Understanding the cluster randomised crossover design: a graphical illustraton of the components of variation and a sample size tutorial.

PubMed

Arnup, Sarah J; McKenzie, Joanne E; Hemming, Karla; Pilcher, David; Forbes, Andrew B

2017-08-15

In a cluster randomised crossover (CRXO) design, a sequence of interventions is assigned to a group, or 'cluster' of individuals. Each cluster receives each intervention in a separate period of time, forming 'cluster-periods'. Sample size calculations for CRXO trials need to account for both the cluster randomisation and crossover aspects of the design. Formulae are available for the two-period, two-intervention, cross-sectional CRXO design, however implementation of these formulae is known to be suboptimal. The aims of this tutorial are to illustrate the intuition behind the design; and provide guidance on performing sample size calculations. Graphical illustrations are used to describe the effect of the cluster randomisation and crossover aspects of the design on the correlation between individual responses in a CRXO trial. Sample size calculations for binary and continuous outcomes are illustrated using parameters estimated from the Australia and New Zealand Intensive Care Society - Adult Patient Database (ANZICS-APD) for patient mortality and length(s) of stay (LOS). The similarity between individual responses in a CRXO trial can be understood in terms of three components of variation: variation in cluster mean response; variation in the cluster-period mean response; and variation between individual responses within a cluster-period; or equivalently in terms of the correlation between individual responses in the same cluster-period (within-cluster within-period correlation, WPC), and between individual responses in the same cluster, but in different periods (within-cluster between-period correlation, BPC). The BPC lies between zero and the WPC. When the WPC and BPC are equal the precision gained by crossover aspect of the CRXO design equals the precision lost by cluster randomisation. When the BPC is zero there is no advantage in a CRXO over a parallel-group cluster randomised trial. Sample size calculations illustrate that small changes in the specification of the WPC or BPC can increase the required number of clusters. By illustrating how the parameters required for sample size calculations arise from the CRXO design and by providing guidance on both how to choose values for the parameters and perform the sample size calculations, the implementation of the sample size formulae for CRXO trials may improve.

Quality of Reporting Nutritional Randomized Controlled Trials in Patients With Cystic Fibrosis.

PubMed

Daitch, Vered; Babich, Tanya; Singer, Pierre; Leibovici, Leonard

2016-08-01

Randomized controlled trials (RCTs) have a major role in the making of evidence-based guidelines. The aim of the present study was to critically appraise the RCTs that addressed nutritional interventions in patients with cystic fibrosis. Embase, PubMed, and the Cochrane Library were systematically searched until July 2015. Methodology and reporting of nutritional RCTs were evaluated by the Consolidated Standards of Reporting Trials (CONSORT) checklist and additional dimensions relevant to patients with CF. Fifty-one RCTs were included. Full details on methods were provided in a minority of studies. The mean duration of intervention was <6 months. 56.9% of the RCTs did not define a primary outcome; 70.6% of studies did not provide details on sample size calculation; and only 31.4% reported on the subgroup or separated between important subgroups. The examined RCTs were characterized by a weak methodology, a small number of patients with no sample size calculations, a relatively short intervention, and many times did not examine the outcomes that are important to the patient. Improvement over the years has been minor.

Confirmatory factor analysis and recommendations for improvement of the Autonomy-Preference-Index (API).

PubMed

Simon, Daniela; Kriston, Levente; Loh, Andreas; Spies, Claudia; Scheibler, Fueloep; Wills, Celia; Härter, Martin

2010-09-01

Validation of the German version of the Autonomy-Preference-Index (API), a measure of patients' preferences for decision making and information seeking. Stepwise confirmatory factor analysis was conducted on a sample of patients (n = 1592) treated in primary care for depression (n = 186), surgical and internal medicine inpatients (n = 811) and patients with minor trauma treated in an emergency department (n = 595). An initial test of the model was done on calculation and validation halves of the sample. Both local and global indexes-of-fit suggested modifications to the scale. The scale was modified and re-tested in the calculation sample and confirmed in the validation sample. Subgroup analyses for age, gender and type of treatment setting were also performed. The confirmatory analysis led to a modified version of the API with better local and global indexes-of-fit for samples of German-speaking patients. Two items of the sub-scale, 'preference for decision-making', and one item of the sub-scale, 'preference for information seeking', showed very low reliability scores and were deleted. Thus, several global indexes-of-fit clearly improved significantly. The modified scale was confirmed on the validation sample with acceptable to good indices of fit. Results of subgroup analyses indicated that no adaptations were necessary. This first confirmatory analysis for a German-speaking population showed that the API was improved by the removal of several items. There were theoretically plausible explanations for this improvement suggesting that the modifications might also be appropriate in English and other language versions.

Short-term glucagon stimulation test of C-peptide effect on glucose utilization in patients with type 1 diabetes mellitus.

PubMed

Mojto, Viliam; Rausova, Zuzana; Chrenova, Jana; Dedik, Ladislav

2015-12-01

This work aimed to evaluate the use of a four-point glucagon stimulation test of C-peptide effect on glucose utilization in type 1 diabetic patients using a new mathematical model. A group of 32 type 1 diabetic patients and a group of 10 healthy control subjects underwent a four-point glucagon stimulation test with blood sampling at 0, 6, 15 and 30 min after 1 mg glucagon bolus intravenous administration. Pharmacokinetic and pharmacokinetic/pharmacodynamic models of C-peptide effect on glucose utilization versus area under curve (AUC) were used. A two-sample t test and ANOVA with Bonferroni correction were used to test the significance of differences between parameters. A significant difference between control and patient groups regarding the coefficient of whole-body glucose utilization and AUC C-peptide/AUC glucose ratio (p ≪ 0.001 and p = 0.002, respectively) was observed. The high correlation (r = 0.97) between modeled coefficient of whole-body glucose utilization and numerically calculated AUC C-peptide/AUC glucose ratio related to entire cohort indicated the stability of used method. The short-term four-point glucagon stimulation test allows the numerically calculated AUC C-peptide/AUC glucose ratio and/or the coefficient of whole-body glucose utilization calculated from model to be used to diagnostically identify type 1 diabetic patients.

Applying Ancestry and Sex Computation as a Quality Control Tool in Targeted Next-Generation Sequencing.

PubMed

Mathias, Patrick C; Turner, Emily H; Scroggins, Sheena M; Salipante, Stephen J; Hoffman, Noah G; Pritchard, Colin C; Shirts, Brian H

2016-03-01

To apply techniques for ancestry and sex computation from next-generation sequencing (NGS) data as an approach to confirm sample identity and detect sample processing errors. We combined a principal component analysis method with k-nearest neighbors classification to compute the ancestry of patients undergoing NGS testing. By combining this calculation with X chromosome copy number data, we determined the sex and ancestry of patients for comparison with self-report. We also modeled the sensitivity of this technique in detecting sample processing errors. We applied this technique to 859 patient samples with reliable self-report data. Our k-nearest neighbors ancestry screen had an accuracy of 98.7% for patients reporting a single ancestry. Visual inspection of principal component plots was consistent with self-report in 99.6% of single-ancestry and mixed-ancestry patients. Our model demonstrates that approximately two-thirds of potential sample swaps could be detected in our patient population using this technique. Patient ancestry can be estimated from NGS data incidentally sequenced in targeted panels, enabling an inexpensive quality control method when coupled with patient self-report. © American Society for Clinical Pathology, 2016. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Impact of Different Creatinine Measurement Methods on Liver Transplant Allocation

PubMed Central

Kaiser, Thorsten; Kinny-Köster, Benedict; Bartels, Michael; Parthaune, Tanja; Schmidt, Michael; Thiery, Joachim

2014-01-01

Introduction The model for end-stage liver disease (MELD) score is used in many countries to prioritize organ allocation for the majority of patients who require orthotopic liver transplantation. This score is calculated based on the following laboratory parameters: creatinine, bilirubin and the international normalized ratio (INR). Consequently, high measurement accuracy is essential for equitable and fair organ allocation. For serum creatinine measurements, the Jaffé method and enzymatic detection are well-established routine diagnostic tests. Methods A total of 1,013 samples from 445 patients on the waiting list or in evaluation for liver transplantation were measured using both creatinine methods from November 2012 to September 2013 at the university hospital Leipzig, Germany. The measurements were performed in parallel according to the manufacturer’s instructions after the samples arrived at the institute of laboratory medicine. Patients who had required renal replacement therapy twice in the previous week were excluded from analyses. Results Despite the good correlation between the results of both creatinine quantification methods, relevant differences were observed, which led to different MELD scores. The Jaffé measurement led to greater MELD score in 163/1,013 (16.1%) samples with differences of up to 4 points in one patient, whereas differences of up to 2 points were identified in 15/1,013 (1.5%) samples using the enzymatic assay. Overall, 50/152 (32.9%) patients with MELD scores >20 had higher scores when the Jaffé method was used. Discussion Using the Jaffé method to measure creatinine levels in samples from patients who require liver transplantation may lead to a systematic preference in organ allocation. In this study, the differences were particularly pronounced in samples with MELD scores >20, which has clinical relevance in the context of urgency of transplantation. These data suggest that official recommendations are needed to determine which laboratory diagnostic methods should be used when calculating MELD scores. PMID:24587188

Statistical power calculations for mixed pharmacokinetic study designs using a population approach.

PubMed

Kloprogge, Frank; Simpson, Julie A; Day, Nicholas P J; White, Nicholas J; Tarning, Joel

2014-09-01

Simultaneous modelling of dense and sparse pharmacokinetic data is possible with a population approach. To determine the number of individuals required to detect the effect of a covariate, simulation-based power calculation methodologies can be employed. The Monte Carlo Mapped Power method (a simulation-based power calculation methodology using the likelihood ratio test) was extended in the current study to perform sample size calculations for mixed pharmacokinetic studies (i.e. both sparse and dense data collection). A workflow guiding an easy and straightforward pharmacokinetic study design, considering also the cost-effectiveness of alternative study designs, was used in this analysis. Initially, data were simulated for a hypothetical drug and then for the anti-malarial drug, dihydroartemisinin. Two datasets (sampling design A: dense; sampling design B: sparse) were simulated using a pharmacokinetic model that included a binary covariate effect and subsequently re-estimated using (1) the same model and (2) a model not including the covariate effect in NONMEM 7.2. Power calculations were performed for varying numbers of patients with sampling designs A and B. Study designs with statistical power >80% were selected and further evaluated for cost-effectiveness. The simulation studies of the hypothetical drug and the anti-malarial drug dihydroartemisinin demonstrated that the simulation-based power calculation methodology, based on the Monte Carlo Mapped Power method, can be utilised to evaluate and determine the sample size of mixed (part sparsely and part densely sampled) study designs. The developed method can contribute to the design of robust and efficient pharmacokinetic studies.

A comparison of perceived and calculated weight status classification congruence between pre- and post-bariatric surgery patients.

PubMed

Ferriby, Megan; Pratt, Keeley; Noria, Sabrena; Needleman, Bradley

2017-08-01

One prominent reason patients undergo bariatric surgery is to reduce their excess weight and body mass index. Weight status classifications (WSCs), based on calculated body mass index, organize patients into distinct groups (underweight, healthy weight, overweight, class I obesity, class II obesity, and class III obesity) for treatment recommendations, including surgery for patients with obesity. Bariatric patients' perceptions of their WSC is important to consider, because patients who accurately perceive their WSC presurgery have greater motivation for health behavior changes; alternatively, incongruence between perceived and calculated WSC could deter motivation and ultimately their health changes postsurgery. This study seeks to understand the congruence between patients' perceived and calculated WSC, and to determine if there are differences in congruence between groups of pre- or postsurgery, male and female, and emerging/early adulthood and middle/late adulthood patients. University Hospital. Self-report measures. Results indicate the presurgery patients were more congruent in their perceptions of WSC compared with their postsurgery peers and emerging/early adulthood patients were more congruent in their perceptions of WSC compared with middle/late adulthood patients. No gender differences emerged in the full sample, but when divided by surgical status, presurgery females reported more congruent perceptions of WSC compared with their postsurgery peers. Males did not differ in their rates of congruence. These rates of incongruence may suggest a need for assessment of patients' perceived WSC, particularly postsurgery. Published by Elsevier Inc.

Prospective validation of a near real-time EHR-integrated automated SOFA score calculator.

PubMed

Aakre, Christopher; Franco, Pablo Moreno; Ferreyra, Micaela; Kitson, Jaben; Li, Man; Herasevich, Vitaly

2017-07-01

We created an algorithm for automated Sequential Organ Failure Assessment (SOFA) score calculation within the Electronic Health Record (EHR) to facilitate detection of sepsis based on the Third International Consensus Definitions for Sepsis and Septic Shock (SEPSIS-3) clinical definition. We evaluated the accuracy of near real-time and daily automated SOFA score calculation compared with manual score calculation. Automated SOFA scoring computer programs were developed using available EHR data sources and integrated into a critical care focused patient care dashboard at Mayo Clinic in Rochester, Minnesota. We prospectively compared the accuracy of automated versus manual calculation for a sample of patients admitted to the medical intensive care unit at Mayo Clinic Hospitals in Rochester, Minnesota and Jacksonville, Florida. Agreement was calculated with Cohen's kappa statistic. Reason for discrepancy was tabulated during manual review. Random spot check comparisons were performed 134 times on 27 unique patients, and daily SOFA score comparisons were performed for 215 patients over a total of 1206 patient days. Agreement between automatically scored and manually scored SOFA components for both random spot checks (696 pairs, κ=0.89) and daily calculation (5972 pairs, κ=0.89) was high. The most common discrepancies were in the respiratory component (inaccurate fraction of inspired oxygen retrieval; 200/1206) and creatinine (normal creatinine in patients with no urine output on dialysis; 128/1094). 147 patients were at risk of developing sepsis after intensive care unit admission, 10 later developed sepsis confirmed by chart review. All were identified before onset of sepsis with the ΔSOFA≥2 point criterion and 46 patients were false-positives. Near real-time automated SOFA scoring was found to have strong agreement with manual score calculation and may be useful for the detection of sepsis utilizing the new SEPSIS-3 definition. Copyright © 2017 Elsevier B.V. All rights reserved.

A reanalysis of the Cu-7 intrauterine contraceptive device clinical trial and the incidence of pelvic inflammatory disease: a paradigm for assessing intrauterine contraceptive device safety.

