christopher J; Vance, David D; Joshi, Salil; Wake, Robert W; Gold, Robert

2008-01-01

Background There is no consensus on the role of routine follow-up imaging during nonoperative management of blunt renal trauma. We reviewed our experience with nonoperative management of blunt renal injuries in order to evaluate the utility of routine early follow-up imaging. Methods We reviewed all cases of blunt renal injury admitted for nonoperative management at our institution between 1/2002 and 1/2006. Data were compiled from chart review, and clinical outcomes were correlated with CT imaging results. Results 207 patients were identified (210 renal units). American Association for the Surgery of Trauma (AAST) grades I, II, III, IV, and V were assigned to 35 (16%), 66 (31%), 81 (39%), 26 (13%), and 2 (1%) renal units, respectively. 177 (84%) renal units underwent routine follow-up imaging 24–48 hours after admission. In three cases of grade IV renal injury, a ureteral stent was placed after serial imaging demonstrated persistent extravasation. In no other cases did follow-up imaging independently alter clinical management. There were no urologic complications among cases for which follow-up imaging was not obtained. Conclusion Routine follow-up imaging is unnecessary for blunt renal injuries of grades I-III. Grade IV renovascular injuries can be followed clinically without routine early follow-up imaging, but urine extravasation necessitates serial imaging to guide management decisions. The volume of grade V renal injuries in this study is not sufficient to support or contest the need for routine follow-up imaging. PMID:18768088

[Status of the clinical laboratory in the mandatory postgraduate medical training system. (1) Report from a laboratory technologist].

PubMed

Nishikawa, Yoko

2006-06-01

According to a new system for postgraduate clinical training, 33 medical trainees have been accepted for the past two years at Osaka General Medical Center. Before practicing clinical medicine in each division by a super-rotated table, orientation is scheduled for 5 days to master the basic systems indispensable to the hospital. In this orientation, training in laboratory medicine is performed for 7 hours (3.5 hours for 2 days). Trainees are divided into 4 groups and learn emergency tests of chemistry, hematology and urinalysis, blood transfusion, physiology and microbiology for 60 min each. Laboratory technologists instruct the trainees to gain the basic skills. The main contents are blood gas measuring in chemistry, sample preparation in hematology and urinalysis, taking each other's ECG, ordering blood products for transfusion, serologic study of infectious diseases, and Gram stain in microbiology. Although it is difficult to find time for routine analysis and instructing trainees in the clinical laboratory, it is a suitable opportunity for revision, also for laboratory technologists, and for communication to discuss clinical matters.

A new vestibulo-ocular reflex recording system designed for routine vestibular clinical use.

PubMed

Funabiki, K; Naito, Y; Matsuda, K; Honjo, I

1999-01-01

A new vestibulo-ocular reflex (VOR) recording system was developed, which consists of an infrared eye camera, a small velocity sensor and a frequency modulator. Using this system, the head velocity signal was frequency modulated and simultaneously recorded as a sound signal on the audio track of a Hi8 video recorder with eye images. This device enabled recording of the VOR response in routine vestibular clinical practice. The reliability and effectiveness of this system were estimated by recording and analysing the VOR response against manually controlled rotation in normal subjects (n = 22) and in patients with unilateral severe vestibular hypofunction (n = 11). VOR gain on clockwise rotation viewed from the top was defined as R gain, and counterclockwise rotation as L gain. Directional preponderance (DP%) was also calculated. VOR gain towards the diseased side was significantly lower than that towards the intact side, and also significantly lower than that of normal subjects. DP% of unilateral vestibular hypofunction cases was significantly larger than that of normal subjects. These findings indicate that this VOR recording system reliably detects severe unilateral vestibular hypofunction.

Subthalamic Nucleus Visualization on Routine Clinical Preoperative MRI Scans: A Retrospective Study of Clinical and Image Characteristics Predicting Its Visualization.

PubMed

Ranjan, Manish; Boutet, Alexandre; Xu, David S; Lozano, Christopher S; Kumar, Rajeev; Fasano, Alfonso; Kucharczyk, Walter; Lozano, Andres M

2018-05-30

The visualization of the subthalamic nucleus (STN) on magnetic resonance imaging (MRI) is variable. Studies of the contribution of patient-related factors and intrinsic brain volumetrics to STN visualization have not been reported previously. To assess the visualization of the STN during deep brain stimulation (DBS) surgery in a clinical setting. Eighty-two patients undergoing pre-operative MRI to plan for STN DBS for Parkinson disease were retrospectively studied. The visualization of the STN and its borders was assessed and scored by 3 independent observers using a 4-point ordinal scale (from 0 = not seen to 3 = excellent visualization). This measure was then correlated with the patients' clinical information and brain volumes. The mean STN visualization scores were 1.68 and 1.63 for the right and left STN, respectively, with a good interobserver reliability (intraclass correlation coefficient: 0.744). Older age and decreased white matter volume were negatively correlated with STN visualization (p < 0.05). STN visualization is only fair to good on routine MRI with good concordance of interindividual rating. Advancing age and decreased white matter are associated with poor visualization of the STN. Knowledge about factors contributing to poor visualization of the STN could alert a surgeon to modify the imaging strategy to optimize surgical targeting. © 2018 S. Karger AG, Basel.

Analytical Chemistry Laboratory. Progress report for FY 1996

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

Green, D.W.; Boparai, A.S.; Bowers, D.L.

The purpose of this report is to summarize the activities of the Analytical Chemistry Laboratory (ACL) at Argonne National Laboratory (ANL) for Fiscal Year (FY) 1996. This annual report is the thirteenth for the ACL. It describes effort on continuing and new projects and contributions of the ACL staff to various programs at ANL. The ACL operates in the ANL system as a full-cost-recovery service center, but has a mission that includes a complementary research and development component: The Analytical Chemistry Laboratory will provide high-quality, cost-effective chemical analysis and related technical support to solve research problems of our clients --more » Argonne National Laboratory, the Department of Energy, and others -- and will conduct world-class research and development in analytical chemistry and its applications. Because of the diversity of research and development work at ANL, the ACL handles a wide range of analytical chemistry problems. Some routine or standard analyses are done, but the ACL usually works with commercial laboratories if our clients require high-volume, production-type analyses. It is common for ANL programs to generate unique problems that require significant development of methods and adaption of techniques to obtain useful analytical data. Thus, much of the support work done by the ACL is very similar to our applied analytical chemistry research.« less

Prospective evaluation of the VITEK MS for the routine identification of bacteria and yeast in the clinical microbiology laboratory: assessment of accuracy of identification and turnaround time.

PubMed

Charnot-Katsikas, Angella; Tesic, Vera; Boonlayangoor, Sue; Bethel, Cindy; Frank, Karen M

2014-02-01

This study assessed the accuracy of bacterial and yeast identification using the VITEK MS, and the time to reporting of isolates before and after its implementation in routine clinical practice. Three hundred and sixty-two isolates of bacteria and yeast, consisting of a variety of clinical isolates and American Type Culture Collection strains, were tested. Results were compared with reference identifications from the VITEK 2 system and with 16S rRNA sequence analysis. The VITEK MS provided an acceptable identification to species level for 283 (78 %) isolates. Considering organisms for which genus-level identification is acceptable for routine clinical care, 315 isolates (87 %) had an acceptable identification. Six isolates (2 %) were identified incorrectly, five of which were Shigella species. Finally, the time for reporting the identifications was decreased significantly after implementation of the VITEK MS for a total mean reduction in time of 10.52 h (P<0.0001). Overall, accuracy of the VITEK MS was comparable or superior to that from the VITEK 2. The findings were also comparable to other studies examining the accuracy of the VITEK MS, although differences exist, depending on the diversity of species represented as well as on the versions of the databases used. The VITEK MS can be incorporated effectively into routine use in a clinical microbiology laboratory and future expansion of the database should provide improved accuracy for the identification of micro-organisms.

Clinical use of an epinephrine-reduced (1/400,000) articaine solution in short-time dental routine treatments--a multicenter study.

PubMed

Daubländer, Monika; Kämmerer, Peer W; Willershausen, Brita; Leckel, Michael; Lauer, Hans-Christoph; Buff, Siegmar; Rösl, Benita

2012-08-01

The addition of epinephrine in dental local anaesthesia results in a longer and deeper anaesthesia under almost ischemic conditions. For short-time dental treatments, epinephrine-reduced anaesthetics may offer shorter and more individual anaesthesia with reduced potential side effects. The aim of this study was a clinical evaluation of anaesthetic potency and adverse effects of an epinephrine-reduced articaine formulation in dental patients undergoing short-time routine treatment. In a prospective clinical, not interventional, study between January 2008 and February 2009, 908 patients undergoing short-time dental treatment in five medical centers were anaesthetized with 4% articaine 1:400,000 epinephrine (Ubistesin, 3M/ESPE, Seefeld, Germany). Efficacy and safety in clinical use were evaluated. A follow-up after 1 day was conducted by telephone survey. A mean amount of 1.3-ml anaesthetic solution was needed to achieve a complete or sufficient anaesthesia in 97% (n = 876) of cases. A second injection had to be done in 3.7% (n = 34) before and in 11.9% (n = 108) during treatment. Here, the second injection had to be applied after a mean of 48.6 min. The mean duration of soft tissue anaesthesia after infiltration was 146.6 min, after nerve block 187.7 min. The painful treatment took a mean of 50.2 min and the total treatment time summed up to 68.8 min. In 1.7% cases (n = 15), unwanted side effects were observed. The results indicate that a lower concentration of epinephrine in combination with the 4% articaine solution leads to a high success rate of efficacy. The clinical use of a 4% articaine 1:400,000 epinephrine solution can be stated as safe and effective in short dental routine treatments. Reconsiderations concerning limitations of indication or additional contraindications are not necessary.

Hematology and Clinical Chemistry Measures During and After Pregnancy and Age- and Sex-Specific Reference Intervals in African Green Monkeys (Chlorocebus aethiops sabaeus).

PubMed

Chichester, Lee; Gee, Melaney K; Jorgensen, Matthew J; Kaplan, Jay R

2015-07-01

Clinical decisions and experimental analyses often involve the assessment of hematology and clinical chemistry. Using clinical pathology to assess the health status of NHP in breeding colonies or data from studies than involve pregnancy can often be complicated by pregnancy status. This study had 2 objectives regarding the hematology and clinical chemistry of African green monkeys (AGM, Chlorocebus aethiops sabaeus): 1) to compare pregnant or recently postpartum animals with nonpregnant, nonlactating animals and 2) to create age- and sex-specific reference intervals. Subjects in this study were 491 AGM from the Vervet Research Colony of the Wake Forest University Primate Center. Results indicated that changes in BUN, serum total protein, albumin, ALP, GGT, calcium, phosphorus, sodium, potassium, cholesterol, total CO2, globulins, lipase, amylase, WBC, neutrophils, lymphocytes, platelets, RBC, Hgb, and Hct occur during pregnancy and the postpartum period. Age- and sex-specific reference intervals consistent with guidelines from the American Society for Veterinary Clinical Pathology were established and further expand the understanding of how to define health in AGM on the basis of clinical pathology. The combination of understanding the changes that occur in pregnancy and postpartum and expansive reference intervals will help guide clinical and experimental decisions.

How does routinely delivered cognitive-behavioural therapy for gambling disorder compare to "gold standard" clinical trial?

PubMed

Smith, David P; Fairweather-Schmidt, A Kate; Harvey, Peter W; Battersby, Malcolm W

2018-03-01

Currently, it is unknown whether treatment outcomes derived from randomized controlled trials (RCTs) of cognitive-behavioural therapy (CBT) for problem gamblers still hold when applied to patients seen in routine practice. Thus, data from an RCT of cognitive therapy versus exposure therapy for problem gambling versus patients of a gambling help service were compared. Assessments of problem gambling severity, psychosocial impairment, and alcohol use were undertaken at baseline and post-treatment and evaluated within a counterfactual framework. Findings showed that the contrast between routine CBT for pokies and horse betting had a significant effect, indicative of a 62% lower gambling urge score if routine CBT recipients had all been horse/track betters opposed to gambling with "pokies." However, the majority of contrasts indicated therapeutic outcomes achieved in routine CBT treatments were of equivalent robustness relative to RCT conditions. The present findings infer routine practice treatment outcomes are as efficacious as those generated in RCT contexts. Copyright © 2017 John Wiley & Sons, Ltd.

SU-E-T-23: A Developing Australian Network for Datamining and Modelling Routine Radiotherapy Clinical Data and Radiomics Information for Rapid Learning and Clinical Decision Support

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

Thwaites, D; Holloway, L; Bailey, M

2015-06-15

Purpose: Large amounts of routine radiotherapy (RT) data are available, which can potentially add clinical evidence to support better decisions. A developing collaborative Australian network, with a leading European partner, aims to validate, implement and extend European predictive models (PMs) for Australian practice and assess their impact on future patient decisions. Wider objectives include: developing multi-institutional rapid learning, using distributed learning approaches; and assessing and incorporating radiomics information into PMs. Methods: Two initial standalone pilots were conducted; one on NSCLC, the other on larynx, patient datasets in two different centres. Open-source rapid learning systems were installed, for data extraction andmore » mining to collect relevant clinical parameters from the centres’ databases. The European DSSs were learned (“training cohort”) and validated against local data sets (“clinical cohort”). Further NSCLC studies are underway in three more centres to pilot a wider distributed learning network. Initial radiomics work is underway. Results: For the NSCLC pilot, 159/419 patient datasets were identified meeting the PM criteria, and hence eligible for inclusion in the curative clinical cohort (for the larynx pilot, 109/125). Some missing data were imputed using Bayesian methods. For both, the European PMs successfully predicted prognosis groups, but with some differences in practice reflected. For example, the PM-predicted good prognosis NSCLC group was differentiated from a combined medium/poor prognosis group (2YOS 69% vs. 27%, p<0.001). Stage was less discriminatory in identifying prognostic groups. In the good prognosis group two-year overall survival was 65% in curatively and 18% in palliatively treated patients. Conclusion: The technical infrastructure and basic European PMs support prognosis prediction for these Australian patient groups, showing promise for supporting future personalized treatment decisions

Intensive cognitive therapy for post-traumatic stress disorder in routine clinical practice: A matched comparison audit.

PubMed

Murray, Hannah; El-Leithy, Sharif; Billings, Jo

2017-11-01

Intensive cognitive therapy for post-traumatic stress disorder (PTSD) has been shown to be as effective as weekly treatment in controlled trials. In this study, outcome data comparing standard and intensive treatments delivered in routine clinical practice were analysed. A consecutive case series of intensive treatment cases were compared to matched control cases who had completed weekly treatment. Both groups showed significant improvements on PTSD and depression measures. The intensive group showed larger PTSD symptomatic improvement. There were differences between the groups in age and time since trauma, suggesting selection biases in who is offered, and/or who chooses intensive treatment. For some individuals, an intensive format may be more effective than weekly treatment. © 2017 The British Psychological Society.

Using routinely recorded data in the UK to assess outcomes in a randomised controlled trial: The Trials of Access.

PubMed

Powell, G A; Bonnett, L J; Tudur-Smith, C; Hughes, D A; Williamson, P R; Marson, A G

2017-08-23

In the UK, routinely recorded data may benefit prospective studies including randomised controlled trials (RCTs). In an on-going study, we aim to assess the feasibility of access and agreement of routinely recorded clinical and non-clinical data compared to data collected during a RCT using standard prospective methods. This paper will summarise available UK routinely recorded data sources and discuss our experience with the feasibility of accessing routinely recorded data for participants of a RCT before finally proposing recommendations for improving the access and implementation of routinely recorded data in RCTs. Setting: the case study RCT is the Standard and New Antiepileptic Drugs II (SANAD II) trial, a pragmatic, UK, multicentre, phase IV RCT assessing the clinical and cost-effectiveness of antiepileptic drug treatments for newly diagnosed epilepsy. 98 participants have provided written consent to permit the request of routinely recorded data. Study procedures: routinely recorded clinical and non-clinical data were identified and data requested through formal applications from available data holders for the duration that participants have been recruited into SANAD II. The feasibility of accessing routinely recorded data during a RCT is assessed and recommendations for improving access proposed. Secondary-care clinical and socioeconomic data is recorded on a national basis and can be accessed, although there are limitations in the application process. Primary-care data are recorded by a number of organisations on a de-identified basis but access for specific individuals has not been feasible. Access to data recorded by non-clinical sources, including The Department for Work and Pensions and The Driving and Vehicle Licensing Agency, was not successful. Recommendations discussed include further research to assess the attributes of routinely recorded data, an assessment of public perceptions and the development of strategies to collaboratively improve access to

Art, auto-mechanics, and supramolecular chemistry. A merging of hobbies and career

PubMed Central

2016-01-01

Summary While the strict definition of supramolecular chemistry is “chemistry beyond the molecule”, meaning having a focus on non-covalent interactions, the field is primarily associated with the creation of synthetic receptors and self-assembly. For synthetic ease, the receptors and assemblies routinely possess a high degree of symmetry, which lends them an aspect of aesthetic beauty. Pictures of electron orbitals similarly can be seen as akin to works of art. This similarity was an early draw for me to the fields of supramolecular chemistry and molecular orbital theory, because I grew up in a household filled with art. In addition to art, my childhood was filled with repairing and constructing mechanical entities, such as internal combustion motors, where many components work together to achieve a function. Analogously, the field of supramolecular chemistry creates systems of high complexity that achieve functions or perform tasks. Therefore, in retrospect a career in supramolecular chemistry appears to be simply an extension of childhood hobbies involving art and auto-mechanics. PMID:26977197

The young adult Strengths and Difficulties Questionnaire (SDQ) in routine clinical practice.

PubMed

Brann, Peter; Lethbridge, Melissa J; Mildred, Helen

2018-06-01

Expansion of the youth mental health sector has exposed a need for an outcome measure for young adults accessing services. The Strengths and Difficulties Questionnaire (SDQ) is a widely used consumer and carer outcome measure for children and adolescents. The aim of this study was to evaluate the psychometric properties of a young adult SDQ. The young adult SDQ was introduced for routine clinical practice at Eastern Health Child and Youth Mental Health Service (EH-CYMHS), complementing the well-established adolescent and child versions. Data for adolescents (aged 12-17) and young adults (aged 18-25) where both self-report and parent SDQs had been completed at entry point to the service were extracted from a two-year period. Overall, paired cases involved 532 adolescents and 125 young adults. Across both self-report and parent SDQs, a similar pattern of results was found between adolescents and young adults on mean scores, inter-scale correlations, internal consistency, and inter-rater agreement. The findings of the current study support the use of the young adult SDQ in public mental health as an instrument whose psychometric properties, to date, appear consistent with those of the adolescent version. Further investigation is warranted. Copyright © 2018 Elsevier B.V. All rights reserved.

An approach to quality and performance control in a computer-assisted clinical chemistry laboratory.

PubMed Central

Undrill, P E; Frazer, S C

1979-01-01

A locally developed, computer-based clinical chemistry laboratory system has been in operation since 1970. This utilises a Digital Equipment Co Ltd PDP 12 and an interconnected PDP 8/F computer. Details are presented of the performance and quality control techniques incorporated into the system. Laboratory performance is assessed through analysis of results from fixed-level control sera as well as from cumulative sum methods. At a simple level the presentation may be considered purely indicative, while at a more sophisticated level statistical concepts have been introduced to aid the laboratory controller in decision-making processes. PMID:438340

Visual acuity and central retinal thickness: fulfilment of retreatment criteria for recurrent neovascular AMD in routine clinical care.

PubMed

Reznicek, Lukas; Muhr, Johanna; Ulbig, Michael; Kampik, Anselm; Mayer, Wolfgang J; Haritoglou, Christos; Neubauer, Aljoscha; Wolf, Armin

2014-10-01

To evaluate the fulfillment of retreatment criteria in recurrent neovascular age-related macular degeneration (nAMD) for a pro-re-nata treatment regime with ranibizumab in routine clinical care. Data from patients with treatment-naive nAMD were analysed retrospectively. As an 'upload', all patients had received three-monthly intravitreal ranibizumab injections in a university eye hospital and were then seen by ophthalmologists in private practice who referred them back in case of recurrence. Recurrence was defined as a decrease of visual acuity (VA) of one line or more (functional retreatment criteria), a central retinal thickness (CRT) increase of at least 100 µm upon Optical Coherence Tomography (OCT) examination (morphological retreatment criteria) or a new macular haemorrhage (clinical retreatment criteria). We included 92 patients (36 men and 56 women). The mean VA before retreatment of a recurrence was -0.63 ± 0.33 logMAR and improved significantly (p<0.001) by 0.10 ± 0.16 logMAR to -0.53 ± 0.28 logMAR thereafter. Mean CRT before retreatment was 278.07 ± 87.56 µm and decreased significantly (p<0.001) by 71.22 ± 106.93 to 206.85 ± 60.30 µm. Evaluation of the fulfillment of retreatment criteria revealed functional retreatment criteria in 82.6% of patients. However, upon re-evaluation of VA using Early Treatment Diabetic Retinopathy Study (ETDRS) charts in the treatment centre, mean decrease of VA was 10 letters as compared with the end of upload therapy. All patients presented an increased CRT when treated for recurrence of nAMD (mean increase 69.47 µm), but the morphological retreatment criteria (CRT increase of 100 µm or more) were fulfilled in only 44.4% of patients upon Spectral Domain OCT (SD-OCT) evaluation in the treatment centre. In a routine clinical care, evaluation of VA using ETDRS charts seems to be more sensitive than Snellen VA testing. Quantitative OCT-based retreatment criteria (eg, increase of CRT of 100 µm or more) appear to be

[Use of PubMed to improve evidence-based medicine in routine urological practice].

PubMed

Rink, M; Kluth, L A; Shariat, S F; Chun, F K; Fisch, M; Dahm, P

2013-03-01

Applying evidence-based medicine in daily clinical practice is the basis of patient-centered medicine and knowledge of accurate literature acquisition skills is necessary for informed clinical decision-making. PubMed is an easy accessible, free bibliographic database comprising over 21 million citations from the medical field, life-science journals and online books. The article summarizes the effective use of PubMed in routine urological clinical practice based on a common case scenario. This article explains the simple use of PubMed to obtain the best search results with the highest evidence. Accurate knowledge about the use of PubMed in routine clinical practice can improve evidence-based medicine and also patient treatment.

National survey on intra-laboratory turnaround time for some most common routine and stat laboratory analyses in 479 laboratories in China.

PubMed

Fei, Yang; Zeng, Rong; Wang, Wei; He, Falin; Zhong, Kun; Wang, Zhiguo

2015-01-01

To investigate the state of the art of intra-laboratory turnaround time (intra-TAT), provide suggestions and find out whether laboratories accredited by International Organization for Standardization (ISO) 15189 or College of American Pathologists (CAP) will show better performance on intra-TAT than non-accredited ones. 479 Chinese clinical laboratories participating in the external quality assessment programs of chemistry, blood gas, and haematology tests organized by the National Centre for Clinical Laboratories in China were included in our study. General information and the median of intra-TAT of routine and stat tests in last one week were asked in the questionnaires. The response rate of clinical biochemistry, blood gas, and haematology testing were 36% (479/1307), 38% (228/598), and 36% (449/1250), respectively. More than 50% of laboratories indicated that they had set up intra-TAT median goals and almost 60% of laboratories declared they had monitored intra-TAT generally for every analyte they performed. Among all analytes we investigated, the intra-TAT of haematology analytes was shorter than biochemistry while the intra-TAT of blood gas analytes was the shortest. There were significant differences between median intra-TAT on different days of the week for routine tests. However, there were no significant differences in median intra-TAT reported by accredited laboratories and non-accredited laboratories. Many laboratories in China are aware of intra-TAT control and are making effort to reach the target. There is still space for improvement. Accredited laboratories have better status on intra-TAT monitoring and target setting than the non-accredited, but there are no significant differences in median intra-TAT reported by them.