PubMed

Roy, S; Azen, C

1994-06-01

We calculated and compared the incidence of pelvic inflammatory disease in a 10% random sample of the Cu-7 intrauterine contraceptive device (G.D. Searle & Co., Skokie, Ill.) clinical trial with the rates reported to the Food and Drug Administration and those in subsequent trials published in the world literature. A 10% random sample of the Cu-7 clinical trial was examined because calculations had demonstrated this random sample to be sufficient in size (n = 1614) to detect a difference in rates of pelvic inflammatory disease from those reported to the Food and Drug Administration. An audit of a subset of the patient files, compared with the original files in Skokie, Illinois, confirmed that the files available for analysis were complete. Standard definitions were used to identify cases of pelvic inflammatory disease and to calculate rates of pelvic inflammatory disease. The world literature on Cu-7 clinical trials was reviewed. The calculated crude and Pearl index rates of pelvic inflammatory disease were consistent with those rates previously reported to the Food and Drug Administration and published in the medical literature. Life-table pelvic inflammatory disease rates were not different between nulliparous and parous women and pelvic inflammatory disease did not differ from basal annual rates in fecund women. On the basis of the analysis of this 10% sample, the pelvic inflammatory disease patient rates reported to the Food and Drug Administration for the entire Cu-7 clinical trial are accurate and are similar to those published in the world literature.

Separate patient serum sodium medians from males and females provide independent information on analytical bias.

PubMed

Hansen, Steen Ingemann; Petersen, Per Hyltoft; Lund, Flemming; Fraser, Callum G; Sölétormos, György

2017-10-26

During monitoring of monthly medians of results from patients undertaken to assess analytical stability in routine laboratory performance, the medians for serum sodium for male and female patients were found to be significantly related. Daily, weekly and monthly patient medians of serum sodium for both male and female patients were calculated from results obtained on samples from the population >18 years on three analysers in the hospital laboratory. The half-range of medians was applied as an estimate of the maximum bias. Further, the ratios between the two medians were calculated. The medians of both genders demonstrated dispersions over time, but they were closely connected in like patterns, which were confirmed by the half-range of the ratios of medians for males and females that varied from 0.36% for daily, 0.14% for weekly and 0.036% for monthly ratios over all instruments. The tight relationship between the gender medians for serum sodium is only possible when raw laboratory data are used for calculation. The two patient medians can be used to confirm both and are useful as independent estimates of analytical bias during constant calibration periods. In contrast to the gender combined median, the estimate of analytical bias can be confirmed further by calculation of the ratios of medians for males and females.

Appendectomy: Surgical Removal of the Appendix

MedlinePlus

... Risk Calculator at http://riskcalculator.facs.org/online. 4 AMERICAN COLLEGE OF SURGEONS • SURGICAL PATIENT EDUCATION • www.facs.org/patienteducation Expectations: Preparing for Yo ur Operation Appendectomy SAMPLE Preparing for Your Operation ...

Evaluation of wound healing in diabetic foot ulcer using platelet-rich plasma gel: A single-arm clinical trial.

PubMed

Mohammadi, Mohammad Hossein; Molavi, Behnam; Mohammadi, Saeed; Nikbakht, Mohsen; Mohammadi, Ashraf Malek; Mostafaei, Shayan; Norooznezhad, Amir Hossein; Ghorbani Abdegah, Ali; Ghavamzadeh, Ardeshir

2017-04-01

The aim of the present study was to evaluate the effectiveness of using autologous platelet-rich plasma (PRP) gel for treatment of diabetic foot ulcer (DFU) during the first 4 weeks of the treatment. In this longitudinal and single-arm trial, 100 patients were randomly selected after meeting certain inclusion and exclusion criteria; of these 100 patients, 70 (70%) were enrolled in the trial. After the primary care actions such as wound debridement, the area of each wound was calculated and recorded. The PRP therapy (2mL/cm 2 of ulcers) was performed weekly until the healing time for each patient. We used one sample T-test for healing wounds and Bootstrap resampling approach for reporting confidence interval with 1000 Bootstrap samples. The p-value<0.05 were considered statistically significant. The mean (SD) of DFU duration was 19.71 weeks (4.94) for units sampling. The ratio of subjects who withdrew from the study was calculated to be 2 (2.8%). Average area of 71 ulcers in the mentioned number of cases was calculated to be 6.11cm 2 (SD: 4.37). Also, the mean, median (SD) of healing time was 8.7, 8 weeks (SD: 3.93) except for 2 mentioned cases. According to one sample T-test, wound area (cm 2 ), on average, significantly decreased to 51.9% (CI: 46.7-57.1) through the first four weeks of therapy. Furthermore, significant correlation (0.22) was not found between area of ulcers and healing duration (p-value>0.5). According to the results, PRP could be considered as a candidate treatment for non-healing DFUs as it may prevent future complications such as amputation or death in this pathological phenomenon. Copyright © 2016 Elsevier Ltd. All rights reserved.

Power Calculations and Placebo Effect for Future Clinical Trials in Progressive Supranuclear Palsy

PubMed Central

Stamelou, Maria; Schöpe, Jakob; Wagenpfeil, Stefan; Ser, Teodoro Del; Bang, Jee; Lobach, Iryna Y.; Luong, Phi; Respondek, Gesine; Oertel, Wolfgang H.; Boxer, Adam L.; Höglinger, Günter U.

2016-01-01

Background Two recent randomized, placebo-controlled trials of putative disease-modifying agents (davunetide, tideglusib) in progressive supranuclear palsy (PSP) failed to show efficacy, but generated data relevant for future trials. Methods We provide sample size calculations based on data collected in 187 PSP patients assigned to placebo in these trials. A placebo effect was calculated. Results The total PSP-Rating Scale required the least number of patients per group (N = 51) to detect a 50% change in the 1-year progression and 39 when including patients with ≤ 5 years disease duration. The Schwab and England Activities of Daily Living required 70 patients per group and was highly correlated with the PSP-Rating Scale. A placebo effect was not detected in these scales. Conclusions We propose the 1-year PSP-Rating Scale score change as the single primary readout in clinical neuroprotective or disease-modifying trials. The Schwab and England Activities of Daily Living could be used as a secondary outcome. PMID:26948290

[Epidemiology of atherogenic dyslipidemia in an urban area of the city of Barcelona].

PubMed

Caballero Sarmiento, Rafael

2014-01-01

We performed a descriptive cross-sectional epidemiological study data on lipid profile and blood glucose of sample collected in 2021 consecutive and anonymous patients. We calculated the prevalence of atherogenic dyslipidemia by sex, according to several cutoff HDL cholesterol in women, and in the whole sample, and its association with diabetes. There is in the study selection bias, as it is performed in patients attending in a Primary Care Laboratory and not in a sample of the general population. Prevalence epidemiological data are therefore approximate and provisional. Copyright © 2013 Elsevier España, S.L. y SEA. All rights reserved.

High sensitivity Troponin T: an audit of implementation of its protocol in a district general hospital.

PubMed

Kalim, Shahid; Nazir, Shaista; Khan, Zia Ullah

2013-01-01

Protocols based on newer high sensitivity Troponin T (hsTropT) assays can rule in a suspected Acute Myocardial Infarction (AMI) as early as 3 hours. We conducted this study to audit adherence to our Trust's newly introduced AMI diagnostic protocol based on paired hsTropT testing at 0 and 3 hours. We retrospectively reviewed data of all patients who had hsTropT test done between 1st and 7th May 2012. Patient's demographics, utility of single or paired samples, time interval between paired samples, patient's presenting symptoms and ECG findings were noted and their means, medians, Standard deviations and proportions were calculated. A total of 66 patients had hsTropT test done during this period. Mean age was 63.30 +/- 17.46 years and 38 (57.57%) were males. Twenty-four (36.36%) patients had only single, rather than protocol recommended paired hsTropT samples, taken. Among the 42 (63.63%) patients with paired samples, the mean time interval was found to be 4.41 +/- 5.7 hours. Contrary to the recommendations, 15 (22.73%) had a very long whereas 2 (3.03%) had a very short time interval between two samples. A subgroup analysis of patients with single samples, found only 2 (3.03%) patient with ST-segment elevation, appropriate for single testing. Our study confirmed that in a large number of patients the protocol for paired sampling or a recommended time interval of 3 hours between 2 samples was not being followed.

The influence of tinnitus acceptance on the quality of life and psychological distress in patients with chronic tinnitus

PubMed Central

Riedl, David; Rumpold, Gerhard; Schmidt, Annette; Zorowka, Patrick G.; Bliem, Harald R.; Moschen, Roland

2015-01-01

Recent findings show the importance of acceptance in the treatment of chronic tinnitus. So far, very limited research investigating the different levels of tinnitus acceptance has been conducted. The aim of this study was to investigate the quality of life (QoL) and psychological distress in patients with chronic tinnitus who reported different levels of tinnitus acceptance. The sample consisted of outpatients taking part in a tinnitus coping group (n = 97). Correlations between tinnitus acceptance, psychological distress, and QoL were calculated. Receiver operating characteristic (ROC) curves were used to calculate a cutoff score for the German “Tinnitus Acceptance Questionnaire” (CTAQ-G) and to evaluate the screening abilities of the CTAQ-G. Independent sample t-tests were conducted to compare QoL and psychological distress in patients with low tinnitus acceptance and high tinnitus acceptance. A cutoff point for CTAQ-G of 62.5 was defined, differentiating between patients with “low-to-mild tinnitus acceptance” and “moderate-to-high tinnitus acceptance.” Patients with higher levels of tinnitus acceptance reported a significantly higher QoL and lower psychological distress. Tinnitus acceptance plays an important role for patients with chronic tinnitus. Increased levels of acceptance are related to better QoL and less psychological distress. PMID:26356381

Using a colorimeter to develop an intrinsic silicone shade guide for facial prostheses.

PubMed

Over, L M; Andres, C J; Moore, B K; Goodacre, C J; Muñoz, C A

1998-12-01

To determine if using CIE L*a*b* color measurements of white facial skin could be correlated to those of silicone shade samples that visually matched the skin. Secondly, to see if a correlation in color measurements could be achieved between the silicone shade samples and duplicated silicone samples made using a shade-guide color formula. A color booth was designed according to ASTM specifications, and painted using a Munsell Value 8 gray. A Minolta colorimeter was used to make facial skin measurements on 15 white adults. The skin color was duplicated using custom-shaded silicone samples. A 7-step wedge silicone shade guide was then fabricated, representing the commonly encountered thicknesses when fabricating facial prostheses. The silicone samples were then measured with the Minolta colorimeter. The readings were compared with the previous L*a*b* readings from the corresponding patient's skin measurements, and the relative color difference was then calculated. Silicone samples were fabricated and analyzed for three of the patients to determine if duplication of the visually matched silicone specimen was possible using the silicone color formula, and if the duplicates were visually and colorimetrically equivalent to each other. The color difference Delta E and chromaticity was calculated, and the data were analyzed using a coefficient-of-variation formula expressed by percent. A Pearson Product Moment Correlation Coefficient was performed to determine if a correlation existed between the skin and the silicone samples at the p < or = .05 level. The highest correlation was found in the b* dimension for silicone thicknesses of 1 to 4 mm. For silicone thicknesses of 6 to 10 mm, the highest correlation was found in the L* dimension. All three dimensions had positive correlations (R2 > 0), but only the 1-mm and 4-mm b* readings were very strong. Patient and silicone L*a*b* measurement results showed very little change in the a* axis, while the L* and b* measurements showed more change in their numbers, with changes in depth for all patient silicone samples. Delta E numbers indicated the lowest Delta E at the 1-mm depth and the highest Delta E at the 10-mm depth. All duplicated samples matched their original silicone samples to a degree that visual evaluation could not distinguish any color differences. Using volumetric measurements, a shade guide was developed for all 15 patients. There was good correlation between the patient's colorimeter measurements and the silicone samples, with the b* color dimension the most reproducible, followed by the L* and the a*. Silicone samples at 6, 8, and 10 mm matched the patient the best, and this study showed that silicone samples can be duplicated successfully if a good patient-silicone match is obtained. Rayon flocking fibers and liquid makeup are effective at matching facial prostheses and can be used to develop a simple shade guide for patient application.

Work-related discussions between French rheumatologists and their rheumatoid arthritis patients.

PubMed

Meunier, J; Fautrel, B; Roquelaure, Y; Claudepierre, P

2016-08-01

Rheumatoid arthritis (RA) causes significant impairment of physical function, and thus adversely affects patients' ability to work. To document how often work limitations are discussed by rheumatologists and RA patients during consultations. We conducted an observational study in a sample of French rheumatologists and in a parallel sample of patients recruited by pharmacists. We asked all rheumatologists in France practising in private practice or mixed practice (private practice and hospital) to participate in a telephone survey about their most recent consultation with an RA patient. Randomly selected pharmacists recruited RA patients to complete a questionnaire about their most recent consultation with their rheumatologist. We included patients aged 20-59, with a paid job or unemployed. We calculated the proportion of consultations including work-related discussions in both samples. Of the 1737 rheumatologists contacted, 153 (9%) described consultations with eligible patients. Of the 1200 pharmacists contacted, 39 (3%) recruited 81 RA patients. The proportion of consultations including work-related discussions was 50% [95% confidence interval (CI) 42-58%] in the rheumatologist sample and 52% (95% CI 41-63%) in the patient sample. The most frequent subject of discussion (88%) was physical problems related to work in both samples. This is the first study to document the proportion of consultations where rheumatologists and their RA patients discuss work. Both specialists and patients reported that work was discussed in one in every two consultations. © The Author 2016. Published by Oxford University Press on behalf of the Society of Occupational Medicine. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Rubella virus as a possible etiological agent of Fuchs heterochromic iridocyclitis.

PubMed

Suzuki, Jun; Goto, Hiroshi; Komase, Katsuhiro; Abo, Hitoshi; Fujii, Kaoru; Otsuki, Noriyuki; Okamoto, Kiyoko

2010-10-01

To determine whether rubella virus is involved in the pathogenesis of Fuchs heterochromic iridocyclitis (FHI). Fourteen patients (14 eyes) diagnosed with FHI based on characteristic ocular manifestations and eight control subjects were studied. Aqueous humor (AH) samples from 14 FHI patients and one vitreous sample from a FHI patient were analyzed for intraocular antibody production against rubella virus by calculation of the Goldmann-Witmer coefficient (GWC). Viral detection by nested polymerase chain reaction and isolation by culture in RK-13 cells were conducted in nine FHI patients. In addition to laboratory examinations, medical history of rubella virus vaccination was also obtained. Ten patients with FHI examined showed intraocular synthesis of rubella virus antibodies (GWC > 3). A high index of rubella virus antibody production was also found in the vitreous sample (GWC = 30.6). GWC in all control subjects were below detectable level. The rubella genome was detected in two of nine patients, and rubella virus was isolated from one of nine patients with FHI. None of the patients with FHI had been vaccinated against rubella. Our laboratory data strongly suggest a relationship between FHI and rubella virus.