National survey on intra-laboratory turnaround time for some most common routine and stat laboratory analyses in 479 laboratories in China

PubMed Central

Fei, Yang; Zeng, Rong; Wang, Wei; He, Falin; Zhong, Kun

2015-01-01

Introduction To investigate the state of the art of intra-laboratory turnaround time (intra-TAT), provide suggestions and find out whether laboratories accredited by International Organization for Standardization (ISO) 15189 or College of American Pathologists (CAP) will show better performance on intra-TAT than non-accredited ones. Materials and methods 479 Chinese clinical laboratories participating in the external quality assessment programs of chemistry, blood gas, and haematology tests organized by the National Centre for Clinical Laboratories in China were included in our study. General information and the median of intra-TAT of routine and stat tests in last one week were asked in the questionnaires. Results The response rate of clinical biochemistry, blood gas, and haematology testing were 36% (479 / 1307), 38% (228 / 598), and 36% (449 / 1250), respectively. More than 50% of laboratories indicated that they had set up intra-TAT median goals and almost 60% of laboratories declared they had monitored intra-TAT generally for every analyte they performed. Among all analytes we investigated, the intra-TAT of haematology analytes was shorter than biochemistry while the intra-TAT of blood gas analytes was the shortest. There were significant differences between median intra-TAT on different days of the week for routine tests. However, there were no significant differences in median intra-TAT reported by accredited laboratories and non-accredited laboratories. Conclusions Many laboratories in China are aware of intra-TAT control and are making effort to reach the target. There is still space for improvement. Accredited laboratories have better status on intra-TAT monitoring and target setting than the non-accredited, but there are no significant differences in median intra-TAT reported by them. PMID:26110033

“There Are Too Many, but Never Enough": Qualitative Case Study Investigating Routine Coding of Clinical Information in Depression

PubMed Central

Cresswell, Kathrin; Morrison, Zoe; Sheikh, Aziz; Kalra, Dipak

2012-01-01

Background We sought to understand how clinical information relating to the management of depression is routinely coded in different clinical settings and the perspectives of and implications for different stakeholders with a view to understanding how these may be aligned. Materials and Methods Qualitative investigation exploring the views of a purposefully selected range of healthcare professionals, managers, and clinical coders spanning primary and secondary care. Results Our dataset comprised 28 semi-structured interviews, a focus group, documents relating to clinical coding standards and participant observation of clinical coding activities. We identified a range of approaches to coding clinical information including templates and order entry systems. The challenges inherent in clearly establishing a diagnosis, identifying appropriate clinical codes and possible implications of diagnoses for patients were particularly prominent in primary care. Although a range of managerial and research benefits were identified, there were no direct benefits from coded clinical data for patients or professionals. Secondary care staff emphasized the role of clinical coders in ensuring data quality, which was at odds with the policy drive to increase real-time clinical coding. Conclusions There was overall no evidence of clear-cut direct patient care benefits to inform immediate care decisions, even in primary care where data on patients with depression were more extensively coded. A number of important secondary uses were recognized by healthcare staff, but the coding of clinical data to serve these ends was often poorly aligned with clinical practice and patient-centered considerations. The current international drive to encourage clinical coding by healthcare professionals during the clinical encounter may need to be critically examined. PMID:22937106

Attempts to control clothes-borne infection in a burn unit, 2. Clothing routines in clinical use and the epidemiology of cross-colonization.

PubMed Central

Ransjö, U.

1979-01-01

Previous investigations have shown that cross-contamination in a burn unit is mainly clothes-borne. New barrier garments have been designed and tried experimentally. The aim of the present study was to investigate the effects of different clothing routines on cross-contamination. In a long-term study, the rates and routes of colonizations with Staphylococcus aureus, Streptococcus groups A, B, C, F, and G and Pseudomonas aeruginosa were examined. The exogenous colonization rates were, with S. aureus 77%, with Streptococcus species 52% and with Ps. aeruginosa 32%. The colonization rate with Ps. aeruginosa was higher in patients with larger burns. Patients dispersed Streptococcus and Ps. aeruginosa as well as S. aureus into the air of their rooms in considerable amounts, but dispersers were not more important as sources of cross-colonization than non-dispersers. In comparison of clothing routines, there was no difference in overall colonization rates. The newly designed barrier garment that was made from apparently particle-tight material did not reduce the transfer of bacteria from patient to patient. A less rigid routine than that previously used did not increase the risk of cross-contamination. A thorough change of barrier dress after close contact nursing delayed the first exogenous S. aureus colonization from day 6 to day 14 after admission. This routine might be recommended for clinical use. Otherwise, methods must be developed for adequate selection of materials intended for barrier garments. Images Plate 1 PMID:109498

Brand-to-generic levetiracetam switch in patients with epilepsy in a routine clinical setting.

PubMed

Markoula, Sofia; Chatzistefanidis, Dimitrios; Gatzonis, Stylianos; Siatouni, Anna; Siarava, Eleftheria; Verentzioti, Anastasia; Kyritsis, Athanassios P; Patsalos, Philip N

2017-05-01

The therapeutic equivalence of generic and brand antiepileptic drugs, based on studies performed on healthy volunteers, has been questioned. We compare, in a routine clinical setting, brand versus generic levetiracetam (LEV) bioequivalence in patients with epilepsy and also the clinical efficacy and tolerability of the substitution. A prospective, open-label, non-randomized, steady-state, multiple-dose, bioequivalence study was conducted in 12 patients with epilepsy (5 females), with a mean age of 38.4±16.2 years. Patients treated with the brand LEV (Keppra; UCB Pharma) were closely followed for a four-week period and subsequently switched to a generic LEV (Pharmaten) and followed for another four-week period. Blood samples were collected at the end of each 4-week period, during a dose interval for each formulation, for LEV concentration measurements by liquid chromatography mass spectrometry. Steady-state area under the curve (AUC) and peak plasma concentration (Cmax) data were subjected to conventional average bioequivalence analysis. Secondary clinical outcomes, including seizure frequency and adverse events, were recorded. Patients had epilepsy for a mean period of 14.1±10.6years and the mean daily LEV dose was 2583.3±763.7mg. The mean AUC±SD and Cmax±SD was 288.4±86.3(mg/L)h and 37.8±10.4mg/L respectively for brand LEV and 319.2±104.7(mg/L)h and 41.6±12.3mg/L respectively for the generic LEV. Statistic analysis showed no statistical significant difference in bioequivalence. Also, no change in seizures frequency and/or adverse events was recorded. In our clinical setting, generic LEV was determined to be bioequivalent to brand LEV. Furthermore, seizures frequency or/and adverse events were not affected upon switching from brand to generic LEV. Copyright © 2017 British Epilepsy Association. Published by Elsevier Ltd. All rights reserved.

A simple method for plasma total vitamin C analysis suitable for routine clinical laboratory use.

PubMed

Robitaille, Line; Hoffer, L John

2016-04-21

In-hospital hypovitaminosis C is highly prevalent but almost completely unrecognized. Medical awareness of this potentially important disorder is hindered by the inability of most hospital laboratories to determine plasma vitamin C concentrations. The availability of a simple, reliable method for analyzing plasma vitamin C could increase opportunities for routine plasma vitamin C analysis in clinical medicine. Plasma vitamin C can be analyzed by high performance liquid chromatography (HPLC) with electrochemical (EC) or ultraviolet (UV) light detection. We modified existing UV-HPLC methods for plasma total vitamin C analysis (the sum of ascorbic and dehydroascorbic acid) to develop a simple, constant-low-pH sample reduction procedure followed by isocratic reverse-phase HPLC separation using a purely aqueous low-pH non-buffered mobile phase. Although EC-HPLC is widely recommended over UV-HPLC for plasma total vitamin C analysis, the two methods have never been directly compared. We formally compared the simplified UV-HPLC method with EC-HPLC in 80 consecutive clinical samples. The simplified UV-HPLC method was less expensive, easier to set up, required fewer reagents and no pH adjustments, and demonstrated greater sample stability than many existing methods for plasma vitamin C analysis. When compared with the gold-standard EC-HPLC method in 80 consecutive clinical samples exhibiting a wide range of plasma vitamin C concentrations, it performed equivalently. The easy set up, simplicity and sensitivity of the plasma vitamin C analysis method described here could make it practical in a normally equipped hospital laboratory. Unlike any prior UV-HPLC method for plasma total vitamin C analysis, it was rigorously compared with the gold-standard EC-HPLC method and performed equivalently. Adoption of this method could increase the availability of plasma vitamin C analysis in clinical medicine.

Performance Evaluation of an Automated ELISA System for Alzheimer's Disease Detection in Clinical Routine.

PubMed

Chiasserini, Davide; Biscetti, Leonardo; Farotti, Lucia; Eusebi, Paolo; Salvadori, Nicola; Lisetti, Viviana; Baschieri, Francesca; Chipi, Elena; Frattini, Giulia; Stoops, Erik; Vanderstichele, Hugo; Calabresi, Paolo; Parnetti, Lucilla

2016-07-22

The variability of Alzheimer's disease (AD) cerebrospinal fluid (CSF) biomarkers undermines their full-fledged introduction into routine diagnostics and clinical trials. Automation may help to increase precision and decrease operator errors, eventually improving the diagnostic performance. Here we evaluated three new CSF immunoassays, EUROIMMUNtrademark amyloid-β 1-40 (Aβ1-40), amyloid-β 1-42 (Aβ1-42), and total tau (t-tau), in combination with automated analysis of the samples. The CSF biomarkers were measured in a cohort consisting of AD patients (n = 28), mild cognitive impairment (MCI, n = 77), and neurological controls (OND, n = 35). MCI patients were evaluated yearly and cognitive functions were assessed by Mini-Mental State Examination. The patients clinically diagnosed with AD and MCI were classified according to the CSF biomarkers profile following NIA-AA criteria and the Erlangen score. Technical evaluation of the immunoassays was performed together with the calculation of their diagnostic performance. Furthermore, the results for EUROIMMUN Aβ1-42 and t-tau were compared to standard immunoassay methods (INNOTESTtrademark). EUROIMMUN assays for Aβ1-42 and t-tau correlated with INNOTEST (r = 0.83, p < 0.001 for both) and allowed a similar interpretation of the CSF profiles. The Aβ1-42/Aβ1-40 ratio measured with EUROIMMUN was the best parameter for AD detection and improved the diagnostic accuracy of Aβ1-42 (area under the curve = 0.93). In MCI patients, the Aβ1-42/Aβ1-40 ratio was associated with cognitive decline and clinical progression to AD.The diagnostic performance of the EUROIMMUN assays with automation is comparable to other currently used methods. The variability of the method and the value of the Aβ1-42/Aβ1-40 ratio in AD diagnosis need to be validated in large multi-center studies.

A Competency-Based Clinical Chemistry Course for the Associate Degree Medical Laboratory Technician Graduate in a Medical Technology Baccalaureate Program.

ERIC Educational Resources Information Center

Buccelli, Pamela

Presented is a project that developed a competency-based clinical chemistry course for associate degree medical laboratory technicians (MLT) in a medical technology (MT) baccalaureate program. Content of the course was based upon competencies expected of medical technologists at career-entry as defined in the statements adopted in 1976 by the…

A clinical evaluation of placental growth factor in routine practice in high-risk women presenting with suspected pre-eclampsia and/or fetal growth restriction.

PubMed

Ormesher, L; Johnstone, E D; Shawkat, E; Dempsey, A; Chmiel, C; Ingram, E; Higgins, L E; Myers, J E

2018-03-13

To evaluate the use of plasma Placental Growth Factor (PlGF), recommended by the recent NICE guidance, in women with suspected pre-eclampsia (PE) and/or fetal growth restriction (FGR). Non-randomised prospective clinical evaluation study in high-risk antenatal clinics in a tertiary maternity unit. PlGF testing was performed in addition to routine clinical assessment in 260 women >20 weeks' gestation with chronic disease (hypertension, renal disease ± diabetes) with a change in maternal condition or in women with suspected FGR to determine the impact on clinical management. Results were revealed and standardised care pathways followed. Outcome of pregnancies with a low PlGF (<12 pg/ml and 13-100 pg/ml), impact on clinical service and the diagnostic accuracy of alternative PlGF cut-offs. 206/260 (79.2%) women had an adverse outcome (PE/birthweight < 10th centile/preterm birth). In our cohort, a low PlGF (<12 pg/ml) was associated with a shorter test-birth interval and universally (100% PPV) with an adverse pregnancy outcome, although 29/61 (47.5%) of women with PlGF < 12 pg/ml continued their pregnancy >14 days. The PlGF result altered clinical management (surveillance or timing of birth) in 196/260 (75.4%) cases. Alternative PlGF thresholds did not significantly improve diagnostic performance. Our evaluation confirms the value of PlGF as a diagnostic tool for placental dysfunction. However, low PlGF in isolation should not trigger iatrogenic delivery. Further research linking placental pathology, maternal disease and maternal PlGF levels is urgently needed before this test can be implemented in routine clinical practice. Copyright © 2018. Published by Elsevier B.V.

Laboratory-based clinical audit as a tool for continual improvement: an example from CSF chemistry turnaround time audit in a South-African teaching hospital.

PubMed

Imoh, Lucius C; Mutale, Mubanga; Parker, Christopher T; Erasmus, Rajiv T; Zemlin, Annalise E

2016-01-01

Timeliness of laboratory results is crucial to patient care and outcome. Monitoring turnaround times (TAT), especially for emergency tests, is important to measure the effectiveness and efficiency of laboratory services. Laboratory-based clinical audits reveal opportunities for improving quality. Our aim was to identify the most critical steps causing a high TAT for cerebrospinal fluid (CSF) chemistry analysis in our laboratory. A 6-month retrospective audit was performed. The duration of each operational phase across the laboratory work flow was examined. A process-mapping audit trail of 60 randomly selected requests with a high TAT was conducted and reasons for high TAT were tested for significance. A total of 1505 CSF chemistry requests were analysed. Transport of samples to the laboratory was primarily responsible for the high average TAT (median TAT = 170 minutes). Labelling accounted for most delays within the laboratory (median TAT = 71 minutes) with most delays occurring after regular work hours (P < 0.05). CSF chemistry requests without the appropriate number of CSF sample tubes were significantly associated with delays in movement of samples from the labelling area to the technologist's work station (caused by a preference for microbiological testing prior to CSF chemistry). A laboratory-based clinical audit identified sample transportation, work shift periods and use of inappropriate CSF sample tubes as drivers of high TAT for CSF chemistry in our laboratory. The results of this audit will be used to change pre-analytical practices in our laboratory with the aim of improving TAT and customer satisfaction.

Laboratory-based clinical audit as a tool for continual improvement: an example from CSF chemistry turnaround time audit in a South-African teaching hospital

PubMed Central

Imoh, Lucius C; Mutale, Mubanga; Parker, Christopher T; Erasmus, Rajiv T; Zemlin, Annalise E

2016-01-01

Introduction Timeliness of laboratory results is crucial to patient care and outcome. Monitoring turnaround times (TAT), especially for emergency tests, is important to measure the effectiveness and efficiency of laboratory services. Laboratory-based clinical audits reveal opportunities for improving quality. Our aim was to identify the most critical steps causing a high TAT for cerebrospinal fluid (CSF) chemistry analysis in our laboratory. Materials and methods A 6-month retrospective audit was performed. The duration of each operational phase across the laboratory work flow was examined. A process-mapping audit trail of 60 randomly selected requests with a high TAT was conducted and reasons for high TAT were tested for significance. Results A total of 1505 CSF chemistry requests were analysed. Transport of samples to the laboratory was primarily responsible for the high average TAT (median TAT = 170 minutes). Labelling accounted for most delays within the laboratory (median TAT = 71 minutes) with most delays occurring after regular work hours (P < 0.05). CSF chemistry requests without the appropriate number of CSF sample tubes were significantly associated with delays in movement of samples from the labelling area to the technologist’s work station (caused by a preference for microbiological testing prior to CSF chemistry). Conclusion A laboratory-based clinical audit identified sample transportation, work shift periods and use of inappropriate CSF sample tubes as drivers of high TAT for CSF chemistry in our laboratory. The results of this audit will be used to change pre-analytical practices in our laboratory with the aim of improving TAT and customer satisfaction. PMID:27346964

Utility of repeat testing of critical values: a Q-probes analysis of 86 clinical laboratories.

PubMed

Lehman, Christopher M; Howanitz, Peter J; Souers, Rhona; Karcher, Donald S

2014-06-01

A common laboratory practice is to repeat critical values before reporting the test results to the clinical care provider. This may be an unnecessary step that delays the reporting of critical test results without adding value to the accuracy of the test result. To determine the proportions of repeated chemistry and hematology critical values that differ significantly from the original value as defined by the participating laboratory, to determine the threshold differences defined by the laboratory as clinically significant, and to determine the additional time required to analyze the repeat test. Participants prospectively reviewed critical test results for 4 laboratory tests: glucose, potassium, white blood cell count, and platelet count. Participants reported the following information: initial and repeated test result; time initial and repeat results were first known to laboratory staff; critical result notification time; if the repeat result was still a critical result; if the repeat result was significantly different from the initial result, as judged by the laboratory professional or policy; significant difference threshold, as defined by the laboratory; the make and model of the instrument used for primary and repeat testing. Routine, repeat analysis of critical values is a common practice. Most laboratories did not formally define a significant difference between repeat results. Repeated results were rarely considered significantly different. Median repeated times were at least 17 to 21 minutes for 10% of laboratories. Twenty percent of laboratories reported at least 1 incident in the last calendar year of delayed result reporting that clinicians indicated had adversely affected patient care. Routine repeat analysis of automated chemistry and hematology critical values is unlikely to be clinically useful and may adversely affect patient care.

The use and impact of cancer medicines in routine clinical care: methods and observations in a cohort of elderly Australians

PubMed Central

Pearson, Sallie-Anne; Schaffer, Andrea

2014-01-01

Introduction After medicines have been subsidised in Australia we know little about their use in routine clinical practice, impact on resource utilisation, effectiveness or safety. Routinely collected administrative health data are available to address these issues in large population-based pharmacoepidemiological studies. By bringing together cross-jurisdictional data collections that link drug exposure to real-world outcomes, this research programme aims to evaluate the use and impact of cancer medicines in a subset of elderly Australians in the real-world clinical setting. Methods and analysis This ongoing research programme involves a series of retrospective cohort studies of Australian Government Department of Veterans’ Affairs (DVA) clients. The study population includes 104 635 veterans who reside in New South Wales, Australia, and were aged 65 years and over as of 1 July 2004. We will investigate trends in cancer medicines use according to cancer type and other sociodemographic characteristics as well as predictors of the initiation of cancer medicines and other treatment modalities, survival and adverse outcomes among patients with cancer. The programme is underpinned by the linkage of eight health administrative databases under the custodianship of the DVA and the New South Wales Ministry of Health, including cancer notifications, medicines dispensing data, hospitalisation data and health services data. The cancer notifications database is available from 1994 with all other databases available from 2005 onwards. Ethics and dissemination Ethics approval has been granted by the DVA and New South Wales Population and Health Service Research Ethics Committees. Results Results will be reported in peer-reviewed publications, conference presentations and policy forums. The programme has high translational potential, providing invaluable evidence about cancer medicines in an elderly population who are under-represented in clinical trials. PMID:24793244

Psychometric characteristics of Clinical Reasoning Problems (CRPs) and its correlation with routine multiple choice question (MCQ) in Cardiology department

PubMed Central

DERAKHSHANDEH, ZAHRA; AMINI, MITRA; KOJURI, JAVAD; DEHBOZORGIAN, MARZIYEH

2018-01-01

Introduction: Clinical reasoning is one of the most important skills in the process of training a medical student to become an efficient physician. Assessment of the reasoning skills in a medical school program is important to direct students’ learning. One of the tests for measuring the clinical reasoning ability is Clinical Reasoning Problems (CRPs). The major aim of this study is to measure psychometric qualities of CRPs and define correlation between this test and routine MCQ in cardiology department of Shiraz medical school. Methods: This study was a descriptive study conducted on total cardiology residents of Shiraz Medical School. The study population consists of 40 residents in 2014. The routine CRPs and the MCQ tests was designed based on similar objectives and were carried out simultaneously. Reliability, item difficulty, item discrimination, and correlation between each item and the total score of CRPs were all measured by Excel and SPSS software for checking psycometeric CRPs test. Furthermore, we calculated the correlation between CRPs test and MCQ test. The mean differences of CRPs test score between residents’ academic year [second, third and fourth year] were also evaluated by Analysis of variances test (One Way ANOVA) using SPSS software (version 20)(α=0.05). Results: The mean and standard deviation of score in CRPs was 10.19 ±3.39 out of 20; in MCQ, it was 13.15±3.81 out of 20. Item difficulty was in the range of 0.27-0.72; item discrimination was 0.30-0.75 with question No.3 being the exception (that was 0.24). The correlation between each item and the total score of CRP was 0.26-0.87; the correlation between CRPs test and MCQ test was 0.68 (p<0.001). The reliability of the CRPs was 0.72 as calculated by using Cronbach's alpha. The mean score of CRPs was different among residents based on their academic year and this difference was statistically significant (p<0.001). Conclusion: The results of this present investigation revealed that CRPs

Psychometric characteristics of Clinical Reasoning Problems (CRPs) and its correlation with routine multiple choice question (MCQ) in Cardiology department.

PubMed

Derakhshandeh, Zahra; Amini, Mitra; Kojuri, Javad; Dehbozorgian, Marziyeh

2018-01-01

Clinical reasoning is one of the most important skills in the process of training a medical student to become an efficient physician. Assessment of the reasoning skills in a medical school program is important to direct students' learning. One of the tests for measuring the clinical reasoning ability is Clinical Reasoning Problems (CRPs). The major aim of this study is to measure psychometric qualities of CRPs and define correlation between this test and routine MCQ in cardiology department of Shiraz medical school. This study was a descriptive study conducted on total cardiology residents of Shiraz Medical School. The study population consists of 40 residents in 2014. The routine CRPs and the MCQ tests was designed based on similar objectives and were carried out simultaneously. Reliability, item difficulty, item discrimination, and correlation between each item and the total score of CRPs were all measured by Excel and SPSS software for checking psycometeric CRPs test. Furthermore, we calculated the correlation between CRPs test and MCQ test. The mean differences of CRPs test score between residents' academic year [second, third and fourth year] were also evaluated by Analysis of variances test (One Way ANOVA) using SPSS software (version 20)(α=0.05). The mean and standard deviation of score in CRPs was 10.19 ±3.39 out of 20; in MCQ, it was 13.15±3.81 out of 20. Item difficulty was in the range of 0.27-0.72; item discrimination was 0.30-0.75 with question No.3 being the exception (that was 0.24). The correlation between each item and the total score of CRP was 0.26-0.87; the correlation between CRPs test and MCQ test was 0.68 (p<0.001). The reliability of the CRPs was 0.72 as calculated by using Cronbach's alpha. The mean score of CRPs was different among residents based on their academic year and this difference was statistically significant (p<0.001). The results of this present investigation revealed that CRPs could be reliable test for measuring clinical

Role of routine abdominal ultrasonography in intensified tuberculosis case finding algorithms at HIV clinics in high TB burden settings.

PubMed

Spalgais, Sonam; Agarwal, Upasna; Sarin, Rohit; Chauhan, Devesh; Yadav, Anita; Jaiswal, Anand

2017-05-18

High proportion of TB in people living with HIV (PLHIV) is undiagnosed. Due to this active TB case finding is recommended for HIV clinics in high TB burden countries. Presently sputum examination and chest radiography are frontline tests recommended for HIV infected TB presumptives. Abdominal TB which occurs frequently in PLHIV may be missed even by existing programmatic intensified case finding protocols. This study evaluated the routine use of ultrasonography (USG) for active case finding of abdominal TB in HIV clinics. Retrospective analysis of eight years' data from an HIV Clinic in a TB hospital in India. Patients underwent chest x-ray, sputum examination, USG abdomen and routine blood tests at entry to HIV care. Case forms were scrutinized for diagnosis of TB, USG findings and CD4 cell counts. Abdominal TB was classified as probable or possible TB. Probable TB was based on presence of two major USG (abdomen) findings suggestive of active TB, or one major USG finding with at least two minor USG findings or at least two symptoms, or any USG finding with microbiologically confirmed active TB at another site. Possible TB was based on the presence of one major USG finding, or the presence of two minor USG findings with at least two symptoms. Bacteriological confirmation was not obtained. Eight hundred and eighty-nine people PLHIV underwent a baseline USG abdomen. One hundred and thirteen of 340 cases already diagnosed with TB and 87 of the 91 newly diagnosed with TB at time of HIV clinic registration had abdominal TB. Non-abdominal symptoms like weight loss, fever and cough were seen in 53% and 22% cases had no symptoms at all. Enlarged abdominal lymph nodes with central caseation, ascitis, splenic microabsesses, bowel thickening and hepatosplenomegaly were the USG findings in these cases. Abdominal TB is a frequent TB site in PLHIV presenting with non-abdominal symptoms. It can be easily detected on basis of features seen on a simple abdominal ultrasound

Simultaneous clustering of gene expression data with clinical chemistry and pathological evaluations reveals phenotypic prototypes

PubMed Central

Bushel, Pierre R; Wolfinger, Russell D; Gibson, Greg

2007-01-01

Background Commonly employed clustering methods for analysis of gene expression data do not directly incorporate phenotypic data about the samples. Furthermore, clustering of samples with known phenotypes is typically performed in an informal fashion. The inability of clustering algorithms to incorporate biological data in the grouping process can limit proper interpretation of the data and its underlying biology. Results We present a more formal approach, the modk-prototypes algorithm, for clustering biological samples based on simultaneously considering microarray gene expression data and classes of known phenotypic variables such as clinical chemistry evaluations and histopathologic observations. The strategy involves constructing an objective function with the sum of the squared Euclidean distances for numeric microarray and clinical chemistry data and simple matching for histopathology categorical values in order to measure dissimilarity of the samples. Separate weighting terms are used for microarray, clinical chemistry and histopathology measurements to control the influence of each data domain on the clustering of the samples. The dynamic validity index for numeric data was modified with a category utility measure for determining the number of clusters in the data sets. A cluster's prototype, formed from the mean of the values for numeric features and the mode of the categorical values of all the samples in the group, is representative of the phenotype of the cluster members. The approach is shown to work well with a simulated mixed data set and two real data examples containing numeric and categorical data types. One from a heart disease study and another from acetaminophen (an analgesic) exposure in rat liver that causes centrilobular necrosis. Conclusion The modk-prototypes algorithm partitioned the simulated data into clusters with samples in their respective class group and the heart disease samples into two groups (sick and buff denoting samples

Clinical routine utility of basophil activation testing for diagnosis of hymenoptera-allergic patients with emphasis on individuals with negative venom-specific IgE antibodies.