Development and Validation of a Novel Pediatric Appendicitis Risk Calculator (pARC).

PubMed

Kharbanda, Anupam B; Vazquez-Benitez, Gabriela; Ballard, Dustin W; Vinson, David R; Chettipally, Uli K; Kene, Mamata V; Dehmer, Steven P; Bachur, Richard G; Dayan, Peter S; Kuppermann, Nathan; O'Connor, Patrick J; Kharbanda, Elyse O

2018-04-01

We sought to develop and validate a clinical calculator that can be used to quantify risk for appendicitis on a continuous scale for patients with acute abdominal pain. The pediatric appendicitis risk calculator (pARC) was developed and validated through secondary analyses of 3 distinct cohorts. The derivation sample included visits to 9 pediatric emergency departments between March 2009 and April 2010. The validation sample included visits to a single pediatric emergency department from 2003 to 2004 and 2013 to 2015. Variables evaluated were as follows: age, sex, temperature, nausea and/or vomiting, pain duration, pain location, pain with walking, pain migration, guarding, white blood cell count, and absolute neutrophil count. We used stepwise regression to develop and select the best model. Test performance of the pARC was compared with the Pediatric Appendicitis Score (PAS). The derivation sample included 2423 children, 40% of whom had appendicitis. The validation sample included 1426 children, 35% of whom had appendicitis. The final pARC model included the following variables: sex, age, duration of pain, guarding, pain migration, maximal tenderness in the right-lower quadrant, and absolute neutrophil count. In the validation sample, the pARC exhibited near perfect calibration and a high degree of discrimination (area under the curve: 0.85; 95% confidence interval: 0.83 to 0.87) and outperformed the PAS (area under the curve: 0.77; 95% confidence interval: 0.75 to 0.80). By using the pARC, almost half of patients in the validation cohort could be accurately classified as at <15% risk or ≥85% risk for appendicitis, whereas only 23% would be identified as having a comparable PAS of <3 or >8. In our validation cohort of patients with acute abdominal pain, the pARC accurately quantified risk for appendicitis. Copyright © 2018 by the American Academy of Pediatrics.

Evaluation of Sampling Recommendations From the Influenza Virologic Surveillance Right Size Roadmap for Idaho.

PubMed

Rosenthal, Mariana; Anderson, Katey; Tengelsen, Leslie; Carter, Kris; Hahn, Christine; Ball, Christopher

2017-08-24

The Right Size Roadmap was developed by the Association of Public Health Laboratories and the Centers for Disease Control and Prevention to improve influenza virologic surveillance efficiency. Guidelines were provided to state health departments regarding representativeness and statistical estimates of specimen numbers needed for seasonal influenza situational awareness, rare or novel influenza virus detection, and rare or novel influenza virus investigation. The aim of this study was to compare Roadmap sampling recommendations with Idaho's influenza virologic surveillance to determine implementation feasibility. We calculated the proportion of medically attended influenza-like illness (MA-ILI) from Idaho's influenza-like illness surveillance among outpatients during October 2008 to May 2014, applied data to Roadmap-provided sample size calculators, and compared calculations with actual numbers of specimens tested for influenza by the Idaho Bureau of Laboratories (IBL). We assessed representativeness among patients' tested specimens to census estimates by age, sex, and health district residence. Among outpatients surveilled, Idaho's mean annual proportion of MA-ILI was 2.30% (20,834/905,818) during a 5-year period. Thus, according to Roadmap recommendations, Idaho needs to collect 128 specimens from MA-ILI patients/week for situational awareness, 1496 influenza-positive specimens/week for detection of a rare or novel influenza virus at 0.2% prevalence, and after detection, 478 specimens/week to confirm true prevalence is ≤2% of influenza-positive samples. The mean number of respiratory specimens Idaho tested for influenza/week, excluding the 2009-2010 influenza season, ranged from 6 to 24. Various influenza virus types and subtypes were collected and specimen submission sources were representative in terms of geographic distribution, patient age range and sex, and disease severity. Insufficient numbers of respiratory specimens are submitted to IBL for influenza laboratory testing. Increased specimen submission would facilitate meeting Roadmap sample size recommendations. ©Mariana Rosenthal, Katey Anderson, Leslie Tengelsen, Kris Carter, Christine Hahn, Christopher Ball. Originally published in JMIR Public Health and Surveillance (http://publichealth.jmir.org), 24.08.2017.

Blood glucose level reconstruction as a function of transcapillary glucose transport.

PubMed

Koutny, Tomas

2014-10-01

A diabetic patient occasionally undergoes a detailed monitoring of their glucose levels. Over the course of a few days, a monitoring system provides a detailed track of their interstitial fluid glucose levels measured in their subcutaneous tissue. A discrepancy in the blood and interstitial fluid glucose levels is unimportant because the blood glucose levels are not measured continuously. Approximately five blood glucose level samples are taken per day, and the interstitial fluid glucose level is usually measured every 5min. An increased frequency of blood glucose level sampling would cause discomfort for the patient; thus, there is a need for methods to estimate blood glucose levels from the glucose levels measured in subcutaneous tissue. The Steil-Rebrin model is widely used to describe the relationship between blood and interstitial fluid glucose dynamics. However, we measured glucose level patterns for which the Steil-Rebrin model does not hold. Therefore, we based our research on a different model that relates present blood and interstitial fluid glucose levels to future interstitial fluid glucose levels. Using this model, we derived an improved model for calculating blood glucose levels. In the experiments conducted, this model outperformed the Steil-Rebrin model while introducing no additional requirements for glucose sample collection. In subcutaneous tissue, 26.71% of the calculated blood glucose levels had absolute values of relative differences from smoothed measured blood glucose levels less than or equal to 5% using the Steil-Rebrin model. However, the same difference interval was encountered in 63.01% of the calculated blood glucose levels using the proposed model. In addition, 79.45% of the levels calculated with the Steil-Rebrin model compared with 95.21% of the levels calculated with the proposed model had 20% difference intervals. Copyright © 2014 Elsevier Ltd. All rights reserved.

The effect of resolution on viscous dissipation measured with 4D flow MRI in patients with Fontan circulation: Evaluation using computational fluid dynamics

PubMed Central

Cibis, Merih; Jarvis, Kelly; Markl, Michael; Rose, Michael; Rigsby, Cynthia; Barker, Alex J.; Wentzel, Jolanda J.

2016-01-01

Viscous dissipation inside Fontan circulation, a parameter associated with the exercise intolerance of Fontan patients, can be derived from computational fluid dynamics (CFD) or 4D flow MRI velocities. However, the impact of spatial resolution and measurement noise on the estimation of viscous dissipation is unclear. Our aim was to evaluate the influence of these parameters on viscous dissipation calculation. Six Fontan patients underwent whole heart 4D flow MRI. Subject-specific CFD simulations were performed. The CFD velocities were down-sampled to isotropic spatial resolutions of 0.5 mm, 1 mm, 2 mm and to MRI resolution. Viscous dissipation was compared between (1) high resolution CFD velocities, (2) CFD velocities down-sampled to MRI resolution, (3) down-sampled CFD velocities with MRI mimicked noise levels, and (4) in-vivo 4D flow MRI velocities. Relative viscous dissipation between subjects was also calculated. 4D flow MRI velocities (15.6±3.8 cm/s) were higher, although not significantly different than CFD velocities (13.8±4.7 cm/s, p=0.16), down-sampled CFD velocities (12.3±4.4 cm/s, p=0.06) and the down-sampled CFD velocities with noise (13.2±4.2 cm/s, p=0.06). CFD-based viscous dissipation (0.81±0.55 mW) was significantly higher than those based on down-sampled CFD (0.25±0.19 mW, p=0.03), down-sampled CFD with noise (0.49±0.26 mW, p=0.03) and 4D flow MRI (0.56±0.28 mW, p=0.06). Nevertheless, relative viscous dissipation between different subjects was maintained irrespective of resolution and noise, suggesting that comparison of viscous dissipation between patients is still possible. PMID:26298492

Evaluation of AUC(0-4) predictive methods for cyclosporine in kidney transplant patients.

PubMed

Aoyama, Takahiko; Matsumoto, Yoshiaki; Shimizu, Makiko; Fukuoka, Masamichi; Kimura, Toshimi; Kokubun, Hideya; Yoshida, Kazunari; Yago, Kazuo

2005-05-01

Cyclosporine (CyA) is the most commonly used immunosuppressive agent in patients who undergo kidney transplantation. Dosage adjustment of CyA is usually based on trough levels. Recently, trough levels have been replacing the area under the concentration-time curve during the first 4 h after CyA administration (AUC(0-4)). The aim of this study was to compare the predictive values obtained using three different methods of AUC(0-4) monitoring. AUC(0-4) was calculated from 0 to 4 h in early and stable renal transplant patients using the trapezoidal rule. The predicted AUC(0-4) was calculated using three different methods: the multiple regression equation reported by Uchida et al.; Bayesian estimation for modified population pharmacokinetic parameters reported by Yoshida et al.; and modified population pharmacokinetic parameters reported by Cremers et al. The predicted AUC(0-4) was assessed on the basis of predictive bias, precision, and correlation coefficient. The predicted AUC(0-4) values obtained using three methods through measurement of three blood samples showed small differences in predictive bias, precision, and correlation coefficient. In the prediction of AUC(0-4) measurement of one blood sample from stable renal transplant patients, the performance of the regression equation reported by Uchida depended on sampling time. On the other hand, the performance of Bayesian estimation with modified pharmacokinetic parameters reported by Yoshida through measurement of one blood sample, which is not dependent on sampling time, showed a small difference in the correlation coefficient. The prediction of AUC(0-4) using a regression equation required accurate sampling time. In this study, the prediction of AUC(0-4) using Bayesian estimation did not require accurate sampling time in the AUC(0-4) monitoring of CyA. Thus Bayesian estimation is assumed to be clinically useful in the dosage adjustment of CyA.

Orofacial myofunctional disorder in subjects with temporomandibular disorder.

PubMed

Ferreira, Cláudia Lúcia Pimenta; Da Silva, Marco Antônio M Rodrigues; de Felício, Cláudia Maria

2009-10-01

To determine the frequency and degree of orofacial myofunctional disorder (OMD) in a sample of patients with temporomandibular disorder (TMD), the dental records of 240 patients with a diagnosis of TMD were reviewed. Mean patient age and mean TMD duration, gender frequency, complaints, and signs and symptoms were calculated. The results showed that the sample studied was quite characteristic of a TMD group. The presence of the following signs/symptoms was significant: muscular pain, TMJ pain, joint noise, at least one otologic symptom, headache, and neck and shoulder pain. Most subjects presented some degree of OMD, with grade high prevailing over grade low. The importance of evaluating the stomatognathic structures and functions during the clinical examination of patients with TMD is emphasized.

Development and evaluation of a novel LAMP assay for the diagnosis of Cutaneous and Visceral Leishmaniasis.

PubMed

Adams, Emily Rebecca; Schoone, Gerard; Versteeg, Inge; Gomez, Maria Adelaida; Diro, Ermias; Mori, Yasuyoshi; Perlee, Desiree; Downing, Tim; Saravia, Nancy; Assaye, Ashenafi; Hailu, Asrat; Albertini, Audrey; Ndung'u, Joseph Mathu; Schallig, Henk

2018-04-25

A novel Pan-Leishmania LAMP assay was developed for diagnosis of Cutaneous and Visceral Leishmaniasis (CL & VL) which can be used in near-patient settings. Primers were designed on the 18S rDNA and the conserved region of minicircle kDNA selected on the basis of high copy number. LAMP assays were evaluated for CL in a prospective cohort trial of 105 patients in South-West Colombia. Lesion swab samples from CL suspects were collected and tested using LAMP and compared to a composite reference of microscopy AND/OR culture to calculate diagnostic accuracy. LAMP assays were tested on 50 VL suspected patients from Ethiopia, including whole blood, peripheral blood mononuclear cells, and buffy coat. Diagnostic accuracy was calculated against a reference standard of microscopy of splenic or bone marrow aspirates. To calculate analytical specificity 100 clinical samples and isolates with fever causing pathogens including malaria, arboviruses and bacterial infections were tested. The LAMP assay had a sensitivity of 95% (95% CI: 87.2% - 98.5 %) and a specificity of 86% (95% CI: 67.3% -95.9 %) for the diagnosis of CL. On VL suspects the sensitivity was 92% (95% CI: 74.9 - 99.1%) and specificity of 100% (95% CI: 85.8-100%) in whole blood. For CL, LAMP is a sensitive tool for diagnosis and requires less equipment, time and expertise than alternative CL diagnostics. For VL, LAMP is sensitive using a minimally invasive sample as compared to the gold standard. The analytical specificity was 100%. Copyright © 2018 Adams et al.

Do prices reflect the costs of cardiac surgery in the elderly?

PubMed

Coelho, Pedro; Rodrigues, Vanessa; Miranda, Luís; Fragata, José; Pita Barros, Pedro

2017-01-01

Payment for cardiac surgery in Portugal is based on a contract agreement between hospitals and the health ministry. Our aim was to compare the prices paid according to this contract agreement with calculated costs in a population of patients aged ≥65 years undergoing cardiac surgery in one hospital department. Data on 250 patients operated between September 2011 and September 2012 were prospectively collected. The procedures studied were coronary artery bypass graft surgery (CABG) (n=67), valve surgery (n=156) and combined CABG and valve surgery (n=27). Costs were calculated by two methods: micro-costing when feasible and mean length of stay otherwise. Price information was provided by the hospital administration and calculated using the hospital's mean case-mix. Thirty-day mortality was 3.2%. Mean EuroSCORE I was 5.97 (standard deviation [SD] 4.5%), significantly lower for CABG (p<0.01). Mean intensive care unit stay was 3.27 days (SD 4.7) and mean hospital stay was 9.92 days (SD 6.30), both significantly shorter for CABG. Calculated costs for CABG were €6539.17 (SD 3990.26), for valve surgery €8289.72 (SD 3319.93) and for combined CABG and valve surgery €11 498.24 (SD 10 470.57). The payment for each patient was €4732.38 in 2011 and €4678.66 in 2012 based on the case-mix index of the hospital group, which was 2.06 in 2011 and 2.21 in 2012; however, the case-mix in our sample was 6.48 in 2011 and 6.26 in 2012. The price paid for each patient was lower than the calculated costs. Prices would be higher than costs if the case-mix of the sample had been used. Costs were significantly lower for CABG. Copyright © 2016 Sociedade Portuguesa de Cardiologia. Publicado por Elsevier España, S.L.U. All rights reserved.

Development and validation of effective real-time and periodic interinstrument comparison method for automatic hematology analyzers.