PubMed

Korošec, Peter; Šilar, Mira; Eržen, Renato; Čelesnik, Nina; Bajrović, Nissera; Zidarn, Mihaela; Košnik, Mitja

2013-01-01

Previous reports suggest the usefulness of basophil activation testing (BAT) in Hymenoptera-allergic patients with negative venom-specific IgE antibodies. We sought to evaluate the diagnostic utility of this testing in a routine clinical laboratory setting. Twenty-one patients with anaphylactic reactions to Hymenoptera sting (median grade III) and negative venom-specific IgE were routinely and prospectively tested with BAT. We were able to diagnose 81% (17 of 21) of patients with BAT and 57% (12 of 21) with intradermal skin testing. Three wasp venom-allergic patients showed IgE positivity to rVes v 5. Four patients (19%) were negative for all tests. In the case of double-positive BAT, the culprit insect correlated with the venom that induced a significantly higher basophil response. BAT allows the identification of severe Hymenoptera-allergic patients with negative specific IgE and skin tests. The routine use of this cellular test should facilitate prescription of venom immunotherapy in complex cases with inconclusive diagnostic results. Copyright © 2013 S. Karger AG, Basel.

The frequency and severity of capecitabine-induced hypertriglyceridaemia in routine clinical practice: a prospective study

PubMed Central

Michie, C O; Sakala, M; Rivans, I; Strachan, M W J; Clive, S

2010-01-01

Background: Capecitabine is known to rarely cause raised serum triglycerides (TG). In our centre, several patients receiving capecitabine developed raised TG levels corresponding to the ‘very high risk' category for potentially serious acute pancreatitis. Methods: A fasting blood lipid screening protocol was introduced into clinical practice for patients receiving capecitabine. Patients with TGs >5 mmol l−1 were treated and followed up. An 18-month prospective audit was performed to establish the incidence and severity of capecitabine-induced hypertriglyceridaemia (CIHT). Results: A total of 304 patients received capecitabine for colorectal cancer between January 2008 and June 2009. Of these, 212 patients (70%) were screened and 8 (3.7%) developed clinically significant hypertriglyceridaemia requiring lipid-lowering therapy. Two of the eight patients had diabetes and one had pre-existing dyslipidaemia. One suffered cerebral infarction during chemotherapy. There were no cases of acute pancreatitis. Follow-up showed that serum TGs safely and rapidly returned to normal with appropriate treatment without discontinuation of capecitabine. Conclusions: This is the first prospective study evaluating CIHT. These results suggest that it should be classed as a ‘common' undesired effect of capecitabine. Despite this, the incidence does not justify routine screening in all patients. Targeted screening in those with diabetes or pre-existing hyperlipidaemia is recommended, together with adoption of a clear management policy. PMID:20664584

Telemedicine Interest for Routine Follow-Up Care Among Neurology Patients in Arkansas.

PubMed

Bashiri, Maryam; Greenfield, L John; Oliveto, Alison

2016-06-01

Teleneurology in Arkansas has been used primarily for management of acute stroke with a state-funded hub-and-spoke model allowing physicians at rural hospitals to access vascular neurologists in time to facilitate tissue plasminogen activator administration. Routine neurologic care has been provided only in small pilot studies. We wished to determine patient interest in participating in teleneurology for routine follow-up visits as well as demographic and medical factors associated with interest. New and established patients of the Neurology Outpatient Clinic at the University of Arkansas for Medical Sciences (UAMS) were surveyed between March 2011 and December 2012 to assess their interest in participating in teleneurology as well as potential factors associated with their interest. Of 1,441 respondents, 52.4% were interested in telemedicine. Of those interested versus uninterested in telemedicine, respectively, 68.9% versus 36.32% traveled more than 1 h to the clinic, 64.7% versus 35.3% had difficulty secondary to neurological conditions, 22.6% versus 6.8% had missed medical appointments due to travel problems, and 43.1% versus 9.4% had travel-imposed financial hardship. Telemedicine interest for routine follow-up visits was strong among patients at the UAMS Neurology Outpatient Clinic. Factors positively associated with interest included long travel distances, travel expenses, and transportation difficulties. These results suggest that implementing a telemedicine program for follow-up visits would be acceptable to neurology patients for routine ongoing care.

Modern analytical chemistry in the contemporary world

NASA Astrophysics Data System (ADS)

Šíma, Jan

2016-12-01

Students not familiar with chemistry tend to misinterpret analytical chemistry as some kind of the sorcery where analytical chemists working as modern wizards handle magical black boxes able to provide fascinating results. However, this approach is evidently improper and misleading. Therefore, the position of modern analytical chemistry among sciences and in the contemporary world is discussed. Its interdisciplinary character and the necessity of the collaboration between analytical chemists and other experts in order to effectively solve the actual problems of the human society and the environment are emphasized. The importance of the analytical method validation in order to obtain the accurate and precise results is highlighted. The invalid results are not only useless; they can often be even fatal (e.g., in clinical laboratories). The curriculum of analytical chemistry at schools and universities is discussed. It is referred to be much broader than traditional equilibrium chemistry coupled with a simple description of individual analytical methods. Actually, the schooling of analytical chemistry should closely connect theory and practice.

Surface chemistry of carbon dioxide revisited

NASA Astrophysics Data System (ADS)

Taifan, William; Boily, Jean-François; Baltrusaitis, Jonas

2016-12-01

This review discusses modern developments in CO2 surface chemistry by focusing on the work published since the original review by H.J. Freund and M.W. Roberts two decades ago (Surface Science Reports 25 (1996) 225-273). It includes relevant fundamentals pertaining to the topics covered in that earlier review, such as conventional metal and metal oxide surfaces and CO2 interactions thereon. While UHV spectroscopy has routinely been applied for CO2 gas-solid interface analysis, the present work goes further by describing surface-CO2 interactions under elevated CO2 pressure on non-oxide surfaces, such as zeolites, sulfides, carbides and nitrides. Furthermore, it describes additional salient in situ techniques relevant to the resolution of the interfacial chemistry of CO2, notably infrared spectroscopy and state-of-the-art theoretical methods, currently used in the resolution of solid and soluble carbonate species in liquid-water vapor, liquid-solid and liquid-liquid interfaces. These techniques are directly relevant to fundamental, natural and technological settings, such as heterogeneous and environmental catalysis and CO2 sequestration.

The effectiveness of computer-generated 3D animations in inquiry chemistry laboratory

NASA Astrophysics Data System (ADS)

Theall, Rachel Morgan

It has been shown that students need a molecular-level understanding of substances in order to comprehend chemistry. For solid structures, atomic-level understanding requires students to learn additional and different concepts than for other states of matter. To aid understanding, animations were created to model unit cell structures and depict the properties of unit cells. In order to determine if these animations are helpful to students, they were tested during a laboratory exercise in which students had previously been using model kits and images from textbooks to learn about solid structures. Students evaluated in this study were from two lecture sections of general chemistry, one that routinely used animations during lecture and one that used a more traditional lecture format that did not include animations or models. Twelve laboratory sections of these lectures, taught by six different instructors each teaching two sections, were chosen for participation. One section for each instructor was given the animations as an optional tool for completing the laboratory assignment, which consisted of questions about unit cells and crystal structures. The results of the study indicate that students who looked at the animations performed significantly better on the assignment. For the control group, students who routinely viewed multiple representations of chemistry in lecture performed significantly better on the lab assignment than students in the lecture section where chemistry concepts were only presented on the chalkboard and overhead projector. Students in the traditional lecture section also had significantly less appreciation for the model kits used in the laboratory than students in the other lecture section. Observations of students in the lab combined with statistical results led to the revision of the solid structures investigation. Additional animations were created and inserted into the module that covered areas where students indicated more help was needed

[Routine fluoroscopic investigations after primary bariatric surgery].

PubMed

Gärtner, D; Ernst, A; Fedtke, K; Jenkner, J; Schöttler, A; Reimer, P; Blüher, M; Schön, M R

2016-03-01

Staple line and anastomotic leakages are life-threatening complications after bariatric surgery. Upper gastrointestinal (GI) tract X-ray examination with oral administration of a water-soluble contrast agent can be used to detect leaks. The aim of this study was to evaluate the impact of routine upper GI tract fluoroscopy after primary bariatric surgery. Between January 2009 and December 2014 a total of 658 bariatric interventions were carried out of which 442 were primary bariatric operations. Included in this single center study were 307 sleeve gastrectomies and 135 Roux-en-Y gastric bypasses. Up to December 2012 upper GI tract fluoroscopy was performed routinely between the first and third postoperative days and the detection of leakages was evaluated. In the investigation period 8 leakages (2.6 %) after sleeve gastrectomy, 1 anastomotic leakage in gastrojejunostomy and 1 in jejunojejunostomy after Roux-en-Y gastric bypass occurred. All patients developed clinical symptoms, such as abdominal pain, tachycardia or fever. In one case the leakage was detected by upper GI fluoroscopy and in nine cases radiological findings were unremarkable. No leakages were detected in asymptomatic patients. Routine upper GI fluoroscopy is not recommended for uneventful postoperative courses after primary bariatric surgery.

Molecular allergy diagnostics using multiplex assays: methodological and practical considerations for use in research and clinical routine: Part 21 of the Series Molecular Allergology.

PubMed

Jakob, Thilo; Forstenlechner, Peter; Matricardi, Paolo; Kleine-Tebbe, Jörg

The availability of single allergens and their use in microarray technology enables the simultaneous determination of specific IgE (sIgE) to a multitude of different allergens (> 100) in a multiplex procedure requiring only minute amounts of serum. This allows extensive individual sensitization profiles to be determined from a single analysis. Combined with a patient's medical history, these profiles simplify identification of cross-reactivity; permit a more accurate estimation of the risk of severe reactions; and enable the indication for specific immunotherapy to be more precisely established, particularly in cases of polysensitization. Strictly speaking, a multiplex assay is not a single test, but instead more than 100 simultaneous tests. This places considerable demands on the production, quality assurance, and interpretation of data. The following chapter describes the multiplex test systems currently available and discusses their characteristics. Performance data are presented and the sIgE values obtained from multiplex and singleplex assays are compared. Finally, the advantages and limitations of molecular allergy diagnostics using multiplex assays in clinical routine are discussed, and innovative possibilities for clinical research are described. The multiplex diagnostic tests available for clinical routine have now become well established. The interpretation of test results is demanding, particularly since all individual results need to be checked for their plausibility and clinical relevance on the basis of previous history (patient history, clinical symptoms, challenge test results). There is still room for improvement in certain areas, for example with respect to the overall test sensitivity of the method, as well as the availability and quality of particular allergens. The current test systems are just the beginning of a continuous development that will influence and most likely change clinical allergology in the coming years.

Predicting the evolution of low back pain patients in routine clinical practice: results from a registry within the Spanish National Health Service.

PubMed

Kovacs, Francisco M; Seco, Jesús; Royuela, Ana; Corcoll Reixach, Josep; Abraira, Víctor

2012-11-01

The Spanish National Health Service (SNHS) is a tax-funded public organization that provides free health care to every resident in Spain. To develop models for predicting the evolution of low back pain (LBP) in routine clinical practice within SNHS. Analysis of a prospective registry in routine clinical practice, in 17 centers across SNHS. Patient sample includes 4,477 acute and chronic LBP patients treated in primary and hospital care. Pain and disability, measured through validated instruments. Patients treated for LBP were assessed at baseline and 3 months later. Data gathered were the following: sex, age, employment status, duration of pain, severity of LBP, pain down to the leg (LP) and disability, history of lumbar surgery, diagnostic procedures undertaken, imaging findings, and treatments used throughout the study period. Three separate multivariate logistic regression models were developed for predicting a clinically relevant improvement in LBP, LP, and disability at 3 months. In total, 4,261 patients (95.2%) attended follow-up. For all the models, calibration was reasonable and the area under the receiver operating characteristic curve was ≥0.640. For LBP, LP, and disability, factors associated with a higher probability of improvement at 3 months were the following: not having undergone lumbar surgery, higher baseline scores for the corresponding variable, lower ones for the rest, and being treated with neuroreflexotherapy. Additional factors were the following: for LBP, shorter pain duration; for LP, not undergoing electromyography; and for disability, shorter pain duration, not being diagnosed with disc degeneration, and being treated with muscle relaxants and not opioids. A prospective registry can be used for developing predictive models to quantify the odds that a given LBP patient will experience a clinically relevant improvement. This may empower patients for an informed shared decision making. Copyright © 2012 Elsevier Inc. All rights reserved.

Is daily routine important for sleep? An investigation of social rhythms in a clinical insomnia population.

PubMed

Moss, Taryn G; Carney, Colleen E; Haynes, Patricia; Harris, Andrea L

2015-02-01

Social rhythms, also known as daily routines (e.g. exercise, of school or work, recreation, social activities), have been identified as potential time cues to help to regulate the biological clock. Past research has shown links between regularity and healthy sleep. This study examined the regularity and frequency of daytime activities in a clinical insomnia population and a good sleeper comparison group. Participants (N = 69) prospectively monitored their sleep and daily activities for a 2-week period. Although participants with insomnia and good sleepers had similar levels of activity, relative to good sleepers, those with insomnia were less regular in their activities. Findings from this study add to the growing number of studies that highlight the relative importance of the regularity of daytime activities on sleep. Accordingly, future research should test treatment components that focus on regulating daytime activities, which would likely improve treatment outcomes.

How do youth with experience of violence victimization and/or risk drinking perceive routine inquiry about violence and alcohol consumption in Swedish youth clinics? A qualitative study.

PubMed

Palm, Anna; Danielsson, Ingela; Högberg, Ulf; Norbergh, Karl-Gustav

2017-10-01

To explore perceptions and experiences among youth who underwent structured questions about violence victimization and alcohol consumption when visiting Swedish youth clinics. This study is part of a larger research project examining the effect of including routine inquiry about violence victimization and alcohol consumption for youth visiting youth clinics. Fifteen youth with experiences of victimization and/or risk drinking (AUDIT-C≥5) were interviewed. Content analysis was used. The findings were grouped into three main categories: The first; "Disclosure - talking about violence" reflected the participants' experiences of being asked about victimization. Participants were in favor of routine inquiry about violence victimization, even when questions caused distress. The questions helped participants reflect on prior victimization and process what had happened to them. The second; "Influence on the life situation" demonstrated that many of the participants still were effected by prior victimization, but also how talking about violence sometimes led to the possibility of initiating change such as leaving a destructive relationship or starting therapy. In the third; "One's own alcohol consumption in black and white" participants considered it natural to be asked about alcohol consumption. However, most participants did not consider their drinking problematic, even when told they exceeded guidelines. They viewed risk drinking in terms of immediate consequences rather than in quantity or frequency of alcohol intake. Routine inquiry about violence victimization and risk drinking at youth clinics was well received. Questions about violence helped participants to interpret and process prior victimization and sometimes initiated change. Copyright © 2017 Elsevier B.V. All rights reserved.

Promoting early presentation of breast cancer in older women: sustained effect of an intervention to promote breast cancer awareness in routine clinical practice.

PubMed

Dodd, Rachael H; Forster, Alice S; Sellars, Sarah; Patnick, Julietta; Ramirez, Amanda J; Forbes, Lindsay J L

2017-06-05

Older women have poorer survival from breast cancer, which may be at least partly due to poor breast cancer awareness leading to delayed presentation and more advanced stage at diagnosis. In a randomised trial, an intervention to promote early presentation of breast cancer in older women increased breast cancer awareness at 1 year compared with usual care (24 versus 4%). We examined its effectiveness in routine clinical practice. We piloted the intervention delivered by practising health professionals to women aged about 70 in four breast screening services. We measured the effect on breast cancer awareness at 1 year compared with comparison services, where women did not receive the intervention. At 1 year, 25% of women in pilot services were breast cancer aware compared with 4% in comparison services (p = 0.001). The components of breast cancer awareness were knowledge of breast cancer non-lump symptoms (pilot: 63% vs comparison: 82% at 1 year; OR = 2.56, 95% CI 1.92-3.42), knowledge of age related risk (pilot: 8% vs comparison: 36% at 1 year; OR = 5.56, 95% CI 4.0-7.74) and reported breast checking (pilot: 70% vs comparison: 78% at 1 year; OR = 1.49, 95% CI 1.13-1.96). The intervention may be as effective in routine clinical practice as in a randomised controlled trial. This intervention has the potential to reduce patient delay in the diagnosis of breast cancer in older women. The PEP trial was registered with the International Standard Registered Clinical/soCial sTudy Number (ISRCTN) as a clinical trial ( ISRCTN31994827 ) on 3rd October 2007.

Is heart rate variability better than routine vital signs for prehospital identification of major hemorrhage?

PubMed

Edla, Shwetha; Reisner, Andrew T; Liu, Jianbo; Convertino, Victor A; Carter, Robert; Reifman, Jaques

2015-02-01

During initial assessment of trauma patients, metrics of heart rate variability (HRV) have been associated with high-risk clinical conditions. Yet, despite numerous studies, the potential of HRV to improve clinical outcomes remains unclear. Our objective was to evaluate whether HRV metrics provide additional diagnostic information, beyond routine vital signs, for making a specific clinical assessment: identification of hemorrhaging patients who receive packed red blood cell (PRBC) transfusion. Adult prehospital trauma patients were analyzed retrospectively, excluding those who lacked a complete set of reliable vital signs and a clean electrocardiogram for computation of HRV metrics. We also excluded patients who did not survive to admission. The primary outcome was hemorrhagic injury plus different PRBC transfusion volumes. We performed multivariate regression analysis using HRV metrics and routine vital signs to test the hypothesis that HRV metrics could improve the diagnosis of hemorrhagic injury plus PRBC transfusion vs routine vital signs alone. As univariate predictors, HRV metrics in a data set of 402 subjects had comparable areas under receiver operating characteristic curves compared with routine vital signs. In multivariate regression models containing routine vital signs, HRV parameters were significant (P<.05) but yielded areas under receiver operating characteristic curves with minimal, nonsignificant improvements (+0.00 to +0.05). A novel diagnostic test should improve diagnostic thinking and allow for better decision making in a significant fraction of cases. Our findings do not support that HRV metrics add value over routine vital signs in terms of prehospital identification of hemorrhaging patients who receive PRBC transfusion. Published by Elsevier Inc.

Cyclophosphamide administration routine in autoimmune rheumatic diseases: a review.

PubMed

Teles, Kaian Amorim; Medeiros-Souza, Patricia; Lima, Francisco Aires Correa; Araújo, Bruno Gedeon de; Lima, Rodrigo Aires Correa

Cyclophosphamide is an alkylating agent widely used for the treatment of malignant neoplasia and which can be used in the treatment of multiple rheumatic diseases. Medication administration errors may lead to its reduced efficacy or increased drug toxicity. Many errors occur in the administration of injectable drugs. The present study aimed at structuring a routine for cyclophosphamide use, as well as creating a document with pharmacotherapeutic guidelines for the patient. The routine is schematized in three phases: pre-chemotherapy, administration of cyclophosphamide, and post-chemotherapy, taking into account the drugs to be administered before and after cyclophosphamide in order to prevent adverse effects, including nausea and hemorrhagic cystitis. Adverse reactions can alter laboratory tests; thus, this routine included clinical management for changes in white blood cells, platelets, neutrophils, and sodium, including cyclophosphamide dose adjustment in the case of kidney disease. Cyclophosphamide is responsible for other rare - but serious - side effects, for instance, hepatotoxicity, severe hyponatremia and heart failure. Other adverse reactions include hair loss, amenorrhea and menopause. In this routine, we also entered guidelines to post-chemotherapy patients. The compatibility of injectable drugs with the vehicle used has been described, as well as stability and infusion times. The routine aimed at the rational use of cyclophosphamide, with prevention of adverse events and relapse episodes, factors that may burden the health care system. Copyright © 2016 Elsevier Editora Ltda. All rights reserved.

Current Awareness and Use of the Strain Echocardiography in Routine Clinical Practices: Result of a Nationwide Survey in Korea.

PubMed

Lee, Ju-Hee; Park, Jae-Hyeong; Park, Seung Woo; Kim, Woo-Shik; Sohn, Il Suk; Chin, Jung Yeon; Cho, Jung Sun; Youn, Ho-Joong; Jung, Hae Ok; Lee, Sun Hwa; Kim, Seong-Hwan; Chung, Wook-Jin; Shim, Chi Young; Jeong, Jin-Won; Choi, Eui-Young; Rim, Se-Joong; Kim, Jang-Young; Kim, Kye Hun; Shin, Joon-Han; Kim, Dae-Hee; Jeon, Ung; Choi, Jung Hyun; Kim, Yong-Jin; Joo, Seung Jae; Kim, Ki-Hong; Cho, Kyoung Im; Cho, Goo-Yeong

2017-09-01

Because conventional echocardiographic parameters have several limitations, strain echocardiography has often been introduced in clinical practice. However, there are also obstacles in using it in clinical practice. Therefore, we wanted to find the current status of awareness on using strain echocardiography in Korea. We conducted a nationwide survey to evaluate current use and awareness of strain echocardiography from the members of the Korean Society of Echocardiography. We gathered total 321 questionnaires from 25 cardiology centers in Korea. All participants were able to perform or interpret echocardiographic examinations. All participating institutions performed strain echocardiography. Most of our study participants (97%) were aware of speckle tracking echocardiography and 185 (58%) performed it for clinical and research purposes. Two-dimensional strain echocardiography was the most commonly used modality and left ventricle (LV) was the most commonly used cardiac chamber (99%) for clinical purposes. Most of the participants (89%) did not think LV strain can replace LV ejection fraction (LVEF) in their clinical practice. The common reasons for not performing routine use of strain echocardiography was diversity of strain measurements and lack of normal reference value. Many participants had a favorable view of the future of strain echocardiography. Most of our study participants were aware of strain echocardiography, and all institutions performed strain echocardiography for clinical and research purposes. However, they did not think the LV strain values could replace LVEF. The diversity of strain measurements and lack of normal reference values were common reasons for not using strain echocardiography in clinical practice.

What is the value of routinely testing full blood count, electrolytes and urea, and pulmonary function tests before elective surgery in patients with no apparent clinical indication and in subgroups of patients with common comorbidities: a systematic review of the clinical and cost-effective literature.

PubMed

Czoski-Murray, C; Lloyd Jones, M; McCabe, C; Claxton, K; Oluboyede, Y; Roberts, J; Nicholl, J P; Rees, A; Reilly, C S; Young, D; Fleming, T

2012-12-01

The evidence base which supported the National Institute for Health and Clinical Excellence (NICE) published Clinical Guideline 3 was limited and 50% was graded as amber. However, the use of tests as part of pre-operative work-up remains a low-cost but high-volume activity within the NHS, with substantial resource implications. The objective of this study was to identify, evaluate and synthesise the published evidence on the clinical effectiveness and cost-effectiveness of the routine use of three tests, full blood counts (FBCs), urea and electrolytes tests (U&Es) and pulmonary function tests, in the pre-operative work-up of otherwise healthy patients undergoing minor or intermediate surgery in the NHS. The aims of this study were to estimate the clinical effectiveness and cost-effectiveness of routine pre-operative testing of FBC, electrolytes and renal function and pulmonary function in adult patients classified as American Society of Anaesthesiologists (ASA) grades 1 and 2 undergoing elective minor (grade 1) or intermediate (grade 2) surgical procedures; to compare NICE recommendations with current practice; to evaluate the cost-effectiveness of mandating or withdrawing each of these tests in this patient group; and to identify the expected value of information and whether or not it has value to the NHS in commissioning further primary research into the use of these tests in this group of patients. The following electronic bibliographic databases were searched: (1) BIOSIS; (2) Cumulative Index to Nursing and Allied Health Literature; (3) Cochrane Database of Systematic Reviews; (4) Cochrane Central Register of Controlled Trials; (5) EMBASE; (6) MEDLINE; (7) MEDLINE In-Process & Other Non-Indexed Citations; (8) NHS Database of Abstracts of Reviews of Effects; (9) NBS Health Technology Assessment Database; and (10) Science Citation Index. To identify grey and unpublished literature, the Cochrane Register of Controlled Trials, National Research Register Archive

ECHMERIT: A new on-line global mercury-chemistry model

NASA Astrophysics Data System (ADS)

Jung, G.; Hedgecock, I. M.; Pirrone, N.

2009-04-01

Mercury is a volatile metal, that is of concern because when deposited and transformed to methylmercury accumulates within the food-web. Due to the long lifetime of elemental mercury, which is the dominant fraction of mercury species in the atmosphere, mercury is prone to long-range transport and therefore distributed over the globe, transported and hence deposited even in regions far from anthropogenic emission sources. Mercury is released to the atmosphere from a variety of natural and anthropogenic sources, in elementary and oxidised forms, and as particulate mercury. It is then transported, but also transformed chemically in the gaseous phase, as well as in aqueous phase within cloud and rain droplets. Mercury (particularly its oxidised forms) is removed from the atmosphere though wet and dry deposition processes, a large fraction of deposited mercury is, after chemical or biological reduction, re-emitted to the atmosphere as elementary mercury. To investigate mercury chemistry and transport processes on the global scale, the new, global model ECHMERIT has been developed. ECHMERIT simulates meteorology, transport, deposition, photolysis and chemistry on-line. The general circulation model on which ECHMERIT is based is ECHAM5. Sophisticated chemical modules have been implemented, including gas phase chemistry based on the CBM-Z chemistry mechanism, as well as aqueous phase chemistry, both of which have been adapted to include Hg chemistry and Hg species gas-droplet mass transfer. ECHMERIT uses the fast-J photolysis routine. State-of-the-art procedures simulating wet and dry deposition and emissions were adapted and included in the model as well. An overview of the model structure, development, validation and sensitivity studies is presented.

Predictors and variation of routine home discharge in critically ill adults with cystic fibrosis.

PubMed

Oud, Lavi; Chan, Yiu Ming

2018-06-01

The short-term outcomes of patients with cystic fibrosis (CF) surviving critical illness were not examined systematically. To determine the factors associated with and variation in rates of routine home discharge among ICU-managed adult CF patients. Predictors of routine home discharge and its hospital-level variation were examined in ICU-managed adults with cystic fibrosis in Texas during 2004-2013. Older age, rural residence, and severity of illness decreased odds of routine home discharge, while hospitalization in facilities accredited as part of the Cystic Fibrosis Foundation Care Center Network nearly doubled the odds of routine home discharge. The median (interquartile) adjusted rate of routine home discharge was 62.0% (31.5-82.5). The identified determinants of routine home discharge can inform clinical decision-making, while the demonstrated wide variation in adjusted across-hospital rates of routine home discharge of ICU-managed adults with CF can provide benchmark data for future quality improvement efforts. Published by Elsevier Inc.

Routine Angiographic Follow-Up versus Clinical Follow-Up after Percutaneous Coronary Intervention in Acute Myocardial Infarction

PubMed Central

Kim, Yong Hoon; Her, Ae-Young; Choi, Byoung Geol; Shim, Minsuk; Choi, Se Yeon; Byun, Jae Kyeong; Li, Hu; Kim, Woohyeun; Kang, Jun Hyuk; Choi, Jah Yeon; Park, Eun Jin; Park, Sung Hun; Lee, Sunki; Na, Jin Oh; Choi, Cheol Ung; Lim, Hong Euy; Kim, Eung Ju; Park, Chang Gyu; Seo, Hong Seog; Oh, Dong Joo

2017-01-01

Purpose Differences in the utility of routine angiographic follow-up (RAF) and clinical follow-up (CF) after percutaneous coronary intervention (PCI) in acute myocardial infarction (AMI) are not well understood. The present study aimed to compare the 3-year clinical outcomes of RAF and CF in AMI patients who underwent PCI with drug-eluting stents (DES). Materials and Methods A total of 774 consecutive AMI patients who underwent PCI with DES were enrolled. RAF was performed at 6 to 9 months after index PCI (n=425). The remaining patients were medically managed and clinically followed (n=349); symptom-driven events were captured. To adjust for any potential confounders, a propensity score matched analysis was performed using a logistic regression model, and two propensity-matched groups (248 pairs, n=496, C-statistic=0.739) were generated. Cumulative clinical outcomes up to 3 years were compared between RAF and CF groups. Results During the 3-year follow-up period, the cumulative incidences of revascularization [target lesion revascularization: hazard ratio (HR), 2.40; 95% confidence interval (CI), 1.18–4.85; p=0.015, target vessel revascularization (TVR): HR, 3.33; 95% CI, 1.69–6.58; p=0.001, non-TVR: HR, 5.64; 95% CI, 1.90–16.6; p=0.002] and major adverse cardiac events (MACE; HR, 3.32; 95% CI, 1.92–5.73; p<0.001) were significantly higher in the RAF group than the CF group. However, the 3-year incidences of death and myocardial infarction were not different between the two groups. Conclusion RAF following index PCI with DES in AMI patients was associated with increased incidences of revascularization and MACE. Therefore, CF seems warranted for asymptomatic patients after PCI for AMI. PMID:28540983

A preliminary study of simple voice assessment in a routine clinical setting to predict vocal cord paralysis after thyroid or parathyroid surgery.

PubMed

Hanna, B C; Brooker, D S

2008-02-01

To determine if a simple assessment of vocal cord function performed in a routine clinical setting can predict vocal cord paralysis on laryngoscopy in patients following thyroid or parathyroid surgery. Prospective observational cohort study of patients undergoing thyroid or parathyroid surgery. Vocal cord function was assessed in terms of an abnormality of voice or cough reported by the patient or detected by the examiner. Laryngoscopy was performed by indirect mirror examination or fibreoptic nasopharyngolaryngoscopy. Examiners included otolaryngology consultants, registrars, senior house officers and a general practitioner with a special interest in otolaryngology. The patient was often examined by a different clinician before and after surgery. Eighty-six patients participated in the study between August 2003 and July 2004. Eleven had a change in their voice postoperatively and one patient had difficulty coughing. Six of these patients had a vocal cord paralysis. A further five apparently asymptomatic patients had a vocal cord paralysis. The positive predictive value of voice assessment for vocal cord paralysis was 55%. In a routine clinical setting where the assessment of vocal cord function is often reported by different clinicians of varying experience at each patient attendance, the assessment of a patient's voice following thyroid or parathyroid surgery is not adequately predictive of vocal cord paralysis on indirect laryngoscopy or fibreoptic nasopharyngolaryngoscopy. Further study is required to determine reasons for this.

Errors in the Extra-Analytical Phases of Clinical Chemistry Laboratory Testing.

PubMed

Zemlin, Annalise E

2018-04-01

The total testing process consists of various phases from the pre-preanalytical to the post-postanalytical phase, the so-called brain-to-brain loop. With improvements in analytical techniques and efficient quality control programmes, most laboratory errors now occur in the extra-analytical phases. There has been recent interest in these errors with numerous publications highlighting their effect on service delivery, patient care and cost. This interest has led to the formation of various working groups whose mission is to develop standardized quality indicators which can be used to measure the performance of service of these phases. This will eventually lead to the development of external quality assessment schemes to monitor these phases in agreement with ISO15189:2012 recommendations. This review focuses on potential errors in the extra-analytical phases of clinical chemistry laboratory testing, some of the studies performed to assess the severity and impact of these errors and processes that are in place to address these errors. The aim of this review is to highlight the importance of these errors for the requesting clinician.

Laboratory hematology in the history of Clinical Chemistry and Laboratory Medicine.

PubMed

Hoffmann, Johannes J M L

2013-01-01

For the occasion of the 50th anniversary of the journal Clinical Chemistry and Laboratory Medicine (CCLM), an historic overview of papers that the journal has published in the field of laboratory hematology (LH) is presented. All past volumes of CCLM were screened for papers on LH and these were categorized. Bibliographic data of these papers were also analyzed. CCLM published in total 387 LH papers. The absolute number of LH papers published annually showed a significant increase over the years since 1985. Also the share of LH papers demonstrated a steady increase (overall mean 5%, but mean 8% over the past 4 years). The most frequent category was coagulation and fibrinolysis (23.5%). Authors from Germany contributed the most LH papers to the journal (22.7%), followed by the Netherlands and Italy (16.3 and 13.2%, respectively). Recent citation data indicated that other publications cited LH review papers much more frequently than other types of papers. The history of the journal reflects the emergence and development of laboratory hematology as a separate discipline of laboratory medicine.

Chemokine Receptor CCR5 Antagonist Maraviroc: Medicinal Chemistry and Clinical Applications

PubMed Central

Xu, Guoyan G.; Guo, Jia; Wu, Yuntao

2015-01-01

The human immunodeficiency virus (HIV) causes acquired immumodeficiency syndrome (AIDS), one of the worst global pandemic. The virus infects human CD4 T cells and macrophages, and causes CD4 depletion. HIV enters target cells through the binding of the viral envelope glycoprotein to CD4 and the chemokine coreceptor, CXCR4 or CCR5. In particular, the CCR5-utilizing viruses predominate in the blood during the disease course. CCR5 is expressed on the surface of various immune cells including macrophages, monocytes, microglia, dendric cells, and active memory CD4 T cells. In the human population, the CCR5 genomic mutation, CCR5Δ32, is associated with relative resistance to HIV. These findings paved the way for the discovery and development of CCR5 inhibitors to block HIV transmission and replication. Maraviroc, discovered as a CCR5 antagonist, is the only CCR5 inhibitor that has been approved by both US FDA and the European Medicines Agency (EMA) for treating HIV/AIDS patients. In this review, we summarize the medicinal chemistry and clinical studies of Maraviroc. PMID:25159165

Industrial medicinal chemistry insights: neuroscience hit generation at Janssen.

PubMed

Tresadern, Gary; Rombouts, Frederik J R; Oehlrich, Daniel; Macdonald, Gregor; Trabanco, Andres A

2017-10-01

The role of medicinal chemistry has changed over the past 10 years. Chemistry had become one step in a process; funneling the output of high-throughput screening (HTS) on to the next stage. The goal to identify the ideal clinical compound remains, but the means to achieve this have changed. Modern medicinal chemistry is responsible for integrating innovation throughout early drug discovery, including new screening paradigms, computational approaches, novel synthetic chemistry, gene-family screening, investigating routes of delivery, and so on. In this Foundation Review, we show how a successful medicinal chemistry team has a broad impact and requires multidisciplinary expertise in these areas. Copyright © 2017 Elsevier Ltd. All rights reserved.

From supramolecular chemistry towards constitutional dynamic chemistry and adaptive chemistry.

PubMed

Lehn, Jean-Marie

2007-02-01

Supramolecular chemistry has developed over the last forty years as chemistry beyond the molecule. Starting with the investigation of the basis of molecular recognition, it has explored the implementation of molecular information in the programming of chemical systems towards self-organisation processes, that may occur either on the basis of design or with selection of their components. Supramolecular entities are by nature constitutionally dynamic by virtue of the lability of non-covalent interactions. Importing such features into molecular chemistry, through the introduction of reversible bonds into molecules, leads to the emergence of a constitutional dynamic chemistry, covering both the molecular and supramolecular levels. It considers chemical objects and systems capable of responding to external solicitations by modification of their constitution through component exchange or reorganisation. It thus opens the way towards an adaptive and evolutive chemistry, a further step towards the chemistry of complex matter.

Clinical chemistry measurements with commercially available test slides on a smartphone platform: Colorimetric determination of glucose and urea.

PubMed

Wu, Yuanyuan; Boonloed, Anukul; Sleszynski, Neal; Koesdjojo, Myra; Armstrong, Chadd; Bracha, Shay; Remcho, Vincent T

2015-08-25

Rapidly increasing healthcare costs in economically advantaged countries are currently unsustainable, while in many developing nations, even 50-year-old technologies are too expensive to implement. New and unconventional technologies are being explored as solutions to this problem. In this study, we examined the use of a smartphone as the detection platform for 2 well-developed, relatively inexpensive, commercially available clinical chemistry assays as a model for rapid and inexpensive clinical diagnostic testing. An Apple iPhone 4 camera phone equipped with a color analysis application (ColorAssist) was combined with Vitros® glucose and urea colorimetric assays. Color images of assay slides at various concentrations of glucose or urea were collected with the iPhone 4 and quantitated in three different spectral ranges (red/green/blue or RGB) using the ColorAssist app. When the diffuse reflectance data was converted into absorbance, it was possible to quantitate glucose or blood urea nitrogen (BUN) over their clinically important concentration ranges (30-515mg/dl for glucose or 2-190mg/dl for BUN), with good linearity (R(2)=0.9994 or 0.9996, respectively [n=5]). Data collected using the iPhone 4 and canine serum samples were in agreement with results from the instrumental "gold standard" (Beckman Coulter AU480 Chemistry System) (R(2)=0.9966 and slope=1.0001 for glucose; R(2)=0.9958 and slope=0.9454 for BUN). Glucose determinations of serum samples made using this smartphone method were as accurate as or more accurate than a commercial colorimetric dry slide analyzer (Heska® Element DC Chemistry Analyzer, Loveland, CO) and 2 glucometers: ReliOn® Ultima (Abbott Diabetes Care Inc) and Presto® (AgaMatrix Inc.H). BUN determinations made using the smartphone approach were comparable in accuracy to the Heska instrument. This demonstration shows that smartphones have the potential to be used as simple, effective colorimetric detectors for quantitative diagnostic tests

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.

Quantitative echocardiographic measures in the assessment of single ventricle function post-Fontan: Incorporation into routine clinical practice.

PubMed

Rios, Rodrigo; Ginde, Salil; Saudek, David; Loomba, Rohit S; Stelter, Jessica; Frommelt, Peter

2017-01-01

Quantitative echocardiographic measurements of single ventricular (SV) function have not been incorporated into routine clinical practice. A clinical protocol, which included quantitative measurements of SV deformation (global circumferential and longitudinal strain and strain rate), standard deviation of time to peak systolic strain, myocardial performance index (MPI), dP/dT from an atrioventricular valve regurgitant jet, and superior mesenteric artery resistance index, was instituted for all patients with a history of Fontan procedure undergoing echocardiography. All measures were performed real time during clinically indicated studies and were included in clinical reports. A total of 100 consecutive patients (mean age = 11.95±6.8 years, range 17 months-31.3 years) completed the protocol between September 1, 2014 to April 29, 2015. Deformation measures were completed in 100% of the studies, MPI in 93%, dP/dT in 55%, and superior mesenteric artery Doppler in 82%. The studies were reviewed to assess for efficiency in completing the protocol. The average time for image acquisition was 27.4±8.8 (range 10-62 minutes). The average time to perform deformation measures was 10.8±5.5 minutes (range 5-35 minutes) and time from beginning of imaging to report completion was 53.4±13.7 minutes (range 27-107 minutes). There was excellent inter-observer reliability when deformation indices were blindly repeated. Patients with a single left ventricle had significantly higher circumferential strain and strain rate, longitudinal strain and strain rate, and dP/dT compared to a single right ventricle. There were no differences in quantitative indices of ventricular function between patients <10 vs. >10 years post-Fontan. Advanced quantitative assessment of SV function post-Fontan can be consistently and efficiently performed real time during clinically indicated echocardiograms with excellent reliability. © 2016, Wiley Periodicals, Inc.

Matrix-assisted laser desorption ionization-time of flight mass spectrometry: a fundamental shift in the routine practice of clinical microbiology.

PubMed

Clark, Andrew E; Kaleta, Erin J; Arora, Amit; Wolk, Donna M

2013-07-01

Within the past decade, clinical microbiology laboratories experienced revolutionary changes in the way in which microorganisms are identified, moving away from slow, traditional microbial identification algorithms toward rapid molecular methods and mass spectrometry (MS). Historically, MS was clinically utilized as a high-complexity method adapted for protein-centered analysis of samples in chemistry and hematology laboratories. Today, matrix-assisted laser desorption ionization-time of flight (MALDI-TOF) MS is adapted for use in microbiology laboratories, where it serves as a paradigm-shifting, rapid, and robust method for accurate microbial identification. Multiple instrument platforms, marketed by well-established manufacturers, are beginning to displace automated phenotypic identification instruments and in some cases genetic sequence-based identification practices. This review summarizes the current position of MALDI-TOF MS in clinical research and in diagnostic clinical microbiology laboratories and serves as a primer to examine the "nuts and bolts" of MALDI-TOF MS, highlighting research associated with sample preparation, spectral analysis, and accuracy. Currently available MALDI-TOF MS hardware and software platforms that support the use of MALDI-TOF with direct and precultured specimens and integration of the technology into the laboratory workflow are also discussed. Finally, this review closes with a prospective view of the future of MALDI-TOF MS in the clinical microbiology laboratory to accelerate diagnosis and microbial identification to improve patient care.

Matrix-Assisted Laser Desorption Ionization–Time of Flight Mass Spectrometry: a Fundamental Shift in the Routine Practice of Clinical Microbiology

PubMed Central

Clark, Andrew E.; Kaleta, Erin J.; Arora, Amit

2013-01-01

SUMMARY Within the past decade, clinical microbiology laboratories experienced revolutionary changes in the way in which microorganisms are identified, moving away from slow, traditional microbial identification algorithms toward rapid molecular methods and mass spectrometry (MS). Historically, MS was clinically utilized as a high-complexity method adapted for protein-centered analysis of samples in chemistry and hematology laboratories. Today, matrix-assisted laser desorption ionization–time of flight (MALDI-TOF) MS is adapted for use in microbiology laboratories, where it serves as a paradigm-shifting, rapid, and robust method for accurate microbial identification. Multiple instrument platforms, marketed by well-established manufacturers, are beginning to displace automated phenotypic identification instruments and in some cases genetic sequence-based identification practices. This review summarizes the current position of MALDI-TOF MS in clinical research and in diagnostic clinical microbiology laboratories and serves as a primer to examine the “nuts and bolts” of MALDI-TOF MS, highlighting research associated with sample preparation, spectral analysis, and accuracy. Currently available MALDI-TOF MS hardware and software platforms that support the use of MALDI-TOF with direct and precultured specimens and integration of the technology into the laboratory workflow are also discussed. Finally, this review closes with a prospective view of the future of MALDI-TOF MS in the clinical microbiology laboratory to accelerate diagnosis and microbial identification to improve patient care. PMID:23824373

Clinical indicators for recurrent cardiovascular events in acute coronary syndrome patients treated with statins under routine practice in Thailand: an observational study.

PubMed

Chinwong, Dujrudee; Patumanond, Jayanton; Chinwong, Surarong; Siriwattana, Khanchai; Gunaparn, Siriluck; Hall, John Joseph; Phrommintikul, Arintaya

2015-06-16

Acute coronary syndrome (ACS) patients are at very high cardiovascular risk and tend to have recurrent cardiovascular events. The clinical indicators for subsequent cardiovascular events are limited and need further investigation. This study aimed to explore clinical indicators that were associated with recurrent cardiovascular events following index hospitalization. The data of patients hospitalized with ACS at a tertiary care hospital in northern Thailand between January 2009 and December 2012 were retrospectively reviewed from medical charts and the electronic hospital database. The patients were classified into three groups based on the frequency of recurrent cardiovascular events (nonfatal ACS, nonfatal stroke, or all-cause death) they suffered: no recurrent events (0), single recurrent event (1), and multiple recurrent events (≥2). Ordinal logistic regression was performed to explore the clinical indicators for recurrent cardiovascular events. A total of 405 patients were included; 60 % were male; the average age was 64.9 ± 11.5 years; 40 % underwent coronary revascularization during admission. Overall, 359 (88.6 %) had no recurrent events, 36 (8.9 %) had a single recurrent event, and 10 (2.5 %) had multiple recurrent events. The significant clinical indicators associated with recurrent cardiovascular events were achieving an LDL-C goal of < 70 mg/dL (Adjusted OR = 0.43; 95 % CI = 0.27-0.69, p-value < 0.001), undergoing revascularization during admission (Adjusted OR = 0.44; 95 % CI = 0.24-0.81, p-value = 0.009), being male (Adjusted OR = 1.85; 95 % CI = 1.29-2.66, p-value = 0.001), and decrease estimated glomerular filtration rate (Adjusted OR = 2.46; 95 % CI = 2.21-2.75, p-value < 0.001). The routine clinical practice indicators assessed in ACS patients that were associated with recurrent cardiovascular events were that achieving the LDL-C goal and revascularization are protective factors

The art and science of using routine outcome measurement in mental health benchmarking.

PubMed

McKay, Roderick; Coombs, Tim; Duerden, David

2014-02-01

To report and critique the application of routine outcome measurement data when benchmarking Australian mental health services. The experience of the authors as participants and facilitators of benchmarking activities is augmented by a review of the literature regarding mental health benchmarking in Australia. Although the published literature is limited, in practice, routine outcome measures, in particular the Health of the National Outcomes Scales (HoNOS) family of measures, are used in a variety of benchmarking activities. Use in exploring similarities and differences in consumers between services and the outcomes of care are illustrated. This requires the rigour of science in data management and interpretation, supplemented by the art that comes from clinical experience, a desire to reflect on clinical practice and the flexibility to use incomplete data to explore clinical practice. Routine outcome measurement data can be used in a variety of ways to support mental health benchmarking. With the increasing sophistication of information development in mental health, the opportunity to become involved in benchmarking will continue to increase. The techniques used during benchmarking and the insights gathered may prove useful to support reflection on practice by psychiatrists and other senior mental health clinicians.

The Use of Routine Postoperative Microscopy and Culture Screening Following Elective Hip and Knee Arthroplasty: An Unnecessary Cost With No Effect on Clinical Management?

PubMed

Kemp, Mark A; Martina, Ka; Collins, Claire L; Salmon, Lucy J; Gooden, Benjamin R; Lyons, Matthew C

2017-04-01

The use of microscopy and culture screening to detect pathogenic microorganisms followed by a decolonization protocol is a widely performed practice prior to elective hip and knee arthroplasty. In our center, the routine care of hip and knee arthroplasty also involves postoperative screening including direct culture of the surgical site. The aim of this study was to assess the frequency of pathogen detection following these tests and to determine whether routine postoperative screening, with particular reference to postoperative surgical site culture, led to any change in clinical management of these patients. A series of 1000 patients undergoing hip or knee arthroplasty at The Mater Hospital between January 2014 and December 2015 were identified from our arthroplasty database. Results of preoperative and postoperative microscopy and culture screening were reviewed by 2 independent researchers. Of the 1000 subjects, positive microscopy and culture results were identified in 88 patients (8.8%) preoperatively and 5 patients (0.5%) postoperatively. None of the 1000 postoperative surgical site swabs had a positive microscopy and culture screen. All the 5 positive postoperative microscopy and culture screen results were in patients who had positive cultures preoperatively. There were no positive postoperative microscopy and culture screen results in patients who had had negative preoperative results. Postoperative screening was performed at a cost of AUS$213 per patient. Routine postoperative surgical site culture following hip and knee arthroplasty does not alter clinical management, has a significant associated financial cost, and has the potential to expose the patient to a risk of surgical site infection and is therefore not supported. Copyright © 2016 Elsevier Inc. All rights reserved.

Constitutional dynamic chemistry: bridge from supramolecular chemistry to adaptive chemistry.

PubMed

Lehn, Jean-Marie

2012-01-01

Supramolecular chemistry aims at implementing highly complex chemical systems from molecular components held together by non-covalent intermolecular forces and effecting molecular recognition, catalysis and transport processes. A further step consists in the investigation of chemical systems undergoing self-organization, i.e. systems capable of spontaneously generating well-defined functional supramolecular architectures by self-assembly from their components, thus behaving as programmed chemical systems. Supramolecular chemistry is intrinsically a dynamic chemistry in view of the lability of the interactions connecting the molecular components of a supramolecular entity and the resulting ability of supramolecular species to exchange their constituents. The same holds for molecular chemistry when the molecular entity contains covalent bonds that may form and break reversibility, so as to allow a continuous change in constitution by reorganization and exchange of building blocks. These features define a Constitutional Dynamic Chemistry (CDC) on both the molecular and supramolecular levels.CDC introduces a paradigm shift with respect to constitutionally static chemistry. The latter relies on design for the generation of a target entity, whereas CDC takes advantage of dynamic diversity to allow variation and selection. The implementation of selection in chemistry introduces a fundamental change in outlook. Whereas self-organization by design strives to achieve full control over the output molecular or supramolecular entity by explicit programming, self-organization with selection operates on dynamic constitutional diversity in response to either internal or external factors to achieve adaptation.The merging of the features: -information and programmability, -dynamics and reversibility, -constitution and structural diversity, points to the emergence of adaptive and evolutive chemistry, towards a chemistry of complex matter.

Can machine-learning improve cardiovascular risk prediction using routine clinical data?

PubMed Central

Kai, Joe; Garibaldi, Jonathan M.; Qureshi, Nadeem

2017-01-01

Background Current approaches to predict cardiovascular risk fail to identify many people who would benefit from preventive treatment, while others receive unnecessary intervention. Machine-learning offers opportunity to improve accuracy by exploiting complex interactions between risk factors. We assessed whether machine-learning can improve cardiovascular risk prediction. Methods Prospective cohort study using routine clinical data of 378,256 patients from UK family practices, free from cardiovascular disease at outset. Four machine-learning algorithms (random forest, logistic regression, gradient boosting machines, neural networks) were compared to an established algorithm (American College of Cardiology guidelines) to predict first cardiovascular event over 10-years. Predictive accuracy was assessed by area under the ‘receiver operating curve’ (AUC); and sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) to predict 7.5% cardiovascular risk (threshold for initiating statins). Findings 24,970 incident cardiovascular events (6.6%) occurred. Compared to the established risk prediction algorithm (AUC 0.728, 95% CI 0.723–0.735), machine-learning algorithms improved prediction: random forest +1.7% (AUC 0.745, 95% CI 0.739–0.750), logistic regression +3.2% (AUC 0.760, 95% CI 0.755–0.766), gradient boosting +3.3% (AUC 0.761, 95% CI 0.755–0.766), neural networks +3.6% (AUC 0.764, 95% CI 0.759–0.769). The highest achieving (neural networks) algorithm predicted 4,998/7,404 cases (sensitivity 67.5%, PPV 18.4%) and 53,458/75,585 non-cases (specificity 70.7%, NPV 95.7%), correctly predicting 355 (+7.6%) more patients who developed cardiovascular disease compared to the established algorithm. Conclusions Machine-learning significantly improves accuracy of cardiovascular risk prediction, increasing the number of patients identified who could benefit from preventive treatment, while avoiding unnecessary treatment of others

Can machine-learning improve cardiovascular risk prediction using routine clinical data?