PubMed

Park, Sang Hyuk; Park, Chan-Jeoung; Kim, Mi-Jeong; Choi, Mi-Ok; Han, Min-Young; Cho, Young-Uk; Jang, Seongsoo

2014-12-01

We developed and validated an interinstrument comparison method for automatic hematology analyzers based on the 99th percentile coefficient of variation (CV) cutoff of daily means and validated in both patient samples and quality control (QC) materials. A total of 120 patient samples were obtained over 6 months. Data from the first 3 months were used to determine 99th percentile CV cutoff values, and data obtained in the last 3 months were used to calculate acceptable ranges and rejection rates. Identical analyses were also performed using QC materials. Two instrument comparisons were also performed, and the most appropriate allowable total error (ATE) values were determined. The rejection rates based on the 99th percentile cutoff values were within 10.00% and 9.30% for the patient samples and QC materials, respectively. The acceptable ranges of QC materials based on the currently used method were wider than those calculated from the 99th percentile CV cutoff values in most items. In two-instrument comparisons, 34.8% of all comparisons failed, and 87.0% of failed comparisons were successful when 4 SD was applied as an ATE value instead of 3 SD. The 99th percentile CV cutoff value-derived daily acceptable ranges can be used as a real-time interinstrument comparison method in both patient samples and QC materials. Applying 4 SD as an ATE value can significantly reduce unnecessarily followed recalibration in the leukocyte differential counts, reticulocytes, and mean corpuscular volume. Copyright© by the American Society for Clinical Pathology.

Risk score to predict the outcome of patients with cerebral vein and dural sinus thrombosis.

PubMed

Ferro, José M; Bacelar-Nicolau, Helena; Rodrigues, Teresa; Bacelar-Nicolau, Leonor; Canhão, Patrícia; Crassard, Isabelle; Bousser, Marie-Germaine; Dutra, Aurélio Pimenta; Massaro, Ayrton; Mackowiack-Cordiolani, Marie-Anne; Leys, Didier; Fontes, João; Stam, Jan; Barinagarrementeria, Fernando

2009-01-01

Around 15% of patients die or become dependent after cerebral vein and dural sinus thrombosis (CVT). We used the International Study on Cerebral Vein and Dural Sinus Thrombosis (ISCVT) sample (624 patients, with a median follow-up time of 478 days) to develop a Cox proportional hazards regression model to predict outcome, dichotomised by a modified Rankin Scale score >2. From the model hazard ratios, a risk score was derived and a cut-off point selected. The model and the score were tested in 2 validation samples: (1) the prospective Cerebral Venous Thrombosis Portuguese Collaborative Study Group (VENOPORT) sample with 91 patients; (2) a sample of 169 consecutive CVT patients admitted to 5 ISCVT centres after the end of the ISCVT recruitment period. Sensitivity, specificity, c statistics and overall efficiency to predict outcome at 6 months were calculated. The model (hazard ratios: malignancy 4.53; coma 4.19; thrombosis of the deep venous system 3.03; mental status disturbance 2.18; male gender 1.60; intracranial haemorrhage 1.42) had overall efficiencies of 85.1, 84.4 and 90.0%, in the derivation sample and validation samples 1 and 2, respectively. Using the risk score (range from 0 to 9) with a cut-off of >or=3 points, overall efficiency was 85.4, 84.4 and 90.1% in the derivation sample and validation samples 1 and 2, respectively. Sensitivity and specificity in the combined samples were 96.1 and 13.6%, respectively. The CVT risk score has a good estimated overall rate of correct classifications in both validation samples, but its specificity is low. It can be used to avoid unnecessary or dangerous interventions in low-risk patients, and may help to identify high-risk CVT patients. (c) 2009 S. Karger AG, Basel.

A stochastic convolution/superposition method with isocenter sampling to evaluate intrafraction motion effects in IMRT.

PubMed

Naqvi, Shahid A; D'Souza, Warren D

2005-04-01

Current methods to calculate dose distributions with organ motion can be broadly classified as "dose convolution" and "fluence convolution" methods. In the former, a static dose distribution is convolved with the probability distribution function (PDF) that characterizes the motion. However, artifacts are produced near the surface and around inhomogeneities because the method assumes shift invariance. Fluence convolution avoids these artifacts by convolving the PDF with the incident fluence instead of the patient dose. In this paper we present an alternative method that improves the accuracy, generality as well as the speed of dose calculation with organ motion. The algorithm starts by sampling an isocenter point from a parametrically defined space curve corresponding to the patient-specific motion trajectory. Then a photon is sampled in the linac head and propagated through the three-dimensional (3-D) collimator structure corresponding to a particular MLC segment chosen randomly from the planned IMRT leaf sequence. The photon is then made to interact at a point in the CT-based simulation phantom. Randomly sampled monoenergetic kernel rays issued from this point are then made to deposit energy in the voxels. Our method explicitly accounts for MLC-specific effects (spectral hardening, tongue-and-groove, head scatter) as well as changes in SSD with isocentric displacement, assuming that the body moves rigidly with the isocenter. Since the positions are randomly sampled from a continuum, there is no motion discretization, and the computation takes no more time than a static calculation. To validate our method, we obtained ten separate film measurements of an IMRT plan delivered on a phantom moving sinusoidally, with each fraction starting with a random phase. For 2 cm motion amplitude, we found that a ten-fraction average of the film measurements gave an agreement with the calculated infinite fraction average to within 2 mm in the isodose curves. The results also corroborate the existing notion that the interfraction dose variability due to the interplay between the MLC motion and breathing motion averages out over typical multifraction treatments. Simulation with motion waveforms more representative of real breathing indicate that the motion can produce penumbral spreading asymmetric about the static dose distributions. Such calculations can help a clinician decide to use, for example, a larger margin in the superior direction than in the inferior direction. In the paper we demonstrate that a 15 min run on a single CPU can readily illustrate the effect of a patient-specific breathing waveform, and can guide the physician in making informed decisions about margin expansion and dose escalation.

Dose coverage calculation using a statistical shape model—applied to cervical cancer radiotherapy

NASA Astrophysics Data System (ADS)

Tilly, David; van de Schoot, Agustinus J. A. J.; Grusell, Erik; Bel, Arjan; Ahnesjö, Anders

2017-05-01

A comprehensive methodology for treatment simulation and evaluation of dose coverage probabilities is presented where a population based statistical shape model (SSM) provide samples of fraction specific patient geometry deformations. The learning data consists of vector fields from deformable image registration of repeated imaging giving intra-patient deformations which are mapped to an average patient serving as a common frame of reference. The SSM is created by extracting the most dominating eigenmodes through principal component analysis of the deformations from all patients. The sampling of a deformation is thus reduced to sampling weights for enough of the most dominating eigenmodes that describe the deformations. For the cervical cancer patient datasets in this work, we found seven eigenmodes to be sufficient to capture 90% of the variance in the deformations of the, and only three eigenmodes for stability in the simulated dose coverage probabilities. The normality assumption of the eigenmode weights was tested and found relevant for the 20 most dominating eigenmodes except for the first. Individualization of the SSM is demonstrated to be improved using two deformation samples from a new patient. The probabilistic evaluation provided additional information about the trade-offs compared to the conventional single dataset treatment planning.

Calculation of the capnographic index based on expiratory molar mass-volume-curves--a suitable tool to screen for cystic fibrosis lung disease.

PubMed

Fuchs, Susanne I; Junge, Sibylle; Ellemunter, Helmut; Ballmann, Manfred; Gappa, Monika

2013-05-01

Volumetric capnography reflecting the course of CO2-exhalation is used to assess ventilation inhomogeneity. Calculation of the slope of expiratory phase 3 and the capnographic index (KPIv) from expirograms allows quantification of extent and severity of small airway impairment. However, technical limitations have hampered more widespread use of this technique. Using expiratory molar mass-volume-curves sampled with a handheld ultrasonic flow sensor during tidal breathing is a novel approach to extract similar information from expirograms in a simpler manner possibly qualifying as a screening tool for clinical routine. The aim of the present study was to evaluate calculation of the KPIv based on molar mass-volume-curves sampled with an ultrasonic flow sensor in patients with CF and controls by assessing feasibility, reproducibility and comparability with the Lung Clearance Index (LCI) derived from multiple breath washout (MBW) used as the reference method. Measurements were performed in patients with CF and healthy controls during a single test occasion using the EasyOne Pro, MBW Module (ndd Medical Technologies, Switzerland). Capnography and MBW were performed in 87/96 patients with CF and 38/42 controls, with a success rate of 90.6% for capnography. Mean age (range) was 12.1 (4-25) years. Mean (SD) KPIv was 6.94 (3.08) in CF and 5.10 (2.06) in controls (p=0.001). Mean LCI (SD) was 8.0 (1.4) in CF and 6.2 (0.4) in controls (p=<0.001) and correlated significantly with the KPIv (p=<0.001). Calculation of the KPIv based on molar mass-volume-curves is feasible. KPIv is significantly different between patients with CF and controls and correlates with the LCI. However, individual data revealed a relevant overlap between patients and controls requiring further evaluation, before this method can be recommended for clinical use. Copyright © 2012 European Cystic Fibrosis Society. Published by Elsevier B.V. All rights reserved.

Clinical validation of a highly sensitive assay to detect EGFR mutations in plasma cell-free DNA from patients with advanced lung adenocarcinoma.

PubMed

Li, Yuping; Xu, Hanyan; Su, Shanshan; Ye, Junru; Chen, Junjie; Jin, Xuru; Lin, Quan; Zhang, Dongqing; Ye, Caier; Chen, Chengshui

2017-01-01

Circulating tumor DNA (ctDNA) is a promising biomarker for noninvasive epidermal growth factor receptor (EGFR) mutations detection in lung cancer patients, but the existing methods have limitations in sensitivity or in availability. In this study, we evaluated the performance of a novel assay called ADx-SuperARMS in detecting EGFR mutations in plasma cell-free DNA from patients with advanced lung adenocarcinoma. A total of 109 patients with metastatic advanced adenocarcinoma were recruited who provided both blood samples and matched tumor tissue samples. EGFR mutation status in plasma samples were tested with ADx-SuperARMS EGFR assay and tumor tissue samples were tested with ADx-ARMS EGFR assay. The clinical sensitivity, specificity, positive prediction value (PPV), and negative prediction value (NPV) of ADx-SuperARMS EGFR assay were calculated by using EGFR mutation status in tumor tissue as standard reference. A receiver operating characteristic (ROC) analysis was implemented and an area under the curve (AUC) was calculated to evaluate sensitivity and specificity of exon 19 deletion (E19Del) and L858R mutation detection. The objective response rate (ORR) were calculated according to the EGFR mutation status determined by ADx-superARMS as well. 0.2% analytical sensitivity and 100% specificity of the ADx-SuperARMS EGFR assays for EGFR E19Del, L858R, and T790M mutants were confirmed by using a series of diluted cell line DNA. In the clinical study, EGFR mutations were detected in 45.9% (50/109) of the plasma samples and in 56.9% (62/109) of the matched tumor tissue samples. The sensitivity, specificity, PPV and NPV of the ADx-SuperARMS EGFR assay for plasma EGFR mutation detection were 82.0% (50/61), 100% (48/48), 100% (50/50), and 81.4% (48/59), respectively. In ROC analysis, ADx-SuperARMS achieved sensitivity and specificity of 88% and 99% in E19Dels as well as sensitivity and specificity of 89% and 100% in L858R, respectively. Among the 35 patients who were plasma EGFR mutation positive and treated with first generation of EGFR-tyrosine kinase inhibitors (TKIs), 23 (65.7%) achieved partial response, 11 (31.4%) sustained disease, and 1 (2.9%) progressive disease. The ORR and disease control rate (DCR) were 65.7% and 97.1%, respectively. ADx-SuperARMS EGFR assay is likely to be a highly sensitive and specific method to noninvasively detect plasma EGFR mutations of patients with advanced lung adenocarcinoma. The EGFR mutations detected by ADx-SuperARMS EGFR assay could predict the efficacy of the treatment with first generation of EGFR-TKIs. Hence, EGFR blood testing with ADx-SuperARMS could address the unmet clinical needs.

Analysis of evolutionary rate of HIV-1 subtype B using blood donor samples in Japan.

PubMed

Shinohara, Naoya; Matsumoto, Chieko; Matsubayashi, Keiji; Nagai, Tadashi; Satake, Masahiro

2018-06-01

There are few reports on HIV-1 intra-host evolutionary rate in asymptomatic treatment-naïve patients. Here, the HIV-1 intra-host evolutionary rate was estimated based on HIV-1 RNA sequences from plasma samples of blood donors in Japan. Blood donors were assumed to have received no treatment for and have no symptoms of HIV-1 infection because they were healthy, and declared no risky behaviors of HIV-1 infection on a self-reported questionnaire or interview followed by donation. HIV-1 RNA was obtained from 85 plasma samples from 36 blood donors who donated blood multiple times and were HIV-1-positive. The C2V3C3 region which encodes for a part of the envelope protein, and the V3 loop in the C2V3C3 region were analyzed by RT-PCR and direct sequencing, and the sequences were compared. The nucleotide substitution rate was calculated by linear regression. All HIV-1 samples analyzed were classified as subtype B. The mean nucleotide substitution rate in C2V3C3 was calculated to be 6.2 × 10 -3 -1.8 × 10 -2 /site/year (V3: 4.5 × 10 -3 -2.3 × 10 -2 /site/year). The mean non-synonymous substitution rate in C2V3C3 was calculated to be 5.2 × 10 -3 -1.7 × 10 -2 /site/year (V3: 4.5 × 10 -3 -2.1 × 10 -2 /site/year). The mean synonymous substitution rate in C2V3C3 was calculated to be 1.1 × 10 -4 -2.3 × 10 -3 /site/year (V3: 2.9 × 10 -3 /site/year). Among HIV-1 subtype B RNA-positive blood donors in Japan, the nucleotide substitution rate in C2V3C3 was estimated to be higher than that of reported cases using HIV-1 samples mainly obtained from AIDS patients. Compared to AIDS patients, immune responses against HIV-1 are probably more effective in HIV-1 RNA-positive blood donors. Consequently, immune pressure presumably promotes mutation of the virus genome.

The impact of patient assistance programs and the 340B Drug Pricing Program on medication cost.