PubMed

Weng, Stephen F; Reps, Jenna; Kai, Joe; Garibaldi, Jonathan M; Qureshi, Nadeem

2017-01-01

Current approaches to predict cardiovascular risk fail to identify many people who would benefit from preventive treatment, while others receive unnecessary intervention. Machine-learning offers opportunity to improve accuracy by exploiting complex interactions between risk factors. We assessed whether machine-learning can improve cardiovascular risk prediction. Prospective cohort study using routine clinical data of 378,256 patients from UK family practices, free from cardiovascular disease at outset. Four machine-learning algorithms (random forest, logistic regression, gradient boosting machines, neural networks) were compared to an established algorithm (American College of Cardiology guidelines) to predict first cardiovascular event over 10-years. Predictive accuracy was assessed by area under the 'receiver operating curve' (AUC); and sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) to predict 7.5% cardiovascular risk (threshold for initiating statins). 24,970 incident cardiovascular events (6.6%) occurred. Compared to the established risk prediction algorithm (AUC 0.728, 95% CI 0.723-0.735), machine-learning algorithms improved prediction: random forest +1.7% (AUC 0.745, 95% CI 0.739-0.750), logistic regression +3.2% (AUC 0.760, 95% CI 0.755-0.766), gradient boosting +3.3% (AUC 0.761, 95% CI 0.755-0.766), neural networks +3.6% (AUC 0.764, 95% CI 0.759-0.769). The highest achieving (neural networks) algorithm predicted 4,998/7,404 cases (sensitivity 67.5%, PPV 18.4%) and 53,458/75,585 non-cases (specificity 70.7%, NPV 95.7%), correctly predicting 355 (+7.6%) more patients who developed cardiovascular disease compared to the established algorithm. Machine-learning significantly improves accuracy of cardiovascular risk prediction, increasing the number of patients identified who could benefit from preventive treatment, while avoiding unnecessary treatment of others.

[COPD routine management in France: are guidelines used in clinical practice?].

PubMed

Jebrak, G

2010-01-01

COPD management guidelines have been proposed to improve the major outcomes for COPD patients. In clinical practice, COPD treatment is only partially consistent with current guidelines and recommendations. Global initiative for chronic obstructive lung disease (GOLD) guidelines are based on a COPD severity scale and are subject to change as the evidence based evolves. The main purpose of our study was to access whether the treatments prescribed to patients with COPD were consistent with these guidelines. Treatments prescribed by French physicians to 542 patients with COPD in stable conditions were recorded according to the severity of obstruction, using GOLD classification. We compared our prescription data base with the GOLD guidelines. Forty percent of the initial physicians were chest specialists. 78.3 % men, (64.8+/-10.8years) and 25 % were still smokers at inclusion. We found an important discrepancy between recommended treatment and COPD severity. Bronchodilators were commonly prescribed, but 11 % in severe COPD (stages III and IV) did not receive them. Inhaled steroids (ICS) were used respectively in 55.2 %, 59.4 % of patients in stages I, II (FEV1>50 %) (for whom they are not recommended) and 77.4 and 85.3 % in stages III and IV. Only 30 % of patients used ICS+beta2 agonists in the same device. Influenza vaccination had been performed in only half of patients whatever the severity of COPD. Pulmonary rehabilitation had been used by 10 % of patients, (stage II: 6.4 %, stage III: 9.6 %, stage IV: 20.6 %). We confirmed that there are discrepancies between COPD guidelines and routine treatments. Some treatments such as ICS were overused in mild phenotypes, whereas in a high proportion of cases influenza immunisation and rehabilitation were omitted.

Design and implementation of a controlled clinical trial to evaluate the effectiveness and efficiency of routine opt-out rapid human immunodeficiency virus screening in the emergency department.

PubMed

Haukoos, Jason S; Hopkins, Emily; Byyny, Richard L; Conroy, Amy A; Silverman, Morgan; Eisert, Sheri; Thrun, Mark; Wilson, Michael; Boyett, Brian; Heffelfinger, James D

2009-08-01

In 2006, the Centers for Disease Control and Prevention (CDC) released revised recommendations for performing human immunodeficiency virus (HIV) testing in health care settings, including implementing routine rapid HIV screening, the use of an integrated opt-out consent, and limited prevention counseling. Emergency departments (EDs) have been a primary focus of these efforts. These revised CDC recommendations were primarily based on feasibility studies and have not been evaluated through the application of rigorous research methods. This article describes the design and implementation of a large prospective controlled clinical trial to evaluate the CDC's recommendations in an ED setting. From April 15, 2007, through April 15, 2009, a prospective quasi-experimental equivalent time-samples clinical trial was performed to compare the clinical effectiveness and efficiency of routine (nontargeted) opt-out rapid HIV screening (intervention) to physician-directed diagnostic rapid HIV testing (control) in a high-volume urban ED. In addition, three nested observational studies were performed to evaluate the cost-effectiveness and patient and staff acceptance of the two rapid HIV testing methods. This article describes the rationale, methodologies, and study design features of this program evaluation clinical trial. It also provides details regarding the integration of the principal clinical trial and its nested observational studies. Such ED-based trials are rare, but serve to provide valid comparisons between testing approaches. Investigators should consider similar methodology when performing future ED-based health services research.

The gallium melting-point standard: its role in manufacture and quality control of electronic thermometers for the clinical laboratory.

PubMed

Sostman, H E

1977-01-01

I discuss the traceability of calibration of electronic thermometers to thermometric constants of nature or to the National Bureau of Standards, form a manufacturer's basic standards through the manufacturing process to the user's laboratory. Useful electrical temperature sensors, their advantages, and means for resolving their disadvantages are described. I summarize our development of a cell for realizing the melting phase equilibrium of pure gallium (at 29.770 degrees C) as a thermometer calibration fixed point, and enumerate its advantages in the routine calibration verification of electrical thermometers in the clinical chemistry laboratory.

A Nursing Intelligence System to Support Secondary Use of Nursing Routine Data

PubMed Central

Rauchegger, F.; Ammenwerth, E.

2015-01-01

Summary Background Nursing care is facing exponential growth of information from nursing documentation. This amount of electronically available data collected routinely opens up new opportunities for secondary use. Objectives To present a case study of a nursing intelligence system for reusing routinely collected nursing documentation data for multiple purposes, including quality management of nursing care. Methods The SPIRIT framework for systematically planning the reuse of clinical routine data was leveraged to design a nursing intelligence system which then was implemented using open source tools in a large university hospital group following the spiral model of software engineering. Results The nursing intelligence system is in routine use now and updated regularly, and includes over 40 million data sets. It allows the outcome and quality analysis of data related to the nursing process. Conclusions Following a systematic approach for planning and designing a solution for reusing routine care data appeared to be successful. The resulting nursing intelligence system is useful in practice now, but remains malleable for future changes. PMID:26171085

The Diagnostic Value of Routine Contrast Esophagram in Anastomotic Leaks After Esophagectomy.

PubMed

Hu, Zhongwu; Wang, Xiaowe; An, Xush; Li, Wenjin; Feng, Yun; You, Zhenbing

2017-08-01

Routine contrast esophagram has been shown to be increasingly limited in diagnosing anastomotic leaks after esophagectomy. Patients undergoing esophagectomy from 2013 to 2014 at Huai'an First Peoples' Hospital were identified. We retrospectively analyzed patients who underwent routine contrast esophagram on postoperative day 7 (range 6-10) to preclude anastomotic leaks after esophagectomy. In 846 patients who underwent esophagectomy, a cervical anastomosis was performed in 286 patients and an intrathoracic anastomosis in 560 patients. There were 57 (6.73%) cases with anastomotic leaks, including cervical leaks in 36 and intrathoracic leaks in 21 patients. In the cervical anastomotic leak patients, 13 were diagnosed by early local clinical symptoms and 23 underwent routine contrast esophagram. There were 7 (30.4%) true-positive, 11 (47.8%) false-negative, and five (21.8%) equivocal cases. In the intrathoracic anastomotic leak patients, four (19%) were diagnosed by clinical symptoms, 16 (76.2%) were true positives, and one (4.8%) was a false negative. Aspiration occurred in five patients with cervical anastomoses and in eight patients with intrathoracic anastomoses; aspiration pneumonitis did not occur in these cases. Gastrografin and barium are safe contrast agents to use in post-esophagectomy contrast esophagram. Because of the low sensitivity in detecting cervical anastomotic leaks, routine contrast esophagram is not advised. For patients with intrathoracic anastomoses, it is still an effective method for detecting anastomotic leaks.

Impact of routine cerebral CT angiography on treatment decisions in infective endocarditis.

PubMed

Meshaal, Marwa Sayed; Kassem, Hussein Heshmat; Samir, Ahmad; Zakaria, Ayman; Baghdady, Yasser; Rizk, Hussein Hassan

2015-01-01

Infective endocarditis (IE) is commonly complicated by cerebral embolization and hemorrhage secondary to intracranial mycotic aneurysms (ICMAs). These complications are associated with poor outcome and may require diagnostic and therapeutic plans to be modified. However, routine screening by brain CT and CT angiography (CTA) is not standard practice. We aimed to study the impact of routine cerebral CTA on treatment decisions for patients with IE. From July 2007 to December 2012, we prospectively recruited 81 consecutive patients with definite left-sided IE according to modified Duke's criteria. All patients had routine brain CTA conducted within one week of admission. All patients with ICMA underwent four-vessel conventional angiography. Invasive treatment was performed for ruptured aneurysms, aneurysms ≥ 5 mm, and persistent aneurysms despite appropriate therapy. Surgical clipping was performed for leaking aneurysms if not amenable to intervention. The mean age was 30.43 ± 8.8 years and 60.5% were males. Staph aureus was the most common organism (32.3%). Among the patients, 37% had underlying rheumatic heart disease, 26% had prosthetic valves, 23.5% developed IE on top of a structurally normal heart and 8.6% had underlying congenital heart disease. Brain CT/CTA revealed that 51 patients had evidence of cerebral embolization, of them 17 were clinically silent. Twenty-six patients (32%) had ICMA, of whom 15 were clinically silent. Among the patients with ICMAs, 11 underwent endovascular treatment and 2 underwent neurovascular surgery. The brain CTA findings prompted different treatment choices in 21 patients (25.6%). The choices were aneurysm treatment before cardiac surgery rather than at follow-up, valve replacement by biological valve instead of mechanical valve, and withholding anticoagulation in patients with prosthetic valve endocarditis for fear of aneurysm rupture. Routine brain CT/CTA resulted in changes in the treatment plan in a significant proportion

Uniform data collection in routine clinical practice in cardiovascular patients for optimal care, quality control and research: The Utrecht Cardiovascular Cohort.

PubMed

Asselbergs, Folkert W; Visseren, Frank Lj; Bots, Michiel L; de Borst, Gert J; Buijsrogge, Marc P; Dieleman, Jan M; van Dinther, Baukje Gf; Doevendans, Pieter A; Hoefer, Imo E; Hollander, Monika; de Jong, Pim A; Koenen, Steven V; Pasterkamp, Gerard; Ruigrok, Ynte M; van der Schouw, Yvonne T; Verhaar, Marianne C; Grobbee, Diederick E

2017-05-01

Background Cardiovascular disease remains the major contributor to morbidity and mortality. In routine care for patients with an elevated cardiovascular risk or with symptomatic cardiovascular disease information is mostly collected in an unstructured manner, making the data of limited use for structural feedback, quality control, learning and scientific research. Objective The Utrecht Cardiovascular Cohort (UCC) initiative aims to create an infrastructure for uniform registration of cardiovascular information in routine clinical practice for patients referred for cardiovascular care at the University Medical Center Utrecht, the Netherlands. This infrastructure will promote optimal care according to guidelines, continuous quality control in a learning healthcare system and creation of a research database. Methods The UCC comprises three parts. UCC-1 comprises enrolment of all eligible cardiovascular patients in whom the same information will be collected, based on the Dutch cardiovascular management guideline. A sample of UCC-1 will be invited for UCC-2. UCC-2 involves an enrichment through extensive clinical measurements with emphasis on heart failure, cerebral ischaemia, arterial aneurysms, diabetes mellitus and elevated blood pressure. UCC-3 comprises on-top studies, with in-depth measurements in smaller groups of participants typically based on dedicated project grants. All participants are followed up for morbidity and mortality through linkage with national registries. Conclusion In a multidisciplinary effort with physicians, patients and researchers the UCC sets a benchmark for a learning cardiovascular healthcare system. UCC offers an invaluable resource for future high quality care as well as for first-class research for investigators.

Physicians slow to e-mail routinely with patients.

PubMed

Boukus, Ellyn R; Grossman, Joy M; O'Malley, Ann S

2010-10-01

Some experts view e-mail between physicians and patients as a potential tool to improve physician-patient communication and, ultimately, patient care. Despite indications that many patients want to e-mail their physicians, physician adoption and use of e-mail with patients remains uncommon--only 6.7 percent of office-based physicians routinely e-mailed patients in 2008, according to a new national study from the Center for Studying Health System Change (HSC). Overall, about one-third of office-based physicians reported that information technology (IT) was available in their practice for e-mailing patients about clinical issues. Of those, fewer than one in five reported using e-mail with patients routinely; the remaining physicians were roughly evenly split between occasional users and non-users. Physicians in practices with access to electronic medical records and those working in health maintenance organizations (HMOs) or medical school settings were more likely to adopt and use e-mail to communicate with patients compared with other physicians. However, even among the highest users--physicians in group/staff-model HMOs--only 50.6 percent reported routinely e-mailing patients.

Computer Based Instructional Techniques in Undergraduate Introductory Organic Chemistry: Rationale, Developmental Techniques, Programming Strategies and Evaluation.

ERIC Educational Resources Information Center

Culp, G. H.; And Others

Over 100 interactive computer programs for use in general and organic chemistry at the University of Texas at Austin have been prepared. The rationale for the programs is based upon the belief that computer-assisted instruction (CAI) can improve education by, among other things, freeing teachers from routine tasks, measuring entry skills,…

Design and Development of Microcontroller-Based Clinical Chemistry Analyser for Measurement of Various Blood Biochemistry Parameters

PubMed Central

Taneja, S. R.; Kumar, Jagdish; Thariyan, K. K.; Verma, Sanjeev

2005-01-01

Clinical chemistry analyser is a high-performance microcontroller-based photometric biochemical analyser to measure various blood biochemical parameters such as blood glucose, urea, protein, bilirubin, and so forth, and also to measure and observe enzyme growth occurred while performing the other biochemical tests such as ALT (alkaline amino transferase), amylase, AST (aspartate amino transferase), and so forth. These tests are of great significance in biochemistry and used for diagnostic purposes and classifying various disorders and diseases such as diabetes, liver malfunctioning, renal diseases, and so forth. An inexpensive clinical chemistry analyser developed by the authors is described in this paper. This is an open system in which any reagent kit available in the market can be used. The system is based on the principle of absorbance transmittance photometry. System design is based around 80C31 microcontroller with RAM, EPROM, and peripheral interface devices. The developed system incorporates light source, an optical module, interference filters of various wave lengths, peltier device for maintaining required temperature of the mixture in flow cell, peristaltic pump for sample aspiration, graphic LCD display for displaying blood parameters, patients test results and kinetic test graph, 40 columns mini thermal printer, and also 32-key keyboard for executing various functions. The lab tests conducted on the instrument include versatility of the analyzer, flexibility of the software, and treatment of sample. The prototype was tested and evaluated over 1000 blood samples successfully for seventeen blood parameters. Evaluation was carried out at Government Medical College and Hospital, the Department of Biochemistry. The test results were found to be comparable with other standard instruments. PMID:18924737

Design and development of microcontroller-based clinical chemistry analyser for measurement of various blood biochemistry parameters.

PubMed

Taneja, S R; Gupta, R C; Kumar, Jagdish; Thariyan, K K; Verma, Sanjeev

2005-01-01

Clinical chemistry analyser is a high-performance microcontroller-based photometric biochemical analyser to measure various blood biochemical parameters such as blood glucose, urea, protein, bilirubin, and so forth, and also to measure and observe enzyme growth occurred while performing the other biochemical tests such as ALT (alkaline amino transferase), amylase, AST (aspartate amino transferase), and so forth. These tests are of great significance in biochemistry and used for diagnostic purposes and classifying various disorders and diseases such as diabetes, liver malfunctioning, renal diseases, and so forth. An inexpensive clinical chemistry analyser developed by the authors is described in this paper. This is an open system in which any reagent kit available in the market can be used. The system is based on the principle of absorbance transmittance photometry. System design is based around 80C31 microcontroller with RAM, EPROM, and peripheral interface devices. The developed system incorporates light source, an optical module, interference filters of various wave lengths, peltier device for maintaining required temperature of the mixture in flow cell, peristaltic pump for sample aspiration, graphic LCD display for displaying blood parameters, patients test results and kinetic test graph, 40 columns mini thermal printer, and also 32-key keyboard for executing various functions. The lab tests conducted on the instrument include versatility of the analyzer, flexibility of the software, and treatment of sample. The prototype was tested and evaluated over 1000 blood samples successfully for seventeen blood parameters. Evaluation was carried out at Government Medical College and Hospital, the Department of Biochemistry. The test results were found to be comparable with other standard instruments.

Haematology and plasma chemistry of the red top ice blue mbuna cichlid (Metriaclima greshakei).

PubMed

Snellgrove, Donna L; Alexander, Lucille G

2011-10-01

Clinical haematology and blood plasma chemistry can be used as a valuable tool to provide substantial diagnostic information for fish. A wide range of parameters can be used to assess nutritional status, digestive function, disease identification, routine metabolic levels, general physiological status and even the assessment and management of wild fish populations. However to evaluate such data accurately, baseline reference intervals for each measurable parameter must be established for the species of fish in question. Baseline data for ornamental fish species are limited, as research is more commonly conducted using commercially cultured fish. Blood samples were collected from sixteen red top ice blue cichlids (Metriaclima greshakei), an ornamental freshwater fish, to describe a range of haematology and plasma chemistry parameters. Since this cichlid is fairly large in comparison with most tropical ornamental fish, two independent blood samples were taken to assess a large range of parameters. No significant differences were noted between sample periods for any parameter. Values obtained for a large number of parameters were similar to those established for other closely related fish species such as tilapia (Oreochromis spp.). In addition to reporting the first set of blood values for M. Greshakei, to our knowledge, this study highlights the possibility of using previously established data for cultured cichlid species in studies with ornamental cichlid fish.

What is the yield of routine chest radiography following tube thoracostomy for trauma?

PubMed

Kong, Victor Y; Oosthuizen, George V; Clarke, Damian L

2015-01-01

Routine chest radiography (CXR) following tube thoracostomy (TT) is a standard practice in most trauma centres worldwide. Evidence supporting this routine practice is lacking and the actual yield is unknown. We performed a retrospective review of 1042 patients over a 4-year period who had a routine post-insertion CXR performed in accordance with current ATLS® recommendations. A total 1042 TTs were performed on 1004 patients. Ninety-one per cent of patients (913/1004) were males, and the median age for all patients was 24 years. Seventy-five per cent of all injuries (756/1004) were from penetrating trauma, and the remaining 25% (248/1004) were from blunt. The initial pathologies requiring TT were: haemopneumothorax: 34% (339/1042), haemothroax: 31% (314/1042), simple pneumothorax: 25% (256/1042), tension pneumothorax: 8% (77/1042) and open pneumothorax: 5% (54/1042). One hundred and three patients had TTs performed on clinical grounds alone without a pre-insertion CXR [Group A]. One hundred and ninety-one patients had a pre-insertion CXR but had persistent clinical concerns following insertion [Group B]. Seven hundred and ten patients had pre-insertion CXR but no clinical concerns following insertion [Group C]. Overall, 15% (152/1004) [9 from Group A, 111 from Group B and 32 from Group C] of all patients had their clinical management influenced as a direct result of the post-insertion CXR. Despite the widely accepted practice of routine CXR following tube thoracostomy, the yield is relatively low. In many cases, good clinical examination post tube insertion will provide warnings as to whether problems are likely to result. However, in the more rural setting, and in resource challenged environments, there is a relatively high yield from the CXR, which alters management. Further prospective studies are needed to establish or refute the role of the existing ATLS® guidelines in these specific environments. Copyright © 2014 Elsevier Ltd. All rights reserved.

Reliability of shear wave ultrasound elastography for neck lesions identified in routine clinical practice.

PubMed

Bhatia, K; Tong, C S L; Cho, C C M; Yuen, E H Y; Lee, J; Ahuja, A T

2012-10-01

To evaluate the reliability of shear wave ultrasound elastography (SWE) in the neck. 176 neck lesions (40 thyroid, 56 lymph nodes, 46 salivary, 34 miscellaneous) identified in a routine US clinic underwent SWE by one or two blinded radiologists. For this study, SWE required the operator to acquire three 10 second dynamic colour-coded SWE cineloops per lesion, select one static image per cineloop, and place circular regions-of-interest within the entire lesion and stiffest part to generate 3 SWE measurements per static image. For logistical reasons, one radiologist evaluated all 176 lesions and the other evaluated 58 lesions. Both radiologists also reviewed 27 archived cineloops independently to assess SWE excluding practical technique. Reliability was assessed using intraclass correlation coefficients (ICCs) concordance correlation coefficients (CCCs) and coefficients of repeatability (CORs). Test-retest ICCs for the radiologist evaluating 176 lesions were 0.78 - 0.85 (fair-excellent agreement), CCCs were 0.85 - 0.88 (substantial agreement), and CORs were 14.9 - 36.1 kPa. For both radiologists evaluating 58 lesions, intra-rater and inter-rater ICCs were 0.65 - 0.78 and 0.72 - 0.77 respectively. For SWE excluding practical technique, inter-rater ICCs were 0.97 - 0.98 (excellent agreement). ICCs differed according to tissue, being higher in thyroid lesions than lymph nodes (p < 0.001), and higher in benign than malignant lesions (p values < 0.001). Intra- and inter-rater reliability of SWE is fair to excellent according to ICCs. SWE reliability is influenced appreciably by acquisition technique. Nevertheless, CORs for SWE are not negligible. To determine whether these results are acceptable clinically, further research is required to establish SWE stiffness values of normal and pathological tissues in the neck. © Georg Thieme Verlag KG Stuttgart · New York.

The chemistry of PET imaging with zirconium-89.

PubMed

Dilworth, Jonathan R; Pascu, Sofia I

2018-04-23

This Tutorial Review aims to provide an overview of the use of zirconium-89 complexes in biomedical imaging. Over the past decade there have been many new papers in this field, ranging from chemistry through to preclinical and clinical applications. Here we attempt to summarise the main developments that have occurred in this period. The primary focus is on coordination chemistry but other aspects such as isotope production, isotope properties, handling and radiochemical techniques and characterisation of cold and labelled complexes are included. Selected results from animal and human clinical studies are presented in the context of the stabilities and properties of the labelled bioconjugates.

Fasting is not routinely required for determination of a lipid profile: clinical and laboratory implications including flagging at desirable concentration cut-points-a joint consensus statement from the European Atherosclerosis Society and European Federation of Clinical Chemistry and Laboratory Medicine.

PubMed

Nordestgaard, Børge G; Langsted, Anne; Mora, Samia; Kolovou, Genovefa; Baum, Hannsjörg; Bruckert, Eric; Watts, Gerald F; Sypniewska, Grazyna; Wiklund, Olov; Borén, Jan; Chapman, M John; Cobbaert, Christa; Descamps, Olivier S; von Eckardstein, Arnold; Kamstrup, Pia R; Pulkki, Kari; Kronenberg, Florian; Remaley, Alan T; Rifai, Nader; Ros, Emilio; Langlois, Michel

2016-07-01

To critically evaluate the clinical implications of the use of non-fasting rather than fasting lipid profiles and to provide guidance for the laboratory reporting of abnormal non-fasting or fasting lipid profiles. Extensive observational data, in which random non-fasting lipid profiles have been compared with those determined under fasting conditions, indicate that the maximal mean changes at 1-6 h after habitual meals are not clinically significant [+0.3 mmol/L (26 mg/dL) for triglycerides; -0.2 mmol/L (8 mg/dL) for total cholesterol; -0.2 mmol/L (8 mg/dL) for LDL cholesterol; +0.2 mmol/L (8 mg/dL) for calculated remnant cholesterol; -0.2 mmol/L (8 mg/dL) for calculated non-HDL cholesterol]; concentrations of HDL cholesterol, apolipoprotein A1, apolipoprotein B, and lipoprotein(a) are not affected by fasting/non-fasting status. In addition, non-fasting and fasting concentrations vary similarly over time and are comparable in the prediction of cardiovascular disease. To improve patient compliance with lipid testing, we therefore recommend the routine use of non-fasting lipid profiles, while fasting sampling may be considered when non-fasting triglycerides >5 mmol/L (440 mg/dL). For non-fasting samples, laboratory reports should flag abnormal concentrations as triglycerides ≥2 mmol/L (175 mg/dL), total cholesterol ≥5 mmol/L (190 mg/dL), LDL cholesterol ≥3 mmol/L (115 mg/dL), calculated remnant cholesterol ≥0.9 mmol/L (35 mg/dL), calculated non-HDL cholesterol ≥3.9 mmol/L (150 mg/dL), HDL cholesterol ≤1 mmol/L (40 mg/dL), apolipoprotein A1 ≤1.25 g/L (125 mg/dL), apolipoprotein B ≥1.0 g/L (100 mg/dL), and lipoprotein(a) ≥50 mg/dL (80th percentile); for fasting samples, abnormal concentrations correspond to triglycerides ≥1.7 mmol/L (150 mg/dL). Life-threatening concentrations require separate referral when triglycerides >10 mmol/L (880 mg/dL) for the risk of pancreatitis, LDL cholesterol >13 mmol/L (500 mg/dL) for homozygous familial

Fasting is not routinely required for determination of a lipid profile: clinical and laboratory implications including flagging at desirable concentration cut-points—a joint consensus statement from the European Atherosclerosis Society and European Federation of Clinical Chemistry and Laboratory Medicine

PubMed Central

Nordestgaard, Børge G.; Langsted, Anne; Mora, Samia; Kolovou, Genovefa; Baum, Hannsjörg; Bruckert, Eric; Watts, Gerald F.; Sypniewska, Grazyna; Wiklund, Olov; Borén, Jan; Chapman, M. John; Cobbaert, Christa; Descamps, Olivier S.; von Eckardstein, Arnold; Kamstrup, Pia R.; Pulkki, Kari; Kronenberg, Florian; Remaley, Alan T.; Rifai, Nader; Ros, Emilio; Langlois, Michel

2016-01-01

Abstract Aims To critically evaluate the clinical implications of the use of non-fasting rather than fasting lipid profiles and to provide guidance for the laboratory reporting of abnormal non-fasting or fasting lipid profiles. Methods and results Extensive observational data, in which random non-fasting lipid profiles have been compared with those determined under fasting conditions, indicate that the maximal mean changes at 1–6 h after habitual meals are not clinically significant [+0.3 mmol/L (26 mg/dL) for triglycerides; −0.2 mmol/L (8 mg/dL) for total cholesterol; −0.2 mmol/L (8 mg/dL) for LDL cholesterol; +0.2 mmol/L (8 mg/dL) for calculated remnant cholesterol; −0.2 mmol/L (8 mg/dL) for calculated non-HDL cholesterol]; concentrations of HDL cholesterol, apolipoprotein A1, apolipoprotein B, and lipoprotein(a) are not affected by fasting/non-fasting status. In addition, non-fasting and fasting concentrations vary similarly over time and are comparable in the prediction of cardiovascular disease. To improve patient compliance with lipid testing, we therefore recommend the routine use of non-fasting lipid profiles, while fasting sampling may be considered when non-fasting triglycerides >5 mmol/L (440 mg/dL). For non-fasting samples, laboratory reports should flag abnormal concentrations as triglycerides ≥2 mmol/L (175 mg/dL), total cholesterol ≥5 mmol/L (190 mg/dL), LDL cholesterol ≥3 mmol/L (115 mg/dL), calculated remnant cholesterol ≥0.9 mmol/L (35 mg/dL), calculated non-HDL cholesterol ≥3.9 mmol/L (150 mg/dL), HDL cholesterol ≤1 mmol/L (40 mg/dL), apolipoprotein A1 ≤1.25 g/L (125 mg/dL), apolipoprotein B ≥1.0 g/L (100 mg/dL), and lipoprotein(a) ≥50 mg/dL (80th percentile); for fasting samples, abnormal concentrations correspond to triglycerides ≥1.7 mmol/L (150 mg/dL). Life-threatening concentrations require separate referral when triglycerides >10 mmol/L (880 mg/dL) for the risk of pancreatitis, LDL cholesterol >13 mmol/L (500 mg

Effectiveness and cost of atypical versus typical antipsychotic treatment for schizophrenia in routine care.

PubMed

Stargardt, Tom; Weinbrenner, Susanne; Busse, Reinhard; Juckel, Georg; Gericke, Christian A

2008-06-01

In two recent randomised clinical trials, a meta-analysis and in an effectiveness study analysing routine data from the U.S. Veterans Administration the superiority of the newer atypical drugs over typical antipsychotic drugs, concerning both their efficacy and their side-effect profile, has been questioned. To analyse the effectiveness and cost of atypical versus typical antipsychotic treatment for schizophrenia in routine care. Cohort study using routine care data from a statutory sickness fund with 5.4 million insured in Germany. To be included, patients had to be discharged with a diagnosis of schizophrenia in 2003 and fulfil membership criteria. Main outcome measures were rehospitalisation rates, mean hospital bed days, mean length of stay, cost of inpatient and pharmaceutical care to the sickness fund during follow-up and medication used to treat side-effects. 3121 patients were included into the study. There were no statistically significant differences in the effectiveness of atypical and typical antipsychotics on rehospitalisation during follow-up (rehospitalisation rate ratio 1.07, 95% confidence interval 0.86 to 1.33). However, there were consistent observations of atypical antipsychotics being more effective for severe cases of schizophrenia (14.6% of study population; >61 prior bed days per year in 2000-2002) in the follow-up period, whereas for the other severity strata typical antipsychotics seemed more effective in reducing various rehospitalisation outcomes. Patients treated with atypical antipsychotics received significantly less prescriptions for anticholinergics or tiaprid (relative risk 0.26, 95% confidence interval 0.18 to 0.38). The effectiveness of atypical antipsychotics for schizophrenia on rehospitalisation measures appeared similar to that of typical antipsychotics. With the exception of severe cases, the higher costs for atypical antipsychotics were not offset by savings from reduced inpatient care. Major limitations include the lack of

Extrapulmonary involvement in patients with sarcoidosis and comparison of routine laboratory and clinical data to pulmonary involvement.

PubMed

Zurkova, Monika; Kolek, Vitezslav; Tomankova, Tereza; Kriegova, Eva

2014-12-01

Patients with pulmonary and pulmonary plus extrapulmonary sarcoidosis differ in symptom severity and health status impairment. To date there is no information on differences in clinical and laboratory parameters between these phenotypes and limited information on extrapulmonary involvement in Czech sarcoidosis patients exists. We therefore compared clinical data (age, gender, organ involvement, lung function tests) and laboratory data (blood counts, bronchoalveolar fluid (BAL) cellular profile, serum levels of CRP, SACE, sIL-2R, neopterin) between patients with newly diagnosed pulmonary sarcoidosis (n=107) and those with pulmonary plus extrapulmonary sarcoidosis (n=54). Extrapulmonary sarcoidosis was diagnosed in 33% of patients, mostly affecting lymph nodes and skin and having hypercalciuria. There was no difference in the prevalence of extrapulmonary sarcoidosis between genders. Patients with extrapulmonary sarcoidosis were older and mostly non-smokers when compared to those with limited pulmonary form. X-ray Stage I and erythema nodosum were less frequent in extrapulmonary disease. Serum levels of CRP, SACE, sIL-2R and neopterin and BAL cellular profile did not differ between both phenotypes. We observed lower platelets, FEV1, VC, and BAL CD19+ in females with extrapulmonary involvement than in those with pulmonary disease. Affected lymph nodes, skin and hypercalciuria were the most common in sarcoidosis patients with extrapulmonary involvement. Pulmonary sarcoidosis did not differ in clinical and routine laboratory parameters from pulmonary plus extrapulmonary sarcoidosis. Observation of low platelets, VC, FEV1 and BAL CD19+ in females with extrapulmonary sarcoidosis needs further verification in larger cohort.

Reference values for 27 clinical chemistry tests in 70-year-old males and females.

PubMed

Carlsson, Lena; Lind, Lars; Larsson, Anders

2010-01-01

Reference values are usually defined based on blood samples from healthy men or nonpregnant women in the age range of 20-50 years. These values are not optimal for elderly patients, as many biological markers change over time and adequate reference values are important for correct clinical decisions. To validate NORIP (Nordic Reference Interval Project) reference values in a 70-year-old population. We studied 27 frequently used laboratory tests. The 2.5th and 97.5th percentiles for these markers were calculated according to the recommendations of the International Federation of Clinical Chemistry on the statistical treatment of reference values. Reference values are reported for plasma alanine aminotransferase, albumin, alkaline phosphatase, pancreas amylase, apolipoprotein A1, apolipoprotein B, aspartate aminotransferase, bilirubin, calcium, chloride, cholesterol, creatinine, creatine kinase, C-reactive protein, glucose, gamma-glutamyltransferase, HDL-cholesterol, iron, lactate dehydrogenase, LDL-cholesterol, magnesium, phosphate, potassium, sodium, transferrin, triglycerides, urate and urea. Reference values calculated from the whole population and a subpopulation without cardiovascular disease showed strong concordance. Several of the reference interval limits were outside the 90% CI of a Scandinavian population (NORIP). 2009 S. Karger AG, Basel.

Increased Exposure to Rigid Routines can Lead to Increased Challenging Behavior Following Changes to Those Routines.

PubMed

Bull, Leah E; Oliver, Chris; Callaghan, Eleanor; Woodcock, Kate A

2015-06-01

Several neurodevelopmental disorders are associated with preference for routine and challenging behavior following changes to routines. We examine individuals with Prader-Willi syndrome, who show elevated levels of this behavior, to better understand how previous experience of a routine can affect challenging behavior elicited by disruption to that routine. Play based challenges exposed 16 participants to routines, which were either adhered to or changed. Temper outburst behaviors, heart rate and movement were measured. As participants were exposed to routines for longer before a change (between 10 and 80 min; within participants), more temper outburst behaviors were elicited by changes. Increased emotional arousal was also elicited, which was indexed by heart rate increases not driven by movement. Further study will be important to understand whether current intervention approaches that limit exposure to changes, may benefit from the structured integration of flexibility to ensure that the opportunity for routine establishment is also limited.

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.

Outcome measures in European patients with haemophilia: Survey of implementation in routine clinical practice, perception of relevance and recommendations by European treaters in the EHTSB.

PubMed

Hermans, C; Klamroth, R; Richards, M; de Moerloose, P; Garrido, R P

2017-03-01

This study was conducted to evaluate the current implementation of outcome measures in routine clinical haemophilia practice and to explore and appreciate the perception of the relevance of such measures by treaters. A survey was completed by 19 of the 26 physicians involved in the European Haemophilia Therapy Strategy Board (EHTSB). Employing an extensive inventory of outcome measures used in patients with haemophilia, information was collected about the frequency of data collection and the subjective appreciation of their importance during clinic review. The survey revealed that most treaters currently collect data that are mainly related to the haemostatic treatment (consumption of concentrates) and the bleeding symptoms (number and location of bleeds) in a non-uniform and non-standardized way. By contrast, functional, physical and quality of life scorings are rarely used and show considerable heterogeneity between treaters. Also, many disparities emerged between practice and perception, in particular quality of life data that are perceived as being important but for most of the time are not collected. This survey represents, in our view, the first attempt to evaluate the actual utilization of outcome measures in haemophilia care. While the value of outcome measures is appreciated, they are not assessed regularly. Therefore, there is a need to include appropriate performance indicators (outcome measures) of haemophilia care in routine clinical practice. Consensus recommendations to provide a framework for achieving this aim are provided. © 2016 John Wiley & Sons Ltd.

Daily life activity routine discovery in hemiparetic rehabilitation patients using topic models.

PubMed

Seiter, J; Derungs, A; Schuster-Amft, C; Amft, O; Tröster, G

2015-01-01

Monitoring natural behavior and activity routines of hemiparetic rehabilitation patients across the day can provide valuable progress information for therapists and patients and contribute to an optimized rehabilitation process. In particular, continuous patient monitoring could add type, frequency and duration of daily life activity routines and hence complement standard clinical scores that are assessed for particular tasks only. Machine learning methods have been applied to infer activity routines from sensor data. However, supervised methods require activity annotations to build recognition models and thus require extensive patient supervision. Discovery methods, including topic models could provide patient routine information and deal with variability in activity and movement performance across patients. Topic models have been used to discover characteristic activity routine patterns of healthy individuals using activity primitives recognized from supervised sensor data. Yet, the applicability of topic models for hemiparetic rehabilitation patients and techniques to derive activity primitives without supervision needs to be addressed. We investigate, 1) whether a topic model-based activity routine discovery framework can infer activity routines of rehabilitation patients from wearable motion sensor data. 2) We compare the performance of our topic model-based activity routine discovery using rule-based and clustering-based activity vocabulary. We analyze the activity routine discovery in a dataset recorded with 11 hemiparetic rehabilitation patients during up to ten full recording days per individual in an ambulatory daycare rehabilitation center using wearable motion sensors attached to both wrists and the non-affected thigh. We introduce and compare rule-based and clustering-based activity vocabulary to process statistical and frequency acceleration features to activity words. Activity words were used for activity routine pattern discovery using topic models

An examination of the usefulness of repeat testing practices in a large hospital clinical chemistry laboratory.

PubMed

Deetz, Carl O; Nolan, Debra K; Scott, Mitchell G

2012-01-01

A long-standing practice in clinical laboratories has been to automatically repeat laboratory tests when values trigger automated "repeat rules" in the laboratory information system such as a critical test result. We examined 25,553 repeated laboratory values for 30 common chemistry tests from December 1, 2010, to February 28, 2011, to determine whether this practice is necessary and whether it may be possible to reduce repeat testing to improve efficiency and turnaround time for reporting critical values. An "error" was defined to occur when the difference between the initial and verified values exceeded the College of American Pathologists/Clinical Laboratory Improvement Amendments allowable error limit. The initial values from 2.6% of all repeated tests (668) were errors. Of these 668 errors, only 102 occurred for values within the analytic measurement range. Median delays in reporting critical values owing to repeated testing ranged from 5 (blood gases) to 17 (glucose) minutes.

Quality Assurance in Clinical Chemistry: A Touch of Statistics and A Lot of Common Sense

PubMed Central

2016-01-01

Summary Working in laboratories of clinical chemistry, we risk feeling that our personal contribution to quality is small and that statistical models and manufacturers play the major roles. It is seldom sufficiently acknowledged that personal knowledge, skills and common sense are crucial for quality assurance in the interest of patients. The employees, environment and procedures inherent to the laboratory including its interactions with the clients are crucial for the overall result of the total testing chain. As the measurement systems, reagents and procedures are gradually improved, work on the preanalytical, postanalytical and clinical phases is likely to pay the most substantial dividends in accomplishing further quality improvements. This means changing attitudes and behaviour, especially of the users of the laboratory. It requires understanding people and how to engage them in joint improvement processes. We need to use our knowledge and common sense expanded with new skills e.g. from the humanities, management, business and change sciences in order to bring this about together with the users of the laboratory. PMID:28356868

Development and analysis of an instrument to assess student understanding of GOB chemistry knowledge relevant to clinical nursing practice.

PubMed

Brown, Corina E; Hyslop, Richard M; Barbera, Jack

2015-01-01

The General, Organic, and Biological Chemistry Knowledge Assessment (GOB-CKA) is a multiple-choice instrument designed to assess students' understanding of the chemistry topics deemed important to clinical nursing practice. This manuscript describes the development process of the individual items along with a psychometric evaluation of the final version of the items and instrument. In developing items for the GOB-CKA, essential topics were identified through a series of expert interviews (with practicing nurses, nurse educators, and GOB chemistry instructors) and confirmed through a national survey. Individual items were tested in qualitative studies with students from the target population for clarity and wording. Data from pilot and beta studies were used to evaluate each item and narrow the total item count to 45. A psychometric analysis performed on data from the 45-item final version was used to provide evidence of validity and reliability. The final version of the instrument has a Cronbach's alpha value of 0.76. Feedback from an expert panel provided evidence of face and content validity. Convergent validity was estimated by comparing the results from the GOB-CKA with the General-Organic-Biochemistry Exam (Form 2007) of the American Chemical Society. Instructors who wish to use the GOB-CKA for teaching and research may contact the corresponding author for a copy of the instrument. © 2014 Wiley Periodicals, Inc.

Prevalence and Clinical Correlates of a Short Onset REM Period (SOREMP) during Routine PSG

PubMed Central

Cairns, Alyssa; Bogan, Richard

2015-01-01

(PSG) short onset REM peroid (SOREMP) for the diagnosis of narcolepsy may be altered by a history of shift/night work and/ or other factors that may allow for a rebound of REM sleep (e.g., undergoing a positive airway pressure titration), supporting published guidelines that other sleep disorders and insufficient and/or poorly timed sleep should be ruled out and/or adequately controlled for prior to conducting sleep testing. Further research is needed to understand racial differences in PSG SOREMP and narcolepsy. This study was limited in that data on cataplexy (with exception to that in final diagnosis) and habitual sleep duration were not available. Citation: Cairns A, Bogan R. Prevalence and clinical correlates of a short onset REM period (SOREMP) during routine PSG. SLEEP 2015;38(10):1575–1581. PMID:26039966

HERALD (health economics using routine anonymised linked data).

PubMed

Husain, Muhammad J; Brophy, Sinead; Macey, Steven; Pinder, Leila M; Atkinson, Mark D; Cooksey, Roxanne; Phillips, Ceri J; Siebert, Stefan

2012-03-29

Health economic analysis traditionally relies on patient derived questionnaire data, routine datasets, and outcomes data from experimental randomised control trials and other clinical studies, which are generally used as stand-alone datasets. Herein, we outline the potential implications of linking these datasets to give one single joined up data-resource for health economic analysis. The linkage of individual level data from questionnaires with routinely-captured health care data allows the entire patient journey to be mapped both retrospectively and prospectively. We illustrate this with examples from an Ankylosing Spondylitis (AS) cohort by linking patient reported study dataset with the routinely collected general practitioner (GP) data, inpatient (IP) and outpatient (OP) datasets, and Accident and Emergency department data in Wales. The linked data system allows: (1) retrospective and prospective tracking of patient pathways through multiple healthcare facilities; (2) validation and clarification of patient-reported recall data, complementing the questionnaire/routine data information; (3) obtaining objective measure of the costs of chronic conditions for a longer time horizon, and during the pre-diagnosis period; (4) assessment of health service usage, referral histories, prescribed drugs and co-morbidities; and (5) profiling and stratification of patients relating to disease manifestation, lifestyles, co-morbidities, and associated costs. Using the GP data system we tracked about 183 AS patients retrospectively and prospectively from the date of questionnaire completion to gather the following information: (a) number of GP events; (b) presence of a GP 'drug' read codes; and (c) the presence of a GP 'diagnostic' read codes. We tracked 236 and 296 AS patients through the OP and IP data systems respectively to count the number of OP visits; and IP admissions and duration. The results are presented under several patient stratification schemes based on disease

Clinical biochemistry education in Spain.

PubMed

Queraltó, J M

1994-12-31

Clinical biochemistry in Spain was first established in 1978 as an independent specialty. It is one of several clinical laboratory sciences specialties, together with haematology, microbiology, immunology and general laboratory (Clinical analysis, análisis clinicos). Graduates in Medicine, Pharmacy, Chemistry and Biological Sciences can enter post-graduate training in Clinical Chemistry after a nation-wide examination. Training in an accredited Clinical Chemistry department is 4 years. A national committee for medical and pharmacist specialties advises the government on the number of trainees, program and educational units accreditation criteria. Technical staff includes nurses and specifically trained technologists. Accreditation of laboratories is developed at different regional levels. The Spanish Society for Clinical Biochemistry and Molecular Pathology (SECQ), the national representative in the IFCC, has 1600 members, currently publishes a scientific journal (Química Clinica) and a newsletter. It organizes a continuous education program, a quality control program and an annual Congress.

The clinical utility of the Cornell Scale for Depression in Dementia as a routine assessment in nursing homes.

PubMed

Jeon, Yun-Hee; Li, Zhicheng; Low, Lee-Fay; Chenoweth, Lynn; O'Connor, Daniel; Beattie, Elizabeth; Liu, Zhixin; Brodaty, Henry

2015-08-01

To examine the clinical utility of the Cornell Scale for Depression in Dementia (CSDD) in nursing homes. 14 nursing homes in Sydney and Brisbane, Australia. 92 residents with a mean age of 85 years. Consenting residents were assessed by care staff for depression using the CSDD as part of their routine assessment. Specialist clinicians conducted assessment of depression using the Semi-structured Clinical Diagnostic Interview for DSM-IV-TR Axis I Disorders for residents without dementia or the Provisional Diagnostic Criteria for Depression in Alzheimer Disease for residents with dementia to establish expert clinical diagnoses of depression. The diagnostic performance of the staff completed CSDD was analyzed against expert diagnosis using receiver operating characteristic (ROC) curves. The CSDD showed low diagnostic accuracy, with areas under the ROC curve being 0.69, 0.68 and 0.70 for the total sample, residents with dementia and residents without dementia, respectively. At the standard CSDD cutoff score, the sensitivity and specificity were 71% and 59% for the total sample, 69% and 57% for residents with dementia, and 75% and 61% for residents without dementia. The Youden index (for optimizing cut-points) suggested different depression cutoff scores for residents with and without dementia. When administered by nursing home staff the clinical utility of the CSDD is highly questionable in identifying depression. The complexity of the scale, the time required for collecting relevant information, and staff skills and knowledge of assessing depression in older people must be considered when using the CSDD in nursing homes. Copyright © 2015 American Association for Geriatric Psychiatry. Published by Elsevier Inc. All rights reserved.

Implementation of a cystic fibrosis lung transplant referral patient decision aid in routine clinical practice: an observational study.

PubMed

Stacey, Dawn; Vandemheen, Katherine L; Hennessey, Rosamund; Gooyers, Tracy; Gaudet, Ena; Mallick, Ranjeeta; Salgado, Josette; Freitag, Andreas; Berthiaume, Yves; Brown, Neil; Aaron, Shawn D

2015-02-07

continued to feel inadequate ability with supporting patients to handle conflicting views (p = 0.01). Most Canadian CF clinics agreed to participate in the study. Interventions were used to target identified modifiable barriers to using the patient decision aid in routine CF clinical practice. CF clinics reported using it with almost all patients in the second year.

Utility of routine versus selective upper gastrointestinal series to detect anastomotic leaks after laparoscopic gastric bypass.

PubMed

Schiesser, Marc; Guber, Josef; Wildi, Stefan; Guber, Ivo; Weber, Markus; Muller, Markus K

2011-08-01

In up to 4% of laparoscopic Roux-en-Y gastric bypass (LRYGB) procedures, anastomotic leaks occur. Early detection of gastrointestinal leakage is important for successful treatment. Consequently, many centers advocate routine postoperative upper gastrointestinal (UGI) series. The aim of this study was to determine the utility of this practice after LRYGB. Eight hundred four consecutive patients undergoing LRYGB from June 2000 to April 2010 were analyzed prospectively. The first 382 patients received routine UGI series between the third and fifth postoperative days (group A). Thereafter, the test was only performed when clinical findings (tachycardia, fever, and drainage content) were suspicious for a leak of the gastrointestinal anastomosis (group B; n = 422). Overall, nine of 804 (1.1%) patients suffered from leaks at the gastroenterostomy. In group A, four of 382 (1%) patients had a leak, but only two were detected by the routine UGI series. This corresponds to a sensitivity of 50%. In group B, the sensitivity was higher with 80%. Specificities were comparable with 97% and 91%, respectively. Routine UGI series cost only 1.6% of the overall costs of a non-complicated gastric bypass procedure. With this leak rate and sensitivity, US $86,800 would have to be spent on 200 routine UGI series to find one leak which is not justified. This study shows that routine UGI series have a low sensitivity for the detection of anastomotic leaks after LRYGB. In most cases, the diagnosis is initiated by clinical findings. Therefore, routine upper gastrointestinal series are of limited value for the diagnosis of a leak.

Transitioning couple's voluntary HIV counseling and testing (CVCT) from stand-alone weekend services into routine antenatal and VCT services in government clinics in Zambia's two largest cities.

PubMed

Inambao, Mubiana; Kilembe, William; Canary, Lauren A; Czaicki, Nancy L; Kakungu-Simpungwe, Matilda; Chavuma, Roy; Wall, Kristin M; Tichacek, Amanda; Pulerwitz, Julie; Thior, Ibou; Chomba, Elwyn; Allen, Susan A

2017-01-01

Most HIV infections in Africa are acquired by married/cohabiting adults and WHO recommends couple's voluntary HIV counseling and testing (CVCT) for prevention. The handover from NGO-sponsored weekend CVCT to government-sponsored services in routine weekday antenatal care (ANC) and individual voluntary testing and counseling (VCT) services in Zambia's two largest cities from 2009-2015 is described. Government clinic counselors were trained to provide CVCT, and along with community health workers they promoted CVCT services in their clinic and surrounding areas. When client volume exceeded the capacity of on-duty staff in ANC and VCT, non-governmental organization (NGO) subsidies were offered for overtime pay. Implementation of routine CVCT services varied greatly by clinic and city. The 12 highest volume clinics were examined further, while 13 clinics had CVCT numbers that were too low to warrant further investigation. In Lusaka, the proportion of pregnant women whose partners were tested rose from 2.6% in 2009 to a peak of 26.2% in 2012 and 24.8% in 2015. Corresponding reports in Ndola were 2.0% in 2009, 17.0% in 2012 and 14.5% in 2015. Obstacles to CVCT included: limited space and staffing, competing priorities, record keeping not adapted for couples, and few resources for promotion and increasing male involvement. Conflicting training models for 'partner testing' with men and women separately vs. CVCT with joint post-test counseling led to confusion in reporting to district health authorities. A focused and sustained effort will be required to reach a meaningful number of couples with CVCT to prevent heterosexual and perinatal HIV transmission. Establishing targets and timelines, funding for dedicated and appropriately trained staff, adoption of standardized data recording instruments with couple-level indicators, and expansion of community and clinic-based promotions using proven models are recommended.