PubMed

Castellon, Yelba M; Bazargan-Hejazi, Shahrzad; Masatsugu, Miles; Contreras, Roberto

2014-02-01

Patient assistance programs and the 340B Drug Pricing Program promise to improve the financial stability, better serve vulnerable patients, and decrease the burden of cost for uninsured patients. Our objective is to examine the financial impact that PAPs and the 340B Program have on improving medication cost. Retrospective analysis of medication dispensary data. Dispensary data for uninsured patients obtaining medications at 2 community health centers were collected from February 1 to February 29, 2012. Uninsured patients were divided into 2 samples: (1) patients receiving PAP medications and (2) patients receiving 340B medications. The main outcome measured was the patient's cost savings. Cost savings were calculated based on the amount a medication would have cost had it been purchased by patients at prices found on Epocrates software (drugstore.com). A paired sample t test model using continuous variables was utilized to calculate confidence intervals. A total of 1420 PAP and 2772 340B individual medications were dispensed to uninsured patients in February 2012. For patients receiving PAP medications the mean ± standard deviation (SD) for age = 52 ± 10. Average cost was $0.11 (95% CI, $0.04-$0.17) and average savings was $617.36 (95% Cl, $581.32-$653.40). For patients receiving 340B medications the mean ±SD for age = 50 ± 14. Average cost was $11.50 (95% CI, $10.55-$12.45). Average saving was $62.31 (95% CI, $57.99-$66.63). PAPs and 340B provide significant medication savings for uninsured patient. More research is needed to establish "best practices" for the successful integration of PAPs.

The impact of restorative treatment on tooth loss prevention.

PubMed

Caldas Junior, Arnaldo de França; Silveira, Renata Cimões Jovino; Marcenes, Wagner

2003-01-01

A cross-sectional study was carried out to analyze tooth loss resulting from caries in relation to the number of times the extracted tooth had been restored, the type of caries diagnosed (primary or secondary), and socioeconomic indicators of patients from the city of Recife, Brazil. Ten public health centres and ten centres associated with health insurance companies were randomly selected. The size of the sample was calculated using a standard error of 2.5%. A confidence interval of 95% and a 50% prevalence of reasons for extractions were used for calculating the sample. The minimum size of the sample for meeting these requirements was 381 patients. Patients were randomly selected from the list of adults registered at each centre. A total of 410 patients were invited to take part in the study. The response rate was 100%, but 6 patients were excluded due to incompleteness of data in the questionnaire applied. An assessment was made to obtain the number of decayed, missing or filled teeth (DMFT index) and the reasons for extraction. The results showed a highly significant (p < 0.001) relationship between the number of times the tooth indicated for extraction had been restored and the reason for extraction being caries. Furthermore, the majority of teeth extracted due to caries had been restored two or more times. A highly statistically significant association was also observed between one indicator of use of dental services (F/DMFT) and extraction due to caries (p < 0.001). The findings questioned the belief that tooth loss can be prevented in the general population by merely providing restorative treatment.

Psychometric properties of the Spanish version of the Mindful Attention Awareness Scale (MAAS) in patients with fibromyalgia.

PubMed

Cebolla, Ausias; Luciano, Juan V; DeMarzo, Marcelo Piva; Navarro-Gil, Mayte; Campayo, Javier Garcia

2013-01-14

Mindful-based interventions improve functioning and quality of life in fibromyalgia (FM) patients. The aim of the study is to perform a psychometric analysis of the Spanish version of the Mindful Attention Awareness Scale (MAAS) in a sample of patients diagnosed with FM. The following measures were administered to 251 Spanish patients with FM: the Spanish version of MAAS, the Chronic Pain Acceptance Questionnaire, the Pain Catastrophising Scale, the Injustice Experience Questionnaire, the Psychological Inflexibility in Pain Scale, the Fibromyalgia Impact Questionnaire and the Euroqol. Factorial structure was analysed using Confirmatory Factor Analyses (CFA). Cronbach's α coefficient was calculated to examine internal consistency, and the intraclass correlation coefficient (ICC) was calculated to assess the test-retest reliability of the measures. Pearson's correlation tests were run to evaluate univariate relationships between scores on the MAAS and criterion variables. The MAAS scores in our sample were low (M = 56.7; SD = 17.5). CFA confirmed a two-factor structure, with the following fit indices [sbX2 = 172.34 (p < 0.001), CFI = 0.95, GFI = 0.90, SRMR = 0.05, RMSEA = 0.06. MAAS was found to have high internal consistency (Cronbach's α = 0.90) and adequate test-retest reliability at a 1-2 week interval (ICC = 0.90). It showed significant and expected correlations with the criterion measures with the exception of the Euroqol (Pearson = 0.15). Psychometric properties of the Spanish version of the MAAS in patients with FM are adequate. The dimensionality of the MAAS found in this sample and directions for future research are discussed.

Evaluation and Enhancement of Calibration in the American College of Surgeons NSQIP Surgical Risk Calculator.

PubMed

Liu, Yaoming; Cohen, Mark E; Hall, Bruce L; Ko, Clifford Y; Bilimoria, Karl Y

2016-08-01

The American College of Surgeon (ACS) NSQIP Surgical Risk Calculator has been widely adopted as a decision aid and informed consent tool by surgeons and patients. Previous evaluations showed excellent discrimination and combined discrimination and calibration, but model calibration alone, and potential benefits of recalibration, were not explored. Because lack of calibration can lead to systematic errors in assessing surgical risk, our objective was to assess calibration and determine whether spline-based adjustments could improve it. We evaluated Surgical Risk Calculator model calibration, as well as discrimination, for each of 11 outcomes modeled from nearly 3 million patients (2010 to 2014). Using independent random subsets of data, we evaluated model performance for the Development (60% of records), Validation (20%), and Test (20%) datasets, where prediction equations from the Development dataset were recalibrated using restricted cubic splines estimated from the Validation dataset. We also evaluated performance on data subsets composed of higher-risk operations. The nonrecalibrated Surgical Risk Calculator performed well, but there was a slight tendency for predicted risk to be overestimated for lowest- and highest-risk patients and underestimated for moderate-risk patients. After recalibration, this distortion was eliminated, and p values for miscalibration were most often nonsignificant. Calibration was also excellent for subsets of higher-risk operations, though observed calibration was reduced due to instability associated with smaller sample sizes. Performance of NSQIP Surgical Risk Calculator models was shown to be excellent and improved with recalibration. Surgeons and patients can rely on the calculator to provide accurate estimates of surgical risk. Copyright © 2016 American College of Surgeons. Published by Elsevier Inc. All rights reserved.

Dermatoglyphic features in patients with multiple sclerosis

PubMed Central

Sabanciogullari, Vedat; Cevik, Seyda; Karacan, Kezban; Bolayir, Ertugrul; Cimen, Mehmet

2014-01-01

Objective: To examine dermatoglyphic features to clarify implicated genetic predisposition in the etiology of multiple sclerosis (MS). Methods: The study was conducted between January and December 2013 in the Departments of Anatomy, and Neurology, Cumhuriyet University School of Medicine, Sivas, Turkey. The dermatoglyphic data of 61 patients, and a control group consisting of 62 healthy adults obtained with a digital scanner were transferred to a computer environment. The ImageJ program was used, and atd, dat, adt angles, a-b ridge count, sample types of all fingers, and ridge counts were calculated. Results: In both hands of the patients with MS, the a-b ridge count and ridge counts in all fingers increased, and the differences in these values were statistically significant. There was also a statistically significant increase in the dat angle in both hands of the MS patients. On the contrary, there was no statistically significant difference between the groups in terms of dermal ridge samples, and the most frequent sample in both groups was the ulnar loop. Conclusions: Aberrations in the distribution of dermatoglyphic samples support the genetic predisposition in MS etiology. Multiple sclerosis susceptible individuals may be determined by analyzing dermatoglyphic samples. PMID:25274586

Experiential Teaching Increases Medication Calculation Accuracy Among Baccalaureate Nursing Students.

PubMed

Hurley, Teresa V

Safe medication administration is an international goal. Calculation errors cause patient harm despite education. The research purpose was to evaluate the effectiveness of an experiential teaching strategy to reduce errors in a sample of 78 baccalaureate nursing students at a Northeastern college. A pretest-posttest design with random assignment into equal-sized groups was used. The experiential strategy was more effective than the traditional method (t = -0.312, df = 37, p = .004, 95% CI) with a reduction in calculation errors. Evaluations of error type and teaching strategies are indicated to facilitate course and program changes.

Single-sample 99mTc-diethylenetriamine penta-acetate plasma clearance in advanced renal failure by the mean sojourn time approach.

PubMed

Gref, Margareta C; Karp, Kjell H

2009-03-01

The single-sample Tc-diethylenetriamine penta-acetate (DTPA) clearance method by Christensen and Groth is recommended by the Radionuclides in Nephrourology Committee on Renal Clearance for use in adults with an estimated glomerular filtration rate (GFR) > or = 30 ml/min. The purpose of this study was to test a new Tc-DTPA single-sample low clearance formula for GFR lesser than 30 ml/min. Twenty-one adult patients (29 investigations) were included. Reference clearance was calculated with both Cr-EDTA and Tc-DTPA according to Brøchner-Mortensen with samples drawn between 3 and 24 h. Single-sample clearance was calculated from a 24 h sample using the low clearance formula(Equation is included in full-text article.) C(t) is the activity of the tracer in the plasma sample t minutes after the injection and Q0 is the injected amount. ECV is the extracellular volume in ml defined as the distribution volume of the tracer. ECV is estimated from the body surface area as ECV=8116.6xbody surface area-28.2. The mean difference between reference and Tc-DTPA single-sample clearance was -0.5 ml/min (SD 1.0 ml/min) for Tc-DTPA and -0.8 ml/min (SD 1.2 ml/min) for Cr-EDTA as reference clearance. In adult patients it is possible, even with GFR lesser than 30 ml/min, to get an accurate determination of Tc-DTPA plasma clearance from a single sample using the mean sojourn time approach. The blood sample should be obtained about 24 h after injection of the GFR tracer.

Novel joint selection methods can reduce sample size for rheumatoid arthritis clinical trials with ultrasound endpoints.

PubMed

Allen, John C; Thumboo, Julian; Lye, Weng Kit; Conaghan, Philip G; Chew, Li-Ching; Tan, York Kiat

2018-03-01

To determine whether novel methods of selecting joints through (i) ultrasonography (individualized-ultrasound [IUS] method), or (ii) ultrasonography and clinical examination (individualized-composite-ultrasound [ICUS] method) translate into smaller rheumatoid arthritis (RA) clinical trial sample sizes when compared to existing methods utilizing predetermined joint sites for ultrasonography. Cohen's effect size (ES) was estimated (ES^) and a 95% CI (ES^L, ES^U) calculated on a mean change in 3-month total inflammatory score for each method. Corresponding 95% CIs [nL(ES^U), nU(ES^L)] were obtained on a post hoc sample size reflecting the uncertainty in ES^. Sample size calculations were based on a one-sample t-test as the patient numbers needed to provide 80% power at α = 0.05 to reject a null hypothesis H 0 : ES = 0 versus alternative hypotheses H 1 : ES = ES^, ES = ES^L and ES = ES^U. We aimed to provide point and interval estimates on projected sample sizes for future studies reflecting the uncertainty in our study ES^S. Twenty-four treated RA patients were followed up for 3 months. Utilizing the 12-joint approach and existing methods, the post hoc sample size (95% CI) was 22 (10-245). Corresponding sample sizes using ICUS and IUS were 11 (7-40) and 11 (6-38), respectively. Utilizing a seven-joint approach, the corresponding sample sizes using ICUS and IUS methods were nine (6-24) and 11 (6-35), respectively. Our pilot study suggests that sample size for RA clinical trials with ultrasound endpoints may be reduced using the novel methods, providing justification for larger studies to confirm these observations. © 2017 Asia Pacific League of Associations for Rheumatology and John Wiley & Sons Australia, Ltd.

Kinetic modeling of PET-FDG in the brain without blood sampling.

PubMed

Bentourkia, M'hamed

2006-12-01

The aim in this work is to report a new method to calculate parametric images from a single scan acquisition with positron emission tomography (PET) and fluorodeoxyglucose (FDG) in the human brain without blood sampling. It is usually practical for research or clinical purposes to inject the patient in an isolated room and to start the PET acquisition only for some 10-20 min, about 30 min after FDG injection. In order to calculate the cerebral metabolic rates for glucose (CMRG), usually several blood samples are required. The proposed method considers the relation between the uptake of the tracer in the cerebellum as a reference tissue and the population based input curve. Similar results were obtained for CMRG values with the present method in comparison to the usual autoradiographic and the non-linear least squares fitting of regions of interest.

(Not) talking about sex: a systematic comparison of sexual impairment in women with systemic sclerosis and other chronic disease samples.

PubMed

Knafo, Ruby; Thombs, Brett D; Jewett, Lisa; Hudson, Marie; Wigley, Fred; Haythornthwaite, Jennifer A

2009-10-01

Sexual impairment in women with SSc has received little attention. The objective of this study was to compare levels of sexual impairment in women with SSc with samples of women with medical illnesses for which sexual impairment has been researched more extensively. SSc patients completed the Sexual Relationships subscale of the Psychosocial Adjustment to Illness Scale-Self-Report (PAIS-SR). A systematic review was conducted to select comparison samples. Sexual Relationships subscale scores from SSc patients were compared with scores from comparison samples (breast or gynaecological cancer and HIV) using t-tests and Hedges's g to calculate effect sizes. Samples from 138 female SSc patients were analysed (28.3% diffuse; mean age 52.1 +/- 12.3 years; mean time since diagnosis 9.0 +/- 8.3 years). Women with dcSSc (6.1 +/- 4.2) reported significantly greater sexual impairment (P < 0.05) than those with lcSSc (4.4 +/- 4.2), three breast cancer samples (1.8 +/- 0.1, 3.4 +/- 3.9, 1.6 +/- 0.6) and two samples of HIV-positive female patients (4.4 +/- 3.8, 4.5 +/- 3.9). Scores in dcSSc were similar to one sample of HIV-positive women (5.8 +/- 4.1) and gynaecological cancer patients (7.3 +/- 4.3). Scores in lcSSc were significantly higher than two breast cancer samples, similar to one breast cancer sample and two HIV-positive samples, and significantly lower (P < 0.05) than in one HIV sample and gynaecological cancer. Women with SSc, particularly those with dcSSc, have high levels of sexual impairment compared with women with other chronic diseases, where sexual function has received greater attention. Further research is needed on sexual function among women with SSc.

Clinical Validation of Therapeutic Drug Monitoring of Imipenem in Spent Effluent in Critically Ill Patients Receiving Continuous Renal Replacement Therapy: A Pilot Study.