Medicinal chemistry for 2020

PubMed Central

Satyanarayanajois, Seetharama D; Hill, Ronald A

2011-01-01

Rapid advances in our collective understanding of biomolecular structure and, in concert, of biochemical systems, coupled with developments in computational methods, have massively impacted the field of medicinal chemistry over the past two decades, with even greater changes appearing on the horizon. In this perspective, we endeavor to profile some of the most prominent determinants of change and speculate as to further evolution that may consequently occur during the next decade. The five main angles to be addressed are: protein–protein interactions; peptides and peptidomimetics; molecular diversity and pharmacological space; molecular pharmacodynamics (significance, potential and challenges); and early-stage clinical efficacy and safety. We then consider, in light of these, the future of medicinal chemistry and the educational preparation that will be required for future medicinal chemists. PMID:22004084

Comparison of haematology, coagulation and clinical chemistry parameters in blood samples from the sublingual vein and vena cava in Sprague-Dawley rats.

PubMed

Seibel, J; Bodié, K; Weber, S; Bury, D; Kron, M; Blaich, G

2010-10-01

The investigation of clinical pathology parameters (haematology, clinical chemistry and coagulation) is an important part of the preclinical evaluation of drug safety. However, the blood sampling method employed should avoid or minimize stress and injury in laboratory animals. In the present study, we compared the clinical pathology results from blood samples collected terminally from the vena cava (VC) immediately before necropsy with samples taken from the sublingual vein (VS) also prior to necropsy in order to determine whether the sampling method has an influence on clinical pathology parameters. Forty-six 12-week-old male Sprague-Dawley rats were assigned to two groups (VC or VS; n = 23 each). All rats were anaesthetized with isoflurane prior to sampling. In the VC group, blood was withdrawn from the inferior VC. For VS sampling, the tongue was gently pulled out and the VS was punctured. The haematology, coagulation and clinical chemistry parameters were compared. Equivalence was established for 13 parameters, such as mean corpuscular volume, white blood cells and calcium. No equivalence was found for the remaining 26 parameters, although they were considered to be similar when compared with the historical data and normal ranges. The most conspicuous finding was that activated prothrombin time was 30.3% less in blood taken from the VC (16.6 ± 0.89 s) than that in the VS samples (23.8 ± 1.58 s). Summing up, blood sampling from the inferior VC prior to necropsy appears to be a suitable and reliable method for terminal blood sampling that reduces stress and injury to laboratory rats in preclinical drug safety studies.

Making sense of the shadows: priorities for creating a learning healthcare system based on routinely collected data

PubMed Central

Deeny, Sarah R; Steventon, Adam

2015-01-01

Socrates described a group of people chained up inside a cave, who mistook shadows of objects on a wall for reality. This allegory comes to mind when considering ‘routinely collected data’—the massive data sets, generated as part of the routine operation of the modern healthcare service. There is keen interest in routine data and the seemingly comprehensive view of healthcare they offer, and we outline a number of examples in which they were used successfully, including the Birmingham OwnHealth study, in which routine data were used with matched control groups to assess the effect of telephone health coaching on hospital utilisation. Routine data differ from data collected primarily for the purposes of research, and this means that analysts cannot assume that they provide the full or accurate clinical picture, let alone a full description of the health of the population. We show that major methodological challenges in using routine data arise from the difficulty of understanding the gap between patient and their ‘data shadow’. Strategies to overcome this challenge include more extensive data linkage, developing analytical methods and collecting more data on a routine basis, including from the patient while away from the clinic. In addition, creating a learning health system will require greater alignment between the analysis and the decisions that will be taken; between analysts and people interested in quality improvement; and between the analysis undertaken and public attitudes regarding appropriate use of data. PMID:26065466

Chemistry Rocks: Redox Chemistry as a Geologic Tool.

ERIC Educational Resources Information Center

Burns, Mary Sue

2001-01-01

Applies chemistry to earth science, uses rocks in chemistry laboratories, and teaches about transition metal chemistry, oxidation states, and oxidation-reduction reactions from firsthand experiences. (YDS)

Analytical Chemistry Laboratory Progress Report for FY 1994

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

Green, D.W.; Boparai, A.S.; Bowers, D.L.

The purpose of this report is to summarize the activities of the Analytical Chemistry Laboratory (ACL) at Argonne National Laboratory (ANL) for Fiscal Year (FY) 1994 (October 1993 through September 1994). This annual report is the eleventh for the ACL and describes continuing effort on projects, work on new projects, and contributions of the ACL staff to various programs at ANL. The Analytical Chemistry Laboratory is a full-cost-recovery service center, with the primary mission of providing a broad range of analytical chemistry support services to the scientific and engineering programs at ANL. The ACL also has a research program inmore » analytical chemistry, conducts instrumental and methods development, and provides analytical services for governmental, educational, and industrial organizations. The ACL handles a wide range of analytical problems. Some routine or standard analyses are done, but it is common for the Argonne programs to generate unique problems that require significant development of methods and adaption of techniques to obtain useful analytical data. The ACL has four technical groups -- Chemical Analysis, Instrumental Analysis, Organic Analysis, and Environmental Analysis -- which together include about 45 technical staff members. Talents and interests of staff members cross the group lines, as do many projects within the ACL. The Chemical Analysis Group uses wet- chemical and instrumental methods for elemental, compositional, and isotopic determinations in solid, liquid, and gaseous samples and provides specialized analytical services. Major instruments in this group include an ion chromatograph (IC), an inductively coupled plasma/atomic emission spectrometer (ICP/AES), spectrophotometers, mass spectrometers (including gas-analysis and thermal-ionization mass spectrometers), emission spectrographs, autotitrators, sulfur and carbon determinators, and a kinetic phosphorescence uranium analyzer.« less

A prospective, multicenter, post marketing surveillance study to evaluate the safety and effectiveness of the Superia-Sirolimus Eluting Coronary Stent System (SSECSS) implanted during routine clinical practice in India.

PubMed

Chandra, Praveen; Kumar, Tarun

2014-01-01

A prospective, multicenter, post marketing surveillance study to evaluate the safety and effectiveness of the Superia-Sirolimus Eluting Coronary Stent System (SSECSS) implanted during routine clinical practice in India. 1. To study the MACE and in stent and In-segment Loss at Six Months (in a pre selected group of 50 patients). 1. Clinical and procedural success. This is a prospective, open label, single-arm, multicenter (16 sites), post marketing observational study enrolling patients implanted with Superia-Sirolimus Eluting Coronary Stent (SSECS) in routine clinical practice in India. A total of 200 Patients of coronary Artery Disease (CAD) implanted with Superia-Sirolimus Eluting Coronary Stent (SSECS) were enrolled. Clinical assessments were done at 30 days, 180 days and at 1, 2 years either telephonically or office visit. A cohort of 50 pre-selected patients were followed up for angiographic evaluation at 180 days. MACE at 12 month of follow up was 1.71%.Late lumen loss, in segment was 0.14 and in stent was 0.10 mm at 6 month of follow-up. TLR was required only in 2 patients. Superia stent is as safe as other biodegradable polymer stent in the market and time has come for biodegradable polymer stent with thin struts. Copyright © 2014 Cardiological Society of India. Published by Elsevier B.V. All rights reserved.

Effects of introducing routinely ultrasound scanning during Ante Natal Care (ANC) clinics on number of visits of ANC and facility delivery: a cohort study.

PubMed

Mbuyita, Selemani; Tillya, Robert; Godfrey, Ritha; Kinyonge, Iddajovana; Shaban, Josephine; Mbaruku, Godfrey

2015-01-01

Many countries have integrated antenatal care as an essential part of routine maternal health services. The importance of this service cannot be overemphasized as many women's lives are usually saved particularly through early detection of pregnancy related complications. However, while many women would attend at least one visit for ante natal care (ANC), completion of recommended number of visits (4+) has been a challenge of many health systems particularly in developing countries like Tanzania. We conducted a cohort study to include ultrasound scanning using a portable hand-held Vscan to test whether by integrating it in routine ANC clinics at dispensary and health centre levels would promote number of ANC visits by women. Health providers rendering ANC services in selected facilities were trained on how to use the simple technology of ultrasound scanning. Women living in catchment areas of the respective selected facilities were eligible to inclusion to the study when consented. A baseline status of the ANC attendance in the study area was established through baseline household and facility surveys. A total of 257 women consented and received the study treatment. Our results showed that, there was no a slight change between baseline (97.2 %) and endline (97.4 %) results among women attending ANC clinics at least once. However, there was a significant change in percentage of women attending ANC clinic four times or more (27.2 % during baseline and 60.3 %; p = 0001). We conclude that, introduction of the simplified ultrasound scanning technology at lowest levels of care has an effect to improving ANC attendance in terms of number of visits and motivate facility delivery.

Is Transducer Hygiene sufficient when Vaginal Probes are used in the Clinical Routine?

PubMed

Merz, E

2016-04-01

Vaginal ultrasound probes are semi-critical Group A medical products which must be disinfected following the manufacturer's instructions after every patient examination. According to the "Essential Requirements for Medical Devices (Directive 93/42/EEC, Annex I, paragraph 13)" the manufacturer's instructions for use for reusable products must contain suitable instructions for preparation processes. This presumes both an effective and material-compatible method. Evidence of effectiveness must be validated.In the Editorial in issue 1 Ultraschall in der Medizin/European Journal of Ultrasound 2005 we discussed the topic of transducer hygiene and stated that proper handling and cleaning as well as disinfection of probes in daily use are indispensable. This applies particularly to vaginal ultrasound probes routinely used in gynecological and obstetrical clinics, gynecological practices as well as IVF centers Normally the probe used in a transvaginal ultrasound examination is covered with a latex protective cover (with CE marking) which contains a certain amount of ultrasound gel. After the examination, the cover is removed and disposed of, and the gel is removed from the transducer. Since handling of the probe, ultrasound gel and cover can result in smear infections and cross-contamination with various pathogens (e. g. MRSA, HBV, HCV, HIV, herpes papilloma and cytomegalic viruses), after the protective cover is removed, the probe must be cleaned and subjected to disinfection with a bactericidal, fungicidal and virucidal effect. This is especially important in the event the cover ruptures during the vaginal examination, and the probe comes into direct contact with vaginal secretions or blood. The same likewise applies if the sterile protective cover is perforated during a follicular puncture. Usually special bactericidal, levurocidal and virucidal wipes or special submersion disinfection methods are available for disinfecting the vaginal ultrasound probes 11. Using

Significant steps in the evolution of analytical chemistry--is the today's analytical chemistry only chemistry?

PubMed

Karayannis, Miltiades I; Efstathiou, Constantinos E

2012-12-15

In this review the history of chemistry and specifically the history and the significant steps of the evolution of analytical chemistry are presented. In chronological time spans, covering the ancient world, the middle ages, the period of the 19th century, and the three evolutional periods, from the verge of the 19th century to contemporary times, it is given information for the progress of chemistry and analytical chemistry. During this period, analytical chemistry moved gradually from its pure empirical nature to more rational scientific activities, transforming itself to an autonomous branch of chemistry and a separate discipline. It is also shown that analytical chemistry moved gradually from the status of exclusive serving the chemical science, towards serving, the environment, health, law, almost all areas of science and technology, and the overall society. Some recommendations are also directed to analytical chemistry educators concerning the indispensable nature of knowledge of classical analytical chemistry and the associated laboratory exercises and to analysts, in general, why it is important to use the chemical knowledge to make measurements on problems of everyday life. Copyright © 2012 Elsevier B.V. All rights reserved.

Incidence and severity of self-reported chemotherapy side effects in routine care: A prospective cohort study

PubMed Central

Haas, Marion; Viney, Rosalie; Pearson, Sallie-Anne; Haywood, Philip; Brown, Chris; Ward, Robyn

2017-01-01

Aim Chemotherapy side effects are often reported in clinical trials; however, there is little evidence about their incidence in routine clinical care. The objective of this study was to describe the frequency and severity of patient-reported chemotherapy side effects in routine care across treatment centres in Australia. Methods We conducted a prospective cohort study of individuals with breast, lung or colorectal cancer undergoing chemotherapy. Side effects were identified by patient self-report. The frequency, prevalence and incidence rates of side effects were calculated by cancer type and grade, and cumulative incidence curves for each side effect computed. Frequencies of side effects were compared between demographic subgroups using chi-squared statistics. Results Side effect data were available for 449 eligible individuals, who had a median follow-up of 5.64 months. 86% of participants reported at least one side effect during the study period and 27% reported a grade IV side effect, most commonly fatigue or dyspnoea. Fatigue was the most common side effect overall (85%), followed by diarrhoea (74%) and constipation (74%). Prevalence and incidence rates were similar across side effects and cancer types. Age was the only demographic factor associated with the incidence of side effects, with older people less likely to report side effects. Conclusion This research has produced the first Australian estimates of self-reported incidence of chemotherapy side effects in routine clinical care. Chemotherapy side effects in routine care are common, continue throughout chemotherapy and can be serious. This work confirms the importance of observational data in providing clinical practice-relevant information to decision-makers. PMID:29016607

Incidence and severity of self-reported chemotherapy side effects in routine care: A prospective cohort study.

PubMed

Pearce, Alison; Haas, Marion; Viney, Rosalie; Pearson, Sallie-Anne; Haywood, Philip; Brown, Chris; Ward, Robyn

2017-01-01

Chemotherapy side effects are often reported in clinical trials; however, there is little evidence about their incidence in routine clinical care. The objective of this study was to describe the frequency and severity of patient-reported chemotherapy side effects in routine care across treatment centres in Australia. We conducted a prospective cohort study of individuals with breast, lung or colorectal cancer undergoing chemotherapy. Side effects were identified by patient self-report. The frequency, prevalence and incidence rates of side effects were calculated by cancer type and grade, and cumulative incidence curves for each side effect computed. Frequencies of side effects were compared between demographic subgroups using chi-squared statistics. Side effect data were available for 449 eligible individuals, who had a median follow-up of 5.64 months. 86% of participants reported at least one side effect during the study period and 27% reported a grade IV side effect, most commonly fatigue or dyspnoea. Fatigue was the most common side effect overall (85%), followed by diarrhoea (74%) and constipation (74%). Prevalence and incidence rates were similar across side effects and cancer types. Age was the only demographic factor associated with the incidence of side effects, with older people less likely to report side effects. This research has produced the first Australian estimates of self-reported incidence of chemotherapy side effects in routine clinical care. Chemotherapy side effects in routine care are common, continue throughout chemotherapy and can be serious. This work confirms the importance of observational data in providing clinical practice-relevant information to decision-makers.

Organizational routines, innovation, and flexibility: the application of narrative networks to dynamic workflow.

PubMed

Hayes, Gillian R; Lee, Charlotte P; Dourish, Paul

2011-08-01

The purpose of this paper is to demonstrate how current visual representations of organizational and technological processes do not fully account for the variability present in everyday practices. We further demonstrate how narrative networks can augment these representations to indicate potential areas for successful or problematic adoption of new technologies and potential needs for additional training. We conducted a qualitative study of the processes and routines at a major academic medical center slated to be supported by the development and installation of a new comprehensive HIT system. We used qualitative data collection techniques including observations of the activities to be supported by the new system and interviews with department heads, researchers, and both clinical and non-clinical staff. We conducted a narrative network analysis of these data by choosing exemplar processes to be modeled, selecting and analyzing narrative fragments, and developing visual representations of the interconnection of these narratives. Narrative networks enable us to view the variety of ways work has been and can be performed in practice, influencing our ability to design for innovation in use. Narrative networks are a means for analyzing and visualizing organizational routines in concert with more traditional requirements engineering, workflow modeling, and quality improvement outcome measurement. This type of analysis can support a deeper and more nuanced understanding of how and why certain routines continue to exist, change, or stop entirely. At the same time, it can illuminate areas in which adoption may be slow, more training or communication may be needed, and routines preferred by the leadership are subverted by routines preferred by the staff. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

Increased Exposure to Rigid Routines Can Lead to Increased Challenging Behavior Following Changes to Those Routines

ERIC Educational Resources Information Center

Bull, Leah E.; Oliver, Chris; Callaghan, Eleanor; Woodcock, Kate A.

2015-01-01

Several neurodevelopmental disorders are associated with preference for routine and challenging behavior following changes to routines. We examine individuals with Prader-Willi syndrome, who show elevated levels of this behavior, to better understand how previous experience of a routine can affect challenging behavior elicited by disruption to…

The economic costs of routine INR monitoring in infants and children--examining point-of-care devices used within the home setting compared to traditional anticoagulation clinic monitoring.

PubMed

Gaw, James R; Crowley, Steven; Monagle, Paul; Jones, Sophie; Newall, Fiona

2013-07-01

The use of point-of-care (POC) devices within the home for routine INR monitoring has demonstrated reliability, safety and effectiveness in the management of infants and children requiring long-term warfarin therapy. However, a comprehensive cost-analysis of using this method of management, compared to attending anticoagulation clinics has not been reported. The aim of this study was to compare the estimated societal costs of attending anticoagulation clinics for routine INR monitoring to using a POC test in the home. This study used a comparative before-and-after design that included 60 infants and children managed via the Haematology department at a tertiary paediatric centre. Each participant was exposed to both modes of management at various times for a period of ≥3 months. A questionnaire, consisting of 25 questions was sent to families to complete and return. Data collected included: the frequency of monitoring, mode of travel to and from clinics, total time consumed, and primary carer's income level. The home monitoring cohort saved a total of 1 hour 19 minutes per INR test compared to attending anticoagulation clinics and had a cost saving to society of $66.83 (AUD) per INR test compared to traditional care; incorporating health sector costs, travel expenses and lost time. The traditional model of care requires a considerable investment of time per test from both child and carer. Home INR monitoring in infants and children provides greater societal economic benefits compared to traditional models. Copyright © 2013 Elsevier Ltd. All rights reserved.

Implementing Routine Head Circumference Measurements in Addis Ababa, Ethiopia: Means and Challenges.

PubMed

Eriksen, Arvid A; Johnsen, Joakim S; Tennøe, Anders H; Tirsit, Abenezer; Laeke, Tsegazeab; Amare, Ephrem B; Wester, Knut

2016-07-01

A substantial number of infants in Ethiopia suffer from hydrocephalus. Neurosurgical expertise has until recently been virtually nonexistent in the country; however, since 2006, a neurosurgery training program has been established in Addis Ababa, where hydrocephalus surgery now is performed in 3 hospitals. Our experience is that hydrocephalus is diagnosed and treatment is too late to avoid severe brain damage. Introducing routine head circumference (HC) measurements can ease the detection of hydrocephalus and thus lead to earlier diagnosis, thereby reducing the brain damage caused by the condition. The present pilot project had two major aims: to get the process of implementation started and to gain experience with how this implementation best can be achieved. We educated and encouraged the nurse staff members of 12 randomly selected health (mother and child) clinics in Addis Ababa in performing HC measurements, using a recently developed Ethiopian HC chart. Much of the work was related to follow-up. A local Ethiopian healthcare worker was employed to lead the follow-up and to continue the implementation in the remaining 14 clinics. During our attempted implementation of routine HC measuring, we encountered a line of administrational, cultural, infrastructural, and didactic problems and challenges, which are discussed. The experience we have gained during this pilot project will be used in further development and implementation of routine HC measuring throughout Ethiopia. These experiences may be of interest and use to others wanting to introduce similar routines in low-income countries. Copyright © 2016 Elsevier Inc. All rights reserved.

The correlation between the number of eligible patients in routine clinical practice and the low recruitment level in clinical trials: a retrospective study using electronic medical records.

PubMed

Sumi, Eriko; Teramukai, Satoshi; Yamamoto, Keiichi; Satoh, Motohiko; Yamanaka, Kenya; Yokode, Masayuki

2013-12-11

A number of clinical trials have encountered difficulties enrolling a sufficient number of patients upon initiating the trial. Recently, many screening systems that search clinical data warehouses for patients who are eligible for clinical trials have been developed. We aimed to estimate the number of eligible patients using routine electronic medical records (EMRs) and to predict the difficulty of enrolling sufficient patients prior to beginning a trial. Investigator-initiated clinical trials that were conducted at Kyoto University Hospital between July 2004 and January 2011 were included in this study. We searched the EMRs for eligible patients and calculated the eligible EMR patient index by dividing the number of eligible patients in the EMRs by the target sample size. Additionally, we divided the trial eligibility criteria into corresponding data elements in the EMRs to evaluate the completeness of mapping clinical manifestation in trial eligibility criteria into structured data elements in the EMRs. We evaluated the correlation between the index and the accrual achievement with Spearman's rank correlation coefficient. Thirteen of 19 trials did not achieve their original target sample size. Overall, 55% of the trial eligibility criteria were mapped into data elements in EMRs. The accrual achievement demonstrated a significant positive correlation with the eligible EMR patient index (r = 0.67, 95% confidence interval (CI), 0.42 to 0.92). The receiver operating characteristic analysis revealed an eligible EMR patient index cut-off value of 1.7, with a sensitivity of 69.2% and a specificity of 100.0%. Our study suggests that the eligible EMR patient index remains exploratory but could be a useful component of the feasibility study when planning a clinical trial. Establishing a step to check whether there are likely to be a sufficient number of eligible patients enables sponsors and investigators to concentrate their resources and efforts on more achievable trials.

Chalcone: A Privileged Structure in Medicinal Chemistry.

PubMed

Zhuang, Chunlin; Zhang, Wen; Sheng, Chunquan; Zhang, Wannian; Xing, Chengguo; Miao, Zhenyuan

2017-06-28

Privileged structures have been widely used as an effective template in medicinal chemistry for drug discovery. Chalcone is a common simple scaffold found in many naturally occurring compounds. Many chalcone derivatives have also been prepared due to their convenient synthesis. These natural products and synthetic compounds have shown numerous interesting biological activities with clinical potentials against various diseases. This review aims to highlight the recent evidence of chalcone as a privileged scaffold in medicinal chemistry. Multiple aspects of chalcone will be summarized herein, including the isolation of novel chalcone derivatives, the development of new synthetic methodologies, the evaluation of their biological properties, and the exploration of the mechanisms of action as well as target identification. This review is expected to be a comprehensive, authoritative, and critical review of the chalcone template to the chemistry community.

Current role of ICP-MS in clinical toxicology and forensic toxicology: a metallic profile.

PubMed

Goullé, Jean-Pierre; Saussereau, Elodie; Mahieu, Loïc; Guerbet, Michel

2014-08-01

As metal/metalloid exposure is inevitable owing to its omnipresence, it may exert toxicity in humans. Recent advances in metal/metalloid analysis have been made moving from flame atomic absorption spectrometry and electrothermal atomic absorption spectrometry to the multi-elemental inductively coupled plasma (ICP) techniques as ICP atomic emission spectrometry and ICP-MS. ICP-MS has now emerged as a major technique in inorganic analytical chemistry owing to its flexibility, high sensitivity and good reproducibility. This in depth review explores the ICP-MS metallic profile in human toxicology. It is now routinely used and of great importance, in clinical toxicology and forensic toxicology to explore biological matrices, specifically whole blood, plasma, urine, hair, nail, biopsy samples and tissues.

Pitfalls in lung cancer molecular pathology: how to limit them in routine practice?

PubMed

Ilie, M; Hofman, P

2012-01-01

New treatment options in advanced non-small cell lung carcinoma (NSCLC) targeting activating epidermal growth factor receptor (EGFR) gene mutations and other genetic alterations demonstrated the clinical significance of the molecular features of specific subsets of tumors. Therefore, the development of personalized medicine has stimulated the routine integration into pathology departments of somatic mutation testing. However, clinical mutation testing must be optimized and standardized with regard to histological profile, type of samples, pre-analytical steps, methodology and result reporting. Routine molecular testing in NSCLC is currently moving beyond EGFR mutational analysis. Recent progress of targeted therapies will require molecular testing for a wide panel of mutations for a personalized molecular diagnosis. As a consequence, efficient testing of multiple molecular abnormalities is an urgent requirement in thoracic oncology. Moreover, increasingly limited tumor sample becomes a major challenge for molecular pathology. Continuous efforts should be made for safe, effective and specific molecular analyses. This must be based on close collaboration between the departments involved in the management of lung cancer. In this review we explored the practical issues and pitfalls surrounding the routine implementation of molecular testing in NSCLC in a pathology laboratory.

Building Data-Driven Pathways From Routinely Collected Hospital Data: A Case Study on Prostate Cancer

PubMed Central

Clark, Jeremy; Cooper, Colin S; Mills, Robert; Rayward-Smith, Victor J; de la Iglesia, Beatriz

2015-01-01

Background Routinely collected data in hospitals is complex, typically heterogeneous, and scattered across multiple Hospital Information Systems (HIS). This big data, created as a byproduct of health care activities, has the potential to provide a better understanding of diseases, unearth hidden patterns, and improve services and cost. The extent and uses of such data rely on its quality, which is not consistently checked, nor fully understood. Nevertheless, using routine data for the construction of data-driven clinical pathways, describing processes and trends, is a key topic receiving increasing attention in the literature. Traditional algorithms do not cope well with unstructured processes or data, and do not produce clinically meaningful visualizations. Supporting systems that provide additional information, context, and quality assurance inspection are needed. Objective The objective of the study is to explore how routine hospital data can be used to develop data-driven pathways that describe the journeys that patients take through care, and their potential uses in biomedical research; it proposes a framework for the construction, quality assessment, and visualization of patient pathways for clinical studies and decision support using a case study on prostate cancer. Methods Data pertaining to prostate cancer patients were extracted from a large UK hospital from eight different HIS, validated, and complemented with information from the local cancer registry. Data-driven pathways were built for each of the 1904 patients and an expert knowledge base, containing rules on the prostate cancer biomarker, was used to assess the completeness and utility of the pathways for a specific clinical study. Software components were built to provide meaningful visualizations for the constructed pathways. Results The proposed framework and pathway formalism enable the summarization, visualization, and querying of complex patient-centric clinical information, as well as the

Safety and efficacy of long-term use of sodium oxybate for narcolepsy with cataplexy in routine clinical practice.

PubMed

Drakatos, Panagis; Lykouras, Dimosthenis; D'Ancona, Grainne; Higgins, Sean; Gildeh, Nadia; Macavei, Raluca; Rosenzweig, Ivana; Steier, Joerg; Williams, Adrian J; Muza, Rexford; Kent, Brian D; Leschziner, Guy

2017-07-01

Sodium oxybate is licensed in Europe for the treatment of narcolepsy with cataplexy in adults. The aim of this study was to assess the efficacy and safety of sodium oxybate in clinical practice in patients with narcolepsy and cataplexy refractory to other treatments. This was a retrospective single centre study including patients with severe narcolepsy with cataplexy refractory to other treatments, who were initiated on sodium oxybate between 2009 and 2015. Patients were allowed to be on other stimulants or/and anti-cataplectic agents. Epworth sleepiness scale (ESS) and weekly cataplexy events were recorded. Side effects (SEs) were recorded at every follow-up visit. 90 patients were prescribed sodium oxybate, with a total of 3116 patient-months of drug exposure. ESS and weekly cataplexy events were significantly reduced by sodium oxybate for all patients (ΔESS = 4.3 ± 4.4 and Δcataplexy = 21.8 ± 18.5 events/week; p < 0.0001, respectively). The required maintenance dose could not be predicted based upon gender, body mass index, or clinical factors. 60% of patients were able to reduce or come off other medications. Half of the patients experienced at least one SE, and 26.6% had to stop treatment due to limiting SEs. Nausea, mood swings and enuresis were the most commonly reported SEs. SEs that led to drug discontinuation, particularly psychosis, were associated with increasing age and were observed early after the initiation of the drug. Sodium oxybate provides a good clinical efficacy and acceptable safety profile in routine clinical practice for the treatment of patients suffering from narcolepsy with cataplexy. A quarter of patients experience SEs requiring withdrawal of the drug with older patients being more vulnerable to the more serious SEs. Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved.

Ethical aspects of clinical chemistry.

PubMed Central

BenGershôm, E

1983-01-01

The work performed by the clinical chemist may deeply affect the decisions of the doctor and the well-being of the patient. Yet in contrast to the doctor and to the nurse the clinical chemist usually has no personal relationship with the patient. Being encumbered by much technology and anonymity is itself a reason for scrutinising his involvement in issues of health care ethics. This is an attempt at clarifying some major aspects: the relationship of his professional ethics to medical ethics as a whole, his ethical obligations to the patient and to society, and other aspects. PMID:6199500

Estimation of the effects of multipoint pacing on battery longevity in routine clinical practice.

PubMed

Akerström, Finn; Narváez, Irene; Puchol, Alberto; Pachón, Marta; Martín-Sierra, Cristina; Rodríguez-Mañero, Moisés; Rodríguez-Padial, Luis; Arias, Miguel A

2017-09-23

Multipoint pacing (MPP) permits simultaneous multisite pacing of the left ventricle (LV); initial studies suggest haemodynamic and clinical benefits over conventional (single LV site) cardiac resynchronization therapy (CRT). The aim of this study was to estimate the impact of MPP activation on battery longevity in routine clinical practice. Patient (n = 46) and device data were collected from two centres at least 3 months after MPP-CRT device implantation. Multipoint pacing programming was based on the maximal possible anatomical LV1/LV2 separation according to three predefined LV pacing capture threshold (PCT) cut-offs (≤1.5 V; ≤4.0 V; and ≤6.5 V). Estimated battery longevity was calculated using the programmed lower rate limit, lead impedances, outputs, and pacing percentages. Relative to the longevity for conventional CRT using the lowest PCT (8.9 ± 1.2 years), MPP activation significantly shortened battery longevity for all three PCT cut-offs (≤1.5 V, -5.6%; ≤4.0 V, -16.9%; ≤6.5 V, -21.3%; P's <0.001). When compared with conventional CRT based on longest right ventricle-LV delay (8.3 ± 1.3 years), battery longevity was significantly shortened for the MPP ≤ 4.0 V and ≤6.5 V cut-offs (-10.8 and -15.7%, respectively; P's <0.001). Maximal LV1/LV2 spacing was possible in 23.9% (≤1.5 V), 56.5% (≤4.0 V), and 69.6% (≤6.5 V) of patients. Multipoint pacing activation significantly reduces battery longevity compared with that for conventional CRT configuration. When reasonable MPP LV vector PCTs (≤4.0 V) are achieved, the decrease in battery longevity is relatively small which may prompt the clinician to activate MPP. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2017. For permissions, please email: journals.permissions@oup.com.

RADIATION CHEMISTRY 2010 GORDON RESEARCH CONFERENCE JULY 18-23

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

Thomas Orlando

The 2010 Gordon Conference on Radiation Chemistry will present cutting edge research regarding the study of radiation-induced chemical transformations. Radiation Chemistry or 'high energy' chemistry is primarily initiated by ionizing radiation: i.e. photons or particles with energy sufficient to create conduction band electrons and 'holes', excitons, ionic and neutral free radicals, highly excited states, and solvated electrons. These transients often interact or 'react' to form products vastly different than those produced under thermal equilibrium conditions. The non-equilibrium, non-thermal conditions driving radiation chemistry exist in plasmas, star-forming regions, the outer solar system, nuclear reactors, nuclear waste repositories, radiation-based medical/clinical treatment centersmore » and in radiation/materials processing facilities. The 2010 conference has a strong interdisciplinary flavor with focus areas spanning (1) the fundamental physics and chemistry involved in ultrafast (atto/femtosecond) energy deposition events, (2) radiation-induced processes in biology (particularly spatially resolved studies), (3) radiation-induced modification of materials at the nanoscale and cosmic ray/x-ray mediated processes in planetary science/astrochemistry. While the conference concentrates on fundamental science, topical applied areas covered will also include nuclear power, materials/polymer processing, and clinical/radiation treatment in medicine. The Conference will bring together investigators at the forefront of their field, and will provide opportunities for junior scientists and graduate students to present work in poster format or as contributors to the Young Investigator session. The program and format provides excellent avenues to promote cross-disciplinary collaborations.« less

Potential use of routine databases in health technology assessment.

PubMed

Raftery, J; Roderick, P; Stevens, A

2005-05-01

To develop criteria for classifying databases in relation to their potential use in health technology (HT) assessment and to apply them to a list of databases of relevance in the UK. To explore the extent to which prioritized databases could pick up those HTs being assessed by the National Coordinating Centre for Health Technology Assessment (NCCHTA) and the extent to which these databases have been used in HT assessment. To explore the validation of the databases and their cost. Electronic databases. Key literature sources. Experienced users of routine databases. A 'first principles' examination of the data necessary for each type of HT assessment was carried out, supplemented by literature searches and a historical review. The principal investigators applied the criteria to the databases. Comments of the 'keepers' of the prioritized databases were incorporated. Details of 161 topics funded by the NHS R&D Health Technology Assessment (HTA) programme were reviewed iteratively by the principal investigators. Uses of databases in HTAs were identified by literature searches, which included the title of each prioritized database as a keyword. Annual reports of databases were examined and 'keepers' queried. The validity of each database was assessed using criteria based on a literature search and involvement by the authors in a national academic network. The costs of databases were established from annual reports, enquiries to 'keepers' of databases and 'guesstimates' based on cost per record. For assessing effectiveness, equity and diffusion, routine databases were classified into three broad groups: (1) group I databases, identifying both HTs and health states, (2) group II databases, identifying the HTs, but not a health state, and (3) group III databases, identifying health states, but not an HT. Group I datasets were disaggregated into clinical registries, clinical administrative databases and population-oriented databases. Group III were disaggregated into adverse

Effectiveness of core stabilization exercises and routine exercise therapy in management of pain in chronic non-specific low back pain: A randomized controlled clinical trial.

PubMed

Akhtar, Muhammad Waseem; Karimi, Hossein; Gilani, Syed Amir

2017-01-01

Low back pain is a frequent problem faced by the majority of people at some point in their lifetime. Exercise therapy has been advocated an effective treatment for chronic low back pain. However, there is lack of consensus on the best exercise treatment and numerous studies are underway. Conclusive studies are lacking especially in this part of the world. Thisstudy was designed to compare the effectiveness of specific stabilization exercises with routine physical therapy exerciseprovided in patients with nonspecific chronic mechanical low back pain. This is single blinded randomized control trial that was conducted at the department of physical therapy Orthopedic and Spine Institute, Johar Town, Lahore in which 120 subjects with nonspecific chronic low back pain participated. Subjects with the age between 20 to 60 years and primary complaint of chronic low back pain were recruited after giving an informed consent. Participants were randomly assigned to two treatment groups A & B which were treated with core stabilization exercise and routine physical therapy exercise respectively. TENS and ultrasound were given as therapeutic modalities to both treatment groups. Outcomes of the treatment were recorded using Visual Analogue Scale (VAS) pretreatment, at 2 nd , 4 th and 6 th week post treatment. The results of this study illustrate that clinical and therapeutic effects of core stabilization exercise program over the period of six weeks are more effective in terms of reduction in pain, compared to routine physical therapy exercise for similar duration. This study found significant reduction in pain across the two groups at 2 nd , 4 th and 6 th week of treatment with p value less than 0.05. There was a mean reduction of 3.08 and 1.71 on VAS across the core stabilization group and routine physical therapy exercise group respectively. Core stabilization exercise is more effective than routine physical therapy exercise in terms of greater reduction in pain in patients with

Effect of Food, Diet and Nutrition on Military Readiness and Preparedness of Army Personnel and Dependents in a Peacetime Environment

DTIC Science & Technology

1991-08-15

Beckman Synchron CX5 automated clinical chemistry system; b. Coulter STKS automated hematology system with five part differential; c. Perkin Elmer P1000...500,000 of Pennington center funds were used to equip this laboratory. Progress on Method Development a. General Chemistry Most routine chemistry analyses...are performed on the Beckman Synchron CX5 automated chemistry system. A description of this system is given in the Second Annual Report, pg 8 (1

Application and evaluation of interactive 3D PDF for presenting and sharing planning results for liver surgery in clinical routine.

PubMed

Newe, Axel; Becker, Linda; Schenk, Andrea

2014-01-01

The Portable Document Format (PDF) is the de-facto standard for the exchange of electronic documents. It is platform-independent, suitable for the exchange of medical data, and allows for the embedding of three-dimensional (3D) surface mesh models. In this article, we present the first clinical routine application of interactive 3D surface mesh models which have been integrated into PDF files for the presentation and the exchange of Computer Assisted Surgery Planning (CASP) results in liver surgery. We aimed to prove the feasibility of applying 3D PDF in medical reporting and investigated the user experience with this new technology. We developed an interactive 3D PDF report document format and implemented a software tool to create these reports automatically. After more than 1000 liver CASP cases that have been reported in clinical routine using our 3D PDF report, an international user survey was carried out online to evaluate the user experience. Our solution enables the user to interactively explore the anatomical configuration and to have different analyses and various resection proposals displayed within a 3D PDF document covering only a single page that acts more like a software application than like a typical PDF file ("PDF App"). The new 3D PDF report offers many advantages over the previous solutions. According to the results of the online survey, the users have assessed the pragmatic quality (functionality, usability, perspicuity, efficiency) as well as the hedonic quality (attractiveness, novelty) very positively. The usage of 3D PDF for reporting and sharing CASP results is feasible and well accepted by the target audience. Using interactive PDF with embedded 3D models is an enabler for presenting and exchanging complex medical information in an easy and platform-independent way. Medical staff as well as patients can benefit from the possibilities provided by 3D PDF. Our results open the door for a wider use of this new technology, since the basic idea

HIV Prevention Counseling Intervention Delivered During Routine Clinical Care Reduces HIV Risk Behavior in HIV-Infected South Africans Receiving Antiretroviral Therapy: The Izindlela Zokuphila/Options for Health Randomized Trial

PubMed Central

Fisher, Jeffrey D.; Cornman, Deborah H.; Shuper, Paul A.; Christie, Sarah; Pillay, Sandy; Macdonald, Susan; Ngcobo, Ntombenhle; Amico, K. Rivet; Lalloo, Umesh; Friedland, Gerald; Fisher, William A.

2014-01-01

Context Sustainable interventions are needed to minimize HIV risk behavior among people living with HIV (PLWH) in South Africa on antiretroviral therapy (ART), a significant proportion of whom do not achieve viral suppression. Objective To determine whether a brief lay counselor delivered intervention implemented during routine care can reduce risky sex among PLWH on ART. Design Cluster randomized 16 HIV clinical care sites in KwaZulu Natal, South Africa, to intervention or standard-of-care. Setting Publicly funded HIV clinical care sites. Patients 1891 PLWH on ART received the HIV prevention counseling intervention (n = 967) or standard-of-care counseling (n = 924). Intervention Lay counselors delivered a brief intervention using motivational interviewing strategies based on the Information—Motivation—Behavioral Skills (IMB) model during routine clinical care. Main Outcome Measures Number of sexual events without a condom in the past four weeks with partners of any HIV status, and with partners perceived to be HIV-negative or HIV-status unknown, assessed at baseline, 6, 12, and 18 months. Results Intervention participants reported significantly greater reductions in HIV risk behavior on both primary outcomes, compared to standard-of-care participants. Differences in STI incidence between arms were not observed. Conclusion Effective behavioral interventions, delivered by lay counselors within the clinical care setting, are consistent with the strategy of linking HIV care and HIV prevention and integrating biomedical and behavioral approaches to stemming the HIV epidemic. PMID:25230288

Atomdroid: a computational chemistry tool for mobile platforms.

PubMed

Feldt, Jonas; Mata, Ricardo A; Dieterich, Johannes M

2012-04-23

We present the implementation of a new molecular mechanics program designed for use in mobile platforms, the first specifically built for these devices. The software is designed to run on Android operating systems and is compatible with several modern tablet-PCs and smartphones available in the market. It includes molecular viewer/builder capabilities with integrated routines for geometry optimizations and Monte Carlo simulations. These functionalities allow it to work as a stand-alone tool. We discuss some particular development aspects, as well as the overall feasibility of using computational chemistry software packages in mobile platforms. Benchmark calculations show that through efficient implementation techniques even hand-held devices can be used to simulate midsized systems using force fields.

Children's Daily Routines during Kindergarten Transition

ERIC Educational Resources Information Center

Wildenger, Leah K.; McIntyre, Laura Lee; Fiese, Barbara H.; Eckert, Tanya L.

2008-01-01

Routines are an important feature of family life and functioning in families with young children. Common daily routines such as dinnertime, bedtime, and waking activities are powerful organizers of family behavior and may be instrumental to children and families during times of transition, such as elementary school entry. Daily routines were…

Evolutionary Dynamics of Digitized Organizational Routines

ERIC Educational Resources Information Center

Liu, Peng

2013-01-01

This dissertation explores the effects of increased digitization on the evolutionary dynamics of organizational routines. Do routines become more flexible, or more rigid, as the mix of digital technologies and human actors changes? What are the mechanisms that govern the evolution of routines? The dissertation theorizes about the effects of…

Estimating clinical chemistry reference values based on an existing data set of unselected animals.

PubMed

Dimauro, Corrado; Bonelli, Piero; Nicolussi, Paola; Rassu, Salvatore P G; Cappio-Borlino, Aldo; Pulina, Giuseppe

2008-11-01

In an attempt to standardise the determination of biological reference values, the International Federation of Clinical Chemistry (IFCC) has published a series of recommendations on developing reference intervals. The IFCC recommends the use of an a priori sampling of at least 120 healthy individuals. However, such a high number of samples and laboratory analysis is expensive, time-consuming and not always feasible, especially in veterinary medicine. In this paper, an alternative (a posteriori) method is described and is used to determine reference intervals for biochemical parameters of farm animals using an existing laboratory data set. The method used was based on the detection and removal of outliers to obtain a large sample of animals likely to be healthy from the existing data set. This allowed the estimation of reliable reference intervals for biochemical parameters in Sarda dairy sheep. This method may also be useful for the determination of reference intervals for different species, ages and gender.

How do family physicians measure blood pressure in routine clinical practice?

PubMed Central

Kaczorowski, Janusz; Myers, Martin G.; Gelfer, Mark; Dawes, Martin; Mang, Eric J.; Berg, Angelique; Grande, Claudio Del; Kljujic, Dragan

2017-01-01

Abstract Objective To describe the techniques currently used by family physicians in Canada to measure blood pressure (BP) for screening for, diagnosing, and treating hypertension. Design A Web-based cross-sectional survey distributed by e-mail. Setting Stratified random sample of family physicians in Canada. Participants Family physician members of the College of Family Physicians of Canada with valid e-mail addresses. Main outcome measures Physicians’ self-reported routine methods for recording BP in their practices to screen for, diagnose, and manage hypertension. Results A total of 774 valid responses were received, for a response rate of 16.2%. Respondents were similar to nonrespondents except for underrepresentation of male physicians. Of 769 respondents, 417 (54.2%) indicated that they used manual office BP measurement with a mercury or aneroid device and stethoscope as the routine method to screen patients for high BP, while 42.9% (330 of 769) reported using automated office BP (AOBP) measurement. The method most frequently used to make a diagnosis of hypertension was AOBP measurement (31.1%, 240 of 771), followed by home BP measurement (22.4%, 173 of 771) and manual office BP measurement (21.4%, 165 of 771). Ambulatory BP monitoring (ABPM) was used for diagnosis by 14.4% (111 of 771) of respondents. The most frequently reported method for ongoing management was home BP monitoring (68.7%, 528 of 769), followed by manual office BP measurement (63.6%, 489 of 769) and AOBP measurement (59.2%, 455 of 769). More than three-quarters (77.8%, 598 of 769) of respondents indicated that ABPM was readily available for their patients. Conclusion Canadian family physicians exhibit overall high use of electronic devices for BP measurement, However, more efforts are needed to encourage practitioners to follow current Canadian guidelines, which advocate the use of AOBP measurement for hypertension screening, ABPM and home BP measurement for making a diagnosis, and both

Forensic Chemistry

NASA Astrophysics Data System (ADS)

Bell, Suzanne

2009-07-01

Forensic chemistry is unique among chemical sciences in that its research, practice, and presentation must meet the needs of both the scientific and the legal communities. As such, forensic chemistry research is applied and derivative by nature and design, and it emphasizes metrology (the science of measurement) and validation. Forensic chemistry has moved away from its analytical roots and is incorporating a broader spectrum of chemical sciences. Existing forensic practices are being revisited as the purview of forensic chemistry extends outward from drug analysis and toxicology into such diverse areas as combustion chemistry, materials science, and pattern evidence.

Routine vs extended outpatient EEG for the detection of interictal epileptiform discharges

PubMed Central

Britton, Jeffrey W.; Rajasekaran, Vijayalakshmi; Fabris, Rachel R.; Cherian, Perumpillichira J.; Kelly-Williams, Kristen M.; So, Elson L.; Nickels, Katherine C.; Wong-Kisiel, Lily C.; Lagerlund, Terrence D.; Cascino, Gregory D.; Worrell, Gregory A.; Wirrell, Elaine C.

2016-01-01

Objective: To compare the yield of epileptiform abnormalities on 30-minute recordings with those greater than 45 minutes. Methods: We performed a prospective observational cross-sectional study of all outpatient routine EEGs comparing the rate of interictal epileptiform discharges (IEDs) and clinical events during the initial 30 minutes (routine) with those occurring in the remaining 30–60 minutes (extended). A relative increase of 10% was considered clinically significant. Results: EEGs from 1,803 patients were included; overall EEG duration was 59.4 minutes (SD ±6.5). Of 426 patients with IEDs at any time during the EEG, 81 (19.1%, 95% confidence interval 15.6–23) occurred only after the initial 30 minutes. The rate of late IEDs was not associated with age, indication, IED type, or sleep deprivation. Longer recording times also increased event capture rate by approximately 30%. Conclusions: The yield of IED and event detection is increased in extended outpatient EEGs compared to 30-minute studies. PMID:26984946

Routine vs extended outpatient EEG for the detection of interictal epileptiform discharges.

PubMed

Burkholder, David B; Britton, Jeffrey W; Rajasekaran, Vijayalakshmi; Fabris, Rachel R; Cherian, Perumpillichira J; Kelly-Williams, Kristen M; So, Elson L; Nickels, Katherine C; Wong-Kisiel, Lily C; Lagerlund, Terrence D; Cascino, Gregory D; Worrell, Gregory A; Wirrell, Elaine C

2016-04-19

To compare the yield of epileptiform abnormalities on 30-minute recordings with those greater than 45 minutes. We performed a prospective observational cross-sectional study of all outpatient routine EEGs comparing the rate of interictal epileptiform discharges (IEDs) and clinical events during the initial 30 minutes (routine) with those occurring in the remaining 30-60 minutes (extended). A relative increase of 10% was considered clinically significant. EEGs from 1,803 patients were included; overall EEG duration was 59.4 minutes (SD ±6.5). Of 426 patients with IEDs at any time during the EEG, 81 (19.1%, 95% confidence interval 15.6-23) occurred only after the initial 30 minutes. The rate of late IEDs was not associated with age, indication, IED type, or sleep deprivation. Longer recording times also increased event capture rate by approximately 30%. The yield of IED and event detection is increased in extended outpatient EEGs compared to 30-minute studies. © 2016 American Academy of Neurology.

[Onyx embolization for treatment of dural arteriovenous fistula: comparison of long- distance versus routine injection method].

PubMed

He, Xiao-Yan; Zhang, Guo-Zhong; Li, Ming-Zhou; Wang, Gang; Liu, Dan; Qi, Song-Tao; Li, Wei-Guang; Feng, Wen-Feng

2016-03-01

To compare the efficacy, clinical characteristics, safety, injection time and radiation exposure of Onyx embolization using a long-distance injection method and routine injection method for management of dural arteriovenous fistula (DAVF). The clinical data were retrospectively analyzed in 59 patients with DAVF treated with Onyx embolization using long-distance injection method (28 patients) and routine injection method (31 patients). The efficacy, safety, injection time and radiation exposure during Onyx embolization were compared between the two injections methods. The average radiation dose exposure to the surgeon per procedure was significantly lower in the long-distance injection group than in the routine group. The injection time (P=0.53), injection volume (P=0.78), number of supply arteries (P=0.80), Cognard types (P=0.67), and effect of embolization (P=0.88) were all similar between the two groups. Endovaseular treatment of intracranial DAVF with Onyx embolization using the long-distance injection method is feasible, safe and effective and can reduce the radiation exposure to the surgeon.

Differences in Routine Laboratory Ordering Between a Teaching Service and a Hospitalist Service at a Single Academic Medical Center.

PubMed

Ellenbogen, Michael I; Ma, Madeleine; Christensen, Nicholas P; Lee, Jungwha; O'Leary, Kevin J

2017-01-01

Studies have shown that the overutilization of laboratory tests ("labs") for hospitalized patients is common and can cause adverse health outcomes. Our objective was to compare the ordering tendencies for routine complete blood counts (CBC) and chemistry panels by internal medicine residents and hospitalists. This observational study included a survey of medicine residents and hospitalists and a retrospective analysis of labs ordering data. The retrospective data analysis comprised patients admitted to either the teaching service or nonteaching hospitalist service at a single hospital during 2014. The survey asked residents and hospitalists about their practices and preferences on labs ordering. The frequency and timing of one-time and daily CBC and basic chemistry panel ordering for teaching service and hospitalist patients were obtained from our data warehouse. The average number of CBCs per patient per day and chemistry panels per patient per day was calculated for both services and multivariate regression was performed to control for patient characteristics. Forty-four of 120 (37%) residents and 41 of 53 (77%) hospitalists responded to the survey. Forty-four (100%) residents reported ordering a daily CBC and chemistry panel rather than one-time labs at patient admission compared with 22 (54%) hospitalists ( P < 0.001). For CBCs, teaching service patients averaged 1.72/day and hospitalist service patients averaged 1.43/day ( P < 0.001). For basic chemistry panels, teaching service patients averaged 1.96/day and hospitalist service patients averaged 1.78/day ( P < 0.001). Results were similar in multivariate regression models adjusting for patient characteristics. Residents' self-reported and actual use of CBCs and chemistry panels is significantly higher than that of hospitalists in the same hospital. Our results reveal an opportunity for greater supervision and improved instruction of cost-conscious ordering practices.