PubMed

Wen, Aiping; Li, Zhe; Yu, Junxian; Li, Ren; Cheng, Sheng; Duan, Meili; Bai, Jing

2016-01-01

The primary objective of this pilot study was to investigate whether the therapeutic drug monitoring of imipenem could be performed with spent effluent instead of blood sampling collected from critically ill patients under continuous renal replacement therapy. A prospective open-label study was conducted in a real clinical setting. Both blood and effluent samples were collected pairwise before imipenem administration and 0.5, 1, 1.5, 2, 3, 4, 6, and 8 h after imipenem administration. Plasma and effluent imipenem concentrations were determined by reversed-phase high-performance liquid chromatography with ultraviolet detection. Pharmacokinetic and pharmacodynamic parameters of blood and effluent samples were calculated. Eighty-three paired plasma and effluent samples were obtained from 10 patients. The Pearson correlation coefficient of the imipenem concentrations in plasma and effluent was 0.950 (P<0.0001). The average plasma-to-effluent imipenem concentration ratio was 1.044 (95% confidence interval, 0.975 to 1.114) with Bland-Altman analysis. No statistically significant difference was found in the pharmacokinetic and pharmacodynamic parameters tested in paired plasma and effluent samples with Wilcoxon test. Spent effluent of continuous renal replacement therapy could be used for therapeutic drug monitoring of imipenem instead of blood sampling in critically ill patients.

Correlation between systolic transvalvular flow and proximal aortic wall changes in bicuspid aortic valve stenosis.

PubMed

Girdauskas, Evaldas; Rouman, Mina; Disha, Kushtrim; Scholle, Thorsten; Fey, Beatrix; Theis, Bernhard; Petersen, Iver; Borger, Michael A; Kuntze, Thomas

2014-08-01

The purpose of this study was to analyse the correlation between preoperative systolic transvalvular flow patterns and proximal aortic wall lesions in patients undergoing surgery for bicuspid aortic valve (BAV) stenosis. A total of 48 consecutive patients with BAV stenosis (mean age 58 ± 9 years, 65% male) underwent aortic valve replacement (AVR) ± proximal aortic surgery from January 2012 through February 2013. Preoperative cardiac phase-contrast cine magnetic resonance imaging (MRI) assessment was performed in all patients in order to detect the area of maximal flow-induced stress in the proximal aorta. Based on these MRI data, two aortic wall samples (i.e. area of the maximal stress (jet sample) and the opposite aortic wall (control sample)) were collected during AVR surgery. Aortic wall changes were graded based on a summation of seven histological criteria (each scored from 0 to 3). Histological sum score (0-21) was separately calculated and compared between the two aortic samples (i.e. jet sample vs control sample). An eccentric transvalvular flow jet hitting the proximal aortic wall could be identified in all 48 (100%) patients. The mean histological sum score was significantly higher in the jet sample vs control sample areas of the aorta (i.e. 4.1 ± 1.8 vs 2.2 ± 1.5, respectively) (P = 0.02). None of the patients had a higher sum score value in the control sample. Our study demonstrates a strong correlation between the systolic pattern of the transvalvular flow jet and asymmetric proximal aortic wall changes in patients undergoing AVR for BAV stenosis. © The Author 2014. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

Can Palliative Home Care Reduce 30-Day Readmissions? Results of a Propensity Score Matched Cohort Study

PubMed Central

Ranganathan, Anjana; Dougherty, Meredith; Waite, David

2013-01-01

Abstract Objective This study examined the impact of palliative home nursing care on rates of hospital 30-day readmissions. Methods The electronic health record based retrospective cohort study was performed within home care and palliative home care programs. Participants were home care patients discharged from one of three urban teaching hospitals. Outcome measures were propensity score matched rates of hospital readmissions within 30 days of hospital discharge. Results Of 406 palliative home care patients, matches were identified for 392 (96%). Of 15,709 home care patients, 890 were used at least once as a match for palliative care patients, for a total final sample of 1282. Using the matched sample we calculated the average treatment effect for treated patients. In this sample, palliative care patients had a 30-day readmission probability of 9.1% compared to a probability of 17.4% in the home care group (mean ATT: 8.3%; 95% confidence interval [CI] 8.0%–8.6%). This effect persisted after adjustment for visit frequency. Conclusions Palliative home care may offer benefits to health systems by allowing patients to remain at home and thereby avoiding 30-day rehospitalizations. PMID:24007348

Factors associated to acceptable treatment adherence among children with chronic kidney disease in Guatemala

PubMed Central

Cerón, Alejandro; Méndez-Alburez, Luis Pablo; Lou-Meda, Randall

2017-01-01

Pediatric patients with Chronic Kidney Disease face several barriers to medication adherence that, if addressed, may improve clinical care outcomes. A cross sectional questionnaire was administered in the Foundation for Children with Kidney Disease (FUNDANIER, Guatemala City) from September of 2015 to April of 2016 to identify the predisposing factors, enabling factors and need factors related to medication adherence. Sample size was calculated using simple random sampling with a confidence level of 95%, confidence interval of 0.05 and a proportion of 87%. A total of 103 participants responded to the questionnaire (calculated sample size was 96). Independent variables were defined and described, and the bivariate relationship to dependent variables was determined using Odds Ratio. Multivariate analysis was carried out using logistic regression. The mean adherence of study population was 78% (SD 0.08, max = 96%, min = 55%). The mean adherence in transplant patients was 82% (SD 7.8, max 96%, min 63%), and the mean adherence in dialysis patients was 76% (SD 7.8 max 90%, min 55%). Adherence was positively associated to the mother’s educational level and to higher monthly household income. Together predisposing, enabling and need factors illustrate the complexities surrounding adherence in this pediatric CKD population. Public policy strategies aimed at improving access to comprehensive treatment regimens may facilitate treatment access, alleviating economic strain on caregivers and may improve adherence outcomes. PMID:29036228

Factors associated to acceptable treatment adherence among children with chronic kidney disease in Guatemala.

PubMed

Ramay, Brooke M; Cerón, Alejandro; Méndez-Alburez, Luis Pablo; Lou-Meda, Randall

2017-01-01

Pediatric patients with Chronic Kidney Disease face several barriers to medication adherence that, if addressed, may improve clinical care outcomes. A cross sectional questionnaire was administered in the Foundation for Children with Kidney Disease (FUNDANIER, Guatemala City) from September of 2015 to April of 2016 to identify the predisposing factors, enabling factors and need factors related to medication adherence. Sample size was calculated using simple random sampling with a confidence level of 95%, confidence interval of 0.05 and a proportion of 87%. A total of 103 participants responded to the questionnaire (calculated sample size was 96). Independent variables were defined and described, and the bivariate relationship to dependent variables was determined using Odds Ratio. Multivariate analysis was carried out using logistic regression. The mean adherence of study population was 78% (SD 0.08, max = 96%, min = 55%). The mean adherence in transplant patients was 82% (SD 7.8, max 96%, min 63%), and the mean adherence in dialysis patients was 76% (SD 7.8 max 90%, min 55%). Adherence was positively associated to the mother's educational level and to higher monthly household income. Together predisposing, enabling and need factors illustrate the complexities surrounding adherence in this pediatric CKD population. Public policy strategies aimed at improving access to comprehensive treatment regimens may facilitate treatment access, alleviating economic strain on caregivers and may improve adherence outcomes.

Independent Monte-Carlo dose calculation for MLC based CyberKnife radiotherapy

NASA Astrophysics Data System (ADS)

Mackeprang, P.-H.; Vuong, D.; Volken, W.; Henzen, D.; Schmidhalter, D.; Malthaner, M.; Mueller, S.; Frei, D.; Stampanoni, M. F. M.; Dal Pra, A.; Aebersold, D. M.; Fix, M. K.; Manser, P.

2018-01-01

This work aims to develop, implement and validate a Monte Carlo (MC)-based independent dose calculation (IDC) framework to perform patient-specific quality assurance (QA) for multi-leaf collimator (MLC)-based CyberKnife® (Accuray Inc., Sunnyvale, CA) treatment plans. The IDC framework uses an XML-format treatment plan as exported from the treatment planning system (TPS) and DICOM format patient CT data, an MC beam model using phase spaces, CyberKnife MLC beam modifier transport using the EGS++ class library, a beam sampling and coordinate transformation engine and dose scoring using DOSXYZnrc. The framework is validated against dose profiles and depth dose curves of single beams with varying field sizes in a water tank in units of cGy/Monitor Unit and against a 2D dose distribution of a full prostate treatment plan measured with Gafchromic EBT3 (Ashland Advanced Materials, Bridgewater, NJ) film in a homogeneous water-equivalent slab phantom. The film measurement is compared to IDC results by gamma analysis using 2% (global)/2 mm criteria. Further, the dose distribution of the clinical treatment plan in the patient CT is compared to TPS calculation by gamma analysis using the same criteria. Dose profiles from IDC calculation in a homogeneous water phantom agree within 2.3% of the global max dose or 1 mm distance to agreement to measurements for all except the smallest field size. Comparing the film measurement to calculated dose, 99.9% of all voxels pass gamma analysis, comparing dose calculated by the IDC framework to TPS calculated dose for the clinical prostate plan shows 99.0% passing rate. IDC calculated dose is found to be up to 5.6% lower than dose calculated by the TPS in this case near metal fiducial markers. An MC-based modular IDC framework was successfully developed, implemented and validated against measurements and is now available to perform patient-specific QA by IDC.

Sample entropy applied to the analysis of synthetic time series and tachograms

NASA Astrophysics Data System (ADS)

Muñoz-Diosdado, A.; Gálvez-Coyt, G. G.; Solís-Montufar, E.

2017-01-01

Entropy is a method of non-linear analysis that allows an estimate of the irregularity of a system, however, there are different types of computational entropy that were considered and tested in order to obtain one that would give an index of signals complexity taking into account the data number of the analysed time series, the computational resources demanded by the method, and the accuracy of the calculation. An algorithm for the generation of fractal time-series with a certain value of β was used for the characterization of the different entropy algorithms. We obtained a significant variation for most of the algorithms in terms of the series size, which could result counterproductive for the study of real signals of different lengths. The chosen method was sample entropy, which shows great independence of the series size. With this method, time series of heart interbeat intervals or tachograms of healthy subjects and patients with congestive heart failure were analysed. The calculation of sample entropy was carried out for 24-hour tachograms and time subseries of 6-hours for sleepiness and wakefulness. The comparison between the two populations shows a significant difference that is accentuated when the patient is sleeping.

Phase II Trials for Heterogeneous Patient Populations with a Time-to-Event Endpoint.

PubMed

Jung, Sin-Ho

2017-07-01

In this paper, we consider a single-arm phase II trial with a time-to-event end-point. We assume that the study population has multiple subpopulations with different prognosis, but the study treatment is expected to be similarly efficacious across the subpopulations. We review a stratified one-sample log-rank test and present its sample size calculation method under some practical design settings. Our sample size method requires specification of the prevalence of subpopulations. We observe that the power of the resulting sample size is not very sensitive to misspecification of the prevalence.

Calculating the refractive index for pediatric parenteral nutrient solutions.

PubMed

Nelson, Scott; Barrows, Jason; Haftmann, Richard; Helm, Michael; MacKay, Mark

2013-02-15

The utility of refractometric analysis for calculating the refractive index (RI) of compounded parenteral nutrient solutions for pediatric patients was examined. An equation for calculating the RI of parenteral nutrient solutions was developed by chemical and linear regression analysis of 154 pediatric parenteral nutrient solutions. This equation was then validated by analyzing 1057 pediatric parenteral nutrition samples. The RI for the parenteral nutrient solutions could be calculated by summing the RI contribution for each ingredient and then adding the RI of water. The RI contribution for each ingredient was determined by multiplying the RI of the manufacturer's concentrate by the volume of the manufacturer's concentrate mixed into the parenteral nutrient solution divided by the total volume of the parenteral nutrient solution. The calculated RI was highly correlated with the measured RI (R(2) = 0.94, p < 0.0001). Using a range of two standard deviations (±0.0045), 99.8% of the samples fell into the comparative range. RIs of electrolytes, vitamins, and trace elements in the concentrations used did not affect the RI, similar to the findings of other studies. There was no statistical difference between the calculated RI and the measured RI in the final product of a pediatric parenteral nutrient solution. This method of quality control can be used by personnel compounding parenteral nutrient solutions to confirm the compounding accuracy of dextrose and amino acid concentrations in the final product, and a sample can be sent to the hospital laboratory for electrolyte verification.

Mapping the EORTC QLQ-C30 onto the EQ-5D-3L: assessing the external validity of existing mapping algorithms.

PubMed

Doble, Brett; Lorgelly, Paula

2016-04-01

To determine the external validity of existing mapping algorithms for predicting EQ-5D-3L utility values from EORTC QLQ-C30 responses and to establish their generalizability in different types of cancer. A main analysis (pooled) sample of 3560 observations (1727 patients) and two disease severity patient samples (496 and 93 patients) with repeated observations over time from Cancer 2015 were used to validate the existing algorithms. Errors were calculated between observed and predicted EQ-5D-3L utility values using a single pooled sample and ten pooled tumour type-specific samples. Predictive accuracy was assessed using mean absolute error (MAE) and standardized root-mean-squared error (RMSE). The association between observed and predicted EQ-5D utility values and other covariates across the distribution was tested using quantile regression. Quality-adjusted life years (QALYs) were calculated using observed and predicted values to test responsiveness. Ten 'preferred' mapping algorithms were identified. Two algorithms estimated via response mapping and ordinary least-squares regression using dummy variables performed well on number of validation criteria, including accurate prediction of the best and worst QLQ-C30 health states, predicted values within the EQ-5D tariff range, relatively small MAEs and RMSEs, and minimal differences between estimated QALYs. Comparison of predictive accuracy across ten tumour type-specific samples highlighted that algorithms are relatively insensitive to grouping by tumour type and affected more by differences in disease severity. Two of the 'preferred' mapping algorithms suggest more accurate predictions, but limitations exist. We recommend extensive scenario analyses if mapped utilities are used in cost-utility analyses.

Predicted versus observed 30-day perioperative outcomes using the ACS NSQIP surgical risk calculator in patients undergoing partial nephrectomy for renal cell carcinoma.

PubMed

Blair, Brian M; Lehman, Erik B; Jafri, Syed M; Kaag, Matthew G; Raman, Jay D

2018-06-04

The purpose of the study was to evaluate the accuracy of the American College of Surgeons NSQIP Surgical Risk Calculator for predicting risk-adjusted 30-day outcomes for patients undergoing partial nephrectomy (PN) for renal cell carcinoma (RCC). A single institution, multi-surgeon, prospectively maintained database was queried for patients undergoing PN for RCC from 1998 to 2015. 21 preoperative factors were analyzed for each patient with predicted risk for 30-day complications, mortality, and length of stay (LOS) calculated. Differences between the mean predicted risk and observed rate of surgical outcomes were determined using two-sided one-sample t test with significance at p < 0.05. Subgroup analyses of outcomes stratified by surgical approach were also performed. 470 patients undergoing PN for RCC were analyzed. Comparing NSQIP predicted to observed outcomes, clinically significant underestimations occurred with rates of overall complications (9.16 vs. 16.81%, p < 0.001), surgical site infections [SSI] (1.65 vs. 2.77%, p < 0.001), urinary tract infection [UTI] (1.41 vs. 3.40%, p < 0.001), and LOS (3.25 vs. 3.73 days, p < 0.001). On subgroup analysis, 209 open PN and 261 minimally invasive PN (MIPN) were performed. The NSQIP calculator consistently underestimated overall complications, SSI, UTI, and LOS (p < 0.001) among both surgical approaches, while overestimating MIPN severe complications (p < 0.001). Clinically important differences persisted when stratifying the MIPN group by laparoscopic (N = 111) and robotic (N = 150) approaches. The ACS NSQIP Surgical Risk Calculator had significant discrepancies among observed and predicted outcomes. Additional analyses confirmed these differences remained significant irrespective of surgical approach. These findings emphasize the need for urologic oncology-specific calculators to better predict surgical outcomes in this complex patient population.

Gender-partitioned patient medians of serum albumin requested by general practitioners for the assessment of analytical stability.

PubMed

Hansen, Steen Ingemann; Petersen, Per Hyltoft; Lund, Flemming; Fraser, Callum G; Sölétormos, György

2018-04-25

Recently, the use of separate gender-partitioned patient medians of serum sodium has revealed potential for monitoring analytical stability within the optimum analytical performance specifications for laboratory medicine. The serum albumin concentration depends on whether a patient is sitting or recumbent during phlebotomy. We therefore investigated only examinations requested by general practitioners (GPs) to provide data from sitting patients. Weekly and monthly patient medians of serum albumin requested by GP for both male and female patients were calculated from the raw data obtained from three analysers in the hospital laboratory on examination of samples from those >18 years. The half-range of medians were applied as an estimate of the maximum bias. Further, the ratios between the two medians were calculated (females/males). The medians for male and female patients were closely related despite considerable variation due to the current analytical variation. This relationship was confirmed by the calculated half-range for the monthly ratio between the genders of 0.44%, which surpasses the optimum analytical performance specification for bias of serum albumin (0.72%). The weekly ratio had a half-range of 1.83%, which surpasses the minimum analytical performance specifications of 2.15%. Monthly gender-partitioned patient medians of serum albumin are useful for monitoring of long-term analytical stability, where the gender medians are two independent estimates of changes in (delta) bias: only results requested by GP are of value in this application to ensure that all patients are sitting during phlebotomy.

Biodosimetry of heavy ions by interphase chromosome painting

NASA Astrophysics Data System (ADS)

Durante, M.; Kawata, T.; Nakano, T.; Yamada, S.; Tsujii, H.

1998-11-01

We report measurements of chromosomal aberrations in peripheral blood lymphocytes from cancer patients undergoing radiotherapy treatment. Patients with cervix or esophageal cancer were treated with 10 MV X-rays produced at a LINAC accelerator, or high-energy carbon ions produced at the HIMAC accelerator at the National Institute for Radiological Sciences (NIRS) in Chiba. Blood samples were obtained before, during, and after the radiation treatment. Chromosomes were prematurely condensed by incubation in calyculin A. Aberrations in chromosomes 2 and 4 were scored after fluorescence in situ hybridization with whole-chromosome probes. Pre-treatment samples were exposed in vitro to X-rays, individual dose-response curves for the induction of chromosomal aberrations were determined, and used as calibration curves to calculate the effective whole-body dose absorbed during the treatment. This calculated dose, based on the calibration curve relative to the induction of reciprocal exchanges, has a sharp increase after the first few fractions of the treatment, then saturates at high doses. Although carbon ions are 2-3 times more effective than X-rays in tumor sterilization, the effective dose was similar to that of X-ray treatment. However, the frequency of complex-type chromosomal exchanges was much higher for patients treated with carbon ions than X-ray.

Psychometric properties of the Spanish version of the mindful attention awareness scale (MAAS) in patients with fibromyalgia

PubMed Central

2013-01-01

Background Mindful-based interventions improve functioning and quality of life in fibromyalgia (FM) patients. The aim of the study is to perform a psychometric analysis of the Spanish version of the Mindful Attention Awareness Scale (MAAS) in a sample of patients diagnosed with FM. Methods The following measures were administered to 251 Spanish patients with FM: the Spanish version of MAAS, the Chronic Pain Acceptance Questionnaire, the Pain Catastrophising Scale, the Injustice Experience Questionnaire, the Psychological Inflexibility in Pain Scale, the Fibromyalgia Impact Questionnaire and the Euroqol. Factorial structure was analysed using Confirmatory Factor Analyses (CFA). Cronbach's α coefficient was calculated to examine internal consistency, and the intraclass correlation coefficient (ICC) was calculated to assess the test-retest reliability of the measures. Pearson’s correlation tests were run to evaluate univariate relationships between scores on the MAAS and criterion variables. Results The MAAS scores in our sample were low (M = 56.7; SD = 17.5). CFA confirmed a two-factor structure, with the following fit indices [sbX2 = 172.34 (p < 0.001), CFI = 0.95, GFI = 0.90, SRMR = 0.05, RMSEA = 0.06. MAAS was found to have high internal consistency (Cronbach’s α = 0.90) and adequate test-retest reliability at a 1–2 week interval (ICC = 0.90). It showed significant and expected correlations with the criterion measures with the exception of the Euroqol (Pearson = 0.15). Conclusion Psychometric properties of the Spanish version of the MAAS in patients with FM are adequate. The dimensionality of the MAAS found in this sample and directions for future research are discussed. PMID:23317306

Serum Ropivacaine Concentrations and Systemic Local Anesthetic Toxicity in Trauma Patients Receiving Long-Term Continuous Peripheral Nerve Block Catheters

DTIC Science & Technology

2010-02-01

concentrations were calculated from the following 2 methods: 1. Using peak area ratio of ropivacaine/ bupivacaine of samples versus peak area ratio of...ropivacaine/ bupivacaine of standards (0–3000 ng/mL) using the following formula: RopS (PA of Rop)/(PA of Bup)S /(PA of Rop)/(PA of Bup)STD Bup...1/mL serum used) where Rop ropivacaine, Bup bupivacaine , PA peak area, S sample, and STD standard. 2. Samples of ropivacaine concentrations

Third-space fluid distribution of pemetrexed in non-small cell lung cancer patients.

PubMed

Honoré, Per Hartvig; Joensen, Sigrid Jóhansdóttir; Olsen, Michelle; Hansen, Steen Honoré; Mellemgaard, Anders

2014-08-01

Hydrophilic drugs particularly those with low plasma protein binding may accumulate in third-space fluid in the body. Cytotoxic drugs like methotrexate (MTX) cause damage in the tissue, and evacuation of the third-space fluid in pleura is strongly recommended before new dosing. Pemetrexed (PEM) is a multi-targeted antifolate similar to MTX approved for the treatment for malignant pleural mesothelioma and non-small cell lung cancer. Current recommendations for patients receiving treatment with PEM prescribe draining of the pleural fluid. This is based upon the recommendations for MTX and not directly to any specific findings relating to PEM. The recommendations are the same because PEM is an analogue of MTX; the molecular structures and pharmacokinetic parameters are similar. However, since draining the pleural fluid is painful and cancer patient are particularly susceptible to infection subsequently, it is relevant to examine the recommendations for PEM explicitly. Eight patients treated with a 500 mg/m(2) PEM combined with platinum salt were examined. Plasma samples were first collected in relation to the start of PEM infusion. Thereafter, plasma and pleura samples were taken at various times after drug infusion from each patient; in two patients, sampling was done twice but on different occasions. The quantitative determination of PEM was performed with reversed-phase high-performance liquid chromatography, and sample preparation was performed using protein precipitation with perchloric acid. Pharmacokinetic analysis was performed using a non-compartment method as well a two-compartment model. The results were calculated from 10 samples taken from eight patients, where data from one patient point were excluded as the patient had impaired renal function, and three samples were reported as below limit of quantification. The plasma PEM pharmacokinetics calculated showed an elimination half-life (t ½ elimination) of 3.2 h and distribution half-life (t ½-distribution) of 6 min. Clearance (CL) was 5.1 L/h, central volume of distribution (V(central)) 23.2 L and peripheral volume distribution (V(peripheral)) 10.6 L, and the area under the curve was 186 μg h/mL. Using non-compartment methods, an elimination half-life of 3.1 h and an apparent CL of 3.2 L/h were measured, whereas an apparent steady-state volume became 14.2 L. The pleura concentrations were only half of simultaneous plasma concentrations, and elimination half-life was 3.15 h. Pemetrexed is not likely to accumulate in the pleural fluid, and evacuation of fluid might not be necessary. Further investigation is needed to recommend no drainage of the fluid, i.e., in patients with renal impairment.

A Possible Application of Coherent Light Scattering on Biological Fluids

NASA Astrophysics Data System (ADS)

Chicea, Dan; Chicea, Liana Maria

2007-04-01

Human urine from both healthy patients and patients with different diseases was used as scattering medium in a coherent light scattering experiment. The time variation of the light intensity in the far field speckle image was acquired using a data acquisition system on a PC and a time series resulted for each sample. The autocorrelation function for each sample was calculated and the autocorrelation time was determined. The same samples were analyzed in a medical laboratory using the standard procedure. We found so far that the autocorrelation time is differently modified by the presence of pus, albumin, urobilin and sediments. The results suggest a fast procedure that can be used as laboratory test to detect the presence not of each individual component in suspensions but of big conglomerates as albumin, cylinders, oxalate crystals.

Small studies may overestimate the effect sizes in critical care meta-analyses: a meta-epidemiological study

PubMed Central

2013-01-01

Introduction Small-study effects refer to the fact that trials with limited sample sizes are more likely to report larger beneficial effects than large trials. However, this has never been investigated in critical care medicine. Thus, the present study aimed to examine the presence and extent of small-study effects in critical care medicine. Methods Critical care meta-analyses involving randomized controlled trials and reported mortality as an outcome measure were considered eligible for the study. Component trials were classified as large (≥100 patients per arm) and small (<100 patients per arm) according to their sample sizes. Ratio of odds ratio (ROR) was calculated for each meta-analysis and then RORs were combined using a meta-analytic approach. ROR<1 indicated larger beneficial effect in small trials. Small and large trials were compared in methodological qualities including sequence generating, blinding, allocation concealment, intention to treat and sample size calculation. Results A total of 27 critical care meta-analyses involving 317 trials were included. Of them, five meta-analyses showed statistically significant RORs <1, and other meta-analyses did not reach a statistical significance. Overall, the pooled ROR was 0.60 (95% CI: 0.53 to 0.68); the heterogeneity was moderate with an I2 of 50.3% (chi-squared = 52.30; P = 0.002). Large trials showed significantly better reporting quality than small trials in terms of sequence generating, allocation concealment, blinding, intention to treat, sample size calculation and incomplete follow-up data. Conclusions Small trials are more likely to report larger beneficial effects than large trials in critical care medicine, which could be partly explained by the lower methodological quality in small trials. Caution should be practiced in the interpretation of meta-analyses involving small trials. PMID:23302257

Implementing Generalized Additive Models to Estimate the Expected Value of Sample Information in a Microsimulation Model: Results of Three Case Studies.

PubMed

Rabideau, Dustin J; Pei, Pamela P; Walensky, Rochelle P; Zheng, Amy; Parker, Robert A

2018-02-01

The expected value of sample information (EVSI) can help prioritize research but its application is hampered by computational infeasibility, especially for complex models. We investigated an approach by Strong and colleagues to estimate EVSI by applying generalized additive models (GAM) to results generated from a probabilistic sensitivity analysis (PSA). For 3 potential HIV prevention and treatment strategies, we estimated life expectancy and lifetime costs using the Cost-effectiveness of Preventing AIDS Complications (CEPAC) model, a complex patient-level microsimulation model of HIV progression. We fitted a GAM-a flexible regression model that estimates the functional form as part of the model fitting process-to the incremental net monetary benefits obtained from the CEPAC PSA. For each case study, we calculated the expected value of partial perfect information (EVPPI) using both the conventional nested Monte Carlo approach and the GAM approach. EVSI was calculated using the GAM approach. For all 3 case studies, the GAM approach consistently gave similar estimates of EVPPI compared with the conventional approach. The EVSI behaved as expected: it increased and converged to EVPPI for larger sample sizes. For each case study, generating the PSA results for the GAM approach required 3 to 4 days on a shared cluster, after which EVPPI and EVSI across a range of sample sizes were evaluated in minutes. The conventional approach required approximately 5 weeks for the EVPPI calculation alone. Estimating EVSI using the GAM approach with results from a PSA dramatically reduced the time required to conduct a computationally intense project, which would otherwise have been impractical. Using the GAM approach, we can efficiently provide policy makers with EVSI estimates, even for complex patient-level microsimulation models.

Sample Size Requirements and Study Duration for Testing Main Effects and Interactions in Completely Randomized Factorial Designs When Time to Event is the Outcome

PubMed Central

Moser, Barry Kurt; Halabi, Susan

2013-01-01

In this paper we develop the methodology for designing clinical trials with any factorial arrangement when the primary outcome is time to event. We provide a matrix formulation for calculating the sample size and study duration necessary to test any effect with a pre-specified type I error rate and power. Assuming that a time to event follows an exponential distribution, we describe the relationships between the effect size, the power, and the sample size. We present examples for illustration purposes. We provide a simulation study to verify the numerical calculations of the expected number of events and the duration of the trial. The change in the power produced by a reduced number of observations or by accruing no patients to certain factorial combinations is also described. PMID:25530661

Psychometric Properties of the Folstein Mini-Mental State Examination

ERIC Educational Resources Information Center

Lopez, Michael N.; Charter, Richard A.; Mostafavi, Beeta; Nibut, Lorraine P.; Smith, Whitney E.

2005-01-01

Criterion-referenced (Livingston) and norm-referenced (Gilmer-Feldt) techniques were used to measure the internal consistency reliability of Folsteins Mini-Mental State Examination (MMSE) on a large sample (N = 418) of elderly medical patients. Two administration and scoring variants of the MMSE Attention and Calculation section (Serial 7s only…

Estimation of true serum thyroglobulin concentration using simultaneous measurement of serum antithyroglobulin antibody.

PubMed

Ahn, Byeong-Cheol; Lee, Won Kee; Jeong, Shin Young; Lee, Sang-Woo; Lee, Jaetae

2013-01-01

We investigated the analytical interference of antithyroglobulin antibody (TgAb) to thyroglobulin (Tg) measurement and tried to convert measured Tg concentration to true Tg concentration using a mathematical equation which includes a concentration of TgAb. Methods. Tg was measured by immunoradiometric assay and TgAb by radioimmunoassy. Experimental samples were produced by mixing Tg and TgAb standard solutions or mixing patients' serum with high Tg or high TgAb. Mathematical equations for prediction of expected Tg concentration with measured Tg and TgAb concentrations were deduced. The Tg concentration calculated using the equations was compared with the expected Tg concentration. Results. Measured Tg concentrations of samples having high TgAb were significantly lower than their expected Tg concentration. Magnitude of TgAb interference with the Tg assay showed a positive correlation with concentration of TgAb. Mathematical equations for estimation of expected Tg concentration using measured Tg and TgAb concentrations were successfully deduced and the calculated Tg concentration showed excellent correlation with expected Tg concentration. Conclusions. A mathematic equation for estimation of true Tg concentration using measured Tg and TgAb concentration was deduced. Tg concentration calculated by use of the equation might be more valuable than measured Tg concentration in patients with differentiated thyroid cancer.

A randomised trial of sheathed versus standard forceps for obtaining uncontaminated biopsy specimens of microbiota from the terminal ileum.

PubMed

Dave, Maneesh; Johnson, Laura A; Walk, Seth T; Young, Vincent B; Stidham, Ryan W; Chaudhary, Meghana N; Funnell, Jessica; Higgins, Peter D R

2011-08-01

The study of intestinal microbiota has been revolutionised by the use of molecular methods, including terminal restriction fragment length polymorphism (T-RFLP) analysis. Microbiota studies of Crohn's disease patients have examined samples from stool or from the neoterminal ileum with a standard biopsy forceps, which could be contaminated by colonic bacteria when the forceps passes through the colonoscope channel. To determine whether sheathed biopsy forceps are able to obtain terminal ileal microbiota samples with less colonic bacterial contamination compared with unsheathed (standard) biopsy forceps. Prospective randomised single-centre study. Four (paired) biopsy specimens were obtained from adjacent locations in the terminal ileum using the sheathed and standard forceps of 27 consecutive subjects undergoing colonoscopy and the microbiota were characterised using T-RFLP. The Bray-Curtis similarity index between samples (sheathed vs unsheathed forceps) was calculated within patients and significant differences were tested for across all patients. There was not a significant difference in the microbial diversity of samples obtained using sheathed versus unsheathed forceps. The difference in microbial diversity between patients was much greater than the variability within patients by proximal versus distal site or by forceps type. T-RFLP is based on PCR amplification, so it is not always sensitive to rare bacterial species. Standard unsheathed forceps appear to be sufficient for microbiota sample collection from the terminal ileum.

The RBANS Effort Index: base rates in geriatric samples.

PubMed

Duff, Kevin; Spering, Cynthia C; O'Bryant, Sid E; Beglinger, Leigh J; Moser, David J; Bayless, John D; Culp, Kennith R; Mold, James W; Adams, Russell L; Scott, James G

2011-01-01

The Effort Index (EI) of the RBANS was developed to assist clinicians in discriminating patients who demonstrate good effort from those with poor effort. However, there are concerns that older adults might be unfairly penalized by this index, which uses uncorrected raw scores. Using five independent samples of geriatric patients with a broad range of cognitive functioning (e.g., cognitively intact, nursing home residents, probable Alzheimer's disease), base rates of failure on the EI were calculated. In cognitively intact and mildly impaired samples, few older individuals were classified as demonstrating poor effort (e.g., 3% in cognitively intact). However, in the more severely impaired geriatric patients, over one third had EI scores that fell above suggested cutoff scores (e.g., 37% in nursing home residents, 33% in probable Alzheimer's disease). In the cognitively intact sample, older and less educated patients were more likely to have scores suggestive of poor effort. Education effects were observed in three of the four clinical samples. Overall cognitive functioning was significantly correlated with EI scores, with poorer cognition being associated with greater suspicion of low effort. The current results suggest that age, education, and level of cognitive functioning should be taken into consideration when interpreting EI results and that significant caution is warranted when examining EI scores in elders suspected of having dementia.

Efficacy of a strategy for implementing a guideline for the control of cardiovascular risk in a primary healthcare setting: the SIRVA2 study a controlled, blinded community intervention trial randomised by clusters

PubMed Central

2011-01-01

This work describes the methodology used to assess a strategy for implementing clinical practice guidelines (CPG) for cardiovascular risk control in a health area of Madrid. Background The results on clinical practice of introducing CPGs have been little studied in Spain. The strategy used to implement a CPG is known to influence its final use. Strategies based on the involvement of opinion leaders and that are easily executed appear to be among the most successful. Aim The main aim of the present work was to compare the effectiveness of two strategies for implementing a CPG designed to reduce cardiovascular risk in the primary healthcare setting, measured in terms of improvements in the recording of calculated cardiovascular risk or specific risk factors in patients' medical records, the control of cardiovascular risk factors, and the incidence of cardiovascular events. Methods This study involved a controlled, blinded community intervention in which the 21 health centres of the Number 2 Health Area of Madrid were randomly assigned by clusters to be involved in either a proposed CPG implementation strategy to reduce cardiovascular risk, or the normal dissemination strategy. The study subjects were patients ≥ 45 years of age whose health cards showed them to belong to the studied health area. The main variable examined was the proportion of patients whose medical histories included the calculation of their cardiovascular risk or that explicitly mentioned the presence of variables necessary for its calculation. The sample size was calculated for a comparison of proportions with alpha = 0.05 and beta = 0.20, and assuming that the intervention would lead to a 15% increase in the measured variables. Corrections were made for the design effect, assigning a sample size to each cluster proportional to the size of the population served by the corresponding health centre, and assuming losses of 20%. This demanded a final sample size of 620 patients. Data were analysed using summary measures for each cluster, both in making estimates and for hypothesis testing. Analysis of the variables was made on an intention-to-treat basis. Trial Registration ClinicalTrials.gov: NCT01270022 PMID:21504570

Specification and Verification of Medical Monitoring System Using Petri-nets.

PubMed

Majma, Negar; Babamir, Seyed Morteza

2014-07-01

To monitor the patient behavior, data are collected from patient's body by a medical monitoring device so as to calculate the output using embedded software. Incorrect calculations may endanger the patient's life if the software fails to meet the patient's requirements. Accordingly, the veracity of the software behavior is a matter of concern in the medicine; moreover, the data collected from the patient's body are fuzzy. Some methods have already dealt with monitoring the medical monitoring devices; however, model based monitoring fuzzy computations of such devices have been addressed less. The present paper aims to present synthesizing a fuzzy Petri-net (FPN) model to verify behavior of a sample medical monitoring device called continuous infusion insulin (INS) because Petri-net (PN) is one of the formal and visual methods to verify the software's behavior. The device is worn by the diabetic patients and then the software calculates the INS dose and makes a decision for injection. The input and output of the infusion INS software are not crisp in the real world; therefore, we present them in fuzzy variables. Afterwards, we use FPN instead of clear PN to model the fuzzy variables. The paper follows three steps to synthesize an FPN to deal with verification of the infusion INS device: (1) Definition of fuzzy variables, (2) definition of fuzzy rules and (3) design of the FPN model to verify the software behavior.

The impact of drug samples on prescribing to the uninsured.

PubMed

Miller, David P; Mansfield, Richard J; Woods, Jonathan B; Wofford, James L; Moran, William P

2008-09-01

To determine whether drug samples are associated with physicians prescribing fewer generic, less costly medications. We conducted a retrospective study at a large university-affiliated internal medicine practice containing over 70 physicians. Using a pharmacy database, we identified all prescriptions written to uninsured or Medicaid patients that belonged to one of four classes of chronic medications. For the 9 months before and after the clinic closed its drug sample closet, we calculated the percentage of medications prescribed as generics and the mean cost of a 30-day supply of a prescription. Of 8911 prescriptions, 1973 met inclusion criteria. For uninsured patients, the percentage of medications prescribed as generics rose from 12% to 30% after the clinic closed its drug sample closet (P = 0.004). By consecutive three month periods, the percentage of prescribed generic medications rose steadily to a maximum of 40% (P < 0.001). For Medicaid patients, there was no significant change in generic prescribing (63% generic with samples versus 65% generic without samples, P = 0.42). Two factors were associated with generic prescribing in logistic regression: the absence of drug samples (OR 4.54, 95% CI 1.37-15.0) and the prescriber being an attending physician (OR 5.26, 95% CI 2.24-12.4). There was no statistically significant change in cost for either group. Physicians were three times more likely to prescribe generic medications to uninsured patients after drug samples were removed from the office. Drug samples may paradoxically lead to higher costs if physicians with access to samples prescribe more brand-name only drugs.

Impact of different sampling strategies on score results of the Nine Equivalents of Nursing Manpower Use Score (NEMS).

PubMed

Junger, A; Hartmann, B; Klasen, J; Brenck, F; Röhrig, R; Hempelmann, G

2007-01-01

Prospective observational study to assess the impact of two different sampling strategies on the score results of the NEMS, used widely to estimate the amount of nursing workload in an ICU. NEMS scores of all patients admitted to the surgical ICU over a one-year period were automatically calculated twice a day with a patient data management system for each patient day on ICU using two different sampling strategies (NEMS(individual): 24-hour intervals starting from the time of admission; NEMS(8 a.m.): 24-hour intervals starting at 8 a.m.). NEMS(individual) and NEMS(8 a.m.) were collected on 3236 patient days; 687 patients were involved. Significantly lower scores were found for the NEMS(8 a.m.) (25.0 +/- 8.7) compared to the NEMS(individual) (26.1 +/- 8.9, p < 0.01); the interclass correlation coefficient (ICC) was good but not excellent: 0.78. The inter-rater correlation between the two NEMS scores was high or very high (kappa = 0.6-1.0) for six out of nine variables of the NEMS. Different sampling strategies produce different score values, especially due to the end of stay. This has to be taken into account when using the NEMS in quality assurance projects and multi-center studies.

A Randomized Trial of Sheathed vs. Standard Forceps for Obtaining Uncontaminated Biopsy Specimens of Microbiota from the Terminal Ileum

PubMed Central

Dave, Maneesh; Johnson, Laura A.; Walk, Seth; Young, Vincent B.; Stidham, Ryan W.; Chaudhary, Meghana N.; FunNell, Jessica; Higgins, Peter D.R.

2014-01-01

Background The study of intestinal microbiota has been revolutionized by the use of molecular methods, including terminal restriction fragment length polymorphism (T-RFLP) analysis. A number of microbiota studies of Crohn’s disease patients have examined samples from stool or from the neoterminal ileum with a standard biopsy forceps, which could be contaminated by colonic bacteria when the forceps passes through the colonoscope channel. Objective To determine whether sheathed biopsy forceps are able to obtain terminal ileal microbiota samples with less colonic bacterial contamination compared to unsheathed (standard) biopsy forceps. Design Prospective randomized single center-study. Patients and Methods We obtained four (paired) biopsy specimens from adjacent locations in the terminal ileum using the sheathed and standard forceps of 27 consecutive subjects undergoing colonoscopy and characterized the microbiota using T-RFLP. We calculated the Bray Curtis similarity index (BCI) between samples (sheathed vs. unsheathed forceps) within patients and tested for significant differences across all patients. Results There was not a significant difference in the microbial diversity of samples obtained using sheathed vs. unsheathed forceps. The difference in microbial diversity between patients was much greater than the variability within patients by proximal vs. distal site or by forceps type. Limitations T-RFLP is based on PCR amplification, so it is not always sensitive to rare bacterial species. Conclusion Standard unsheathed forceps appear to be sufficient for microbiota sample collection from the terminal ileum. PMID:21317176

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

PubMed

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

2016-05-01

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

The extent of physician participation in Medicaid: a comparison of physician estimates and aggregated patient records.

PubMed Central

Kletke, P R; Davidson, S M; Perloff, J D; Schiff, D W; Connelly, J P

1985-01-01

This article compares two measures of the extent of physician participation in Medicaid programs. The first, which has been used in most research to date on the subject, is based on physician estimates of the proportion of their patients who are Medicaid patients. The second derives from encounter forms for a sample of visits to the interviewed physicians. The comparison shows that physicians in the sample tended to overestimate by 40 percent the extent of their Medicaid participation. Because the two measures are highly correlated, the analysis of the determinants of Medicaid participation was not affected by the measure used. However, since physicians tended to overstate the proportion of Medicaid patients in their practices, interview data should not be used to measure the amount of physician participation or to calculate elasticities for the effects of policy changes on the extent of participation. PMID:3910615

Clinical Validation of Therapeutic Drug Monitoring of Imipenem in Spent Effluent in Critically Ill Patients Receiving Continuous Renal Replacement Therapy: A Pilot Study

PubMed Central

Wen, Aiping; Li, Zhe; Yu, Junxian; Li, Ren; Cheng, Sheng; Duan, Meili; Bai, Jing

2016-01-01

Objectives The primary objective of this pilot study was to investigate whether the therapeutic drug monitoring of imipenem could be performed with spent effluent instead of blood sampling collected from critically ill patients under continuous renal replacement therapy. Methods A prospective open-label study was conducted in a real clinical setting. Both blood and effluent samples were collected pairwise before imipenem administration and 0.5, 1, 1.5, 2, 3, 4, 6, and 8 h after imipenem administration. Plasma and effluent imipenem concentrations were determined by reversed-phase high-performance liquid chromatography with ultraviolet detection. Pharmacokinetic and pharmacodynamic parameters of blood and effluent samples were calculated. Results Eighty-three paired plasma and effluent samples were obtained from 10 patients. The Pearson correlation coefficient of the imipenem concentrations in plasma and effluent was 0.950 (P<0.0001). The average plasma-to-effluent imipenem concentration ratio was 1.044 (95% confidence interval, 0.975 to 1.114) with Bland-Altman analysis. No statistically significant difference was found in the pharmacokinetic and pharmacodynamic parameters tested in paired plasma and effluent samples with Wilcoxon test. Conclusion Spent effluent of continuous renal replacement therapy could be used for therapeutic drug monitoring of imipenem instead of blood sampling in critically ill patients. PMID:27093294

Detection of Mycobacterium tuberculosis in extrapulmonary biopsy samples using PCR targeting IS6110, rpoB, and nested-rpoB PCR Cloning

PubMed Central

Meghdadi, Hossein; Khosravi, Azar D.; Ghadiri, Ata A.; Sina, Amir H.; Alami, Ameneh

2015-01-01

Present study was aimed to examine the diagnostic utility of polymerase chain reaction (PCR) and nested PCR techniques for the detection of Mycobacterium tuberculosis (MTB) DNA in samples from patients with extra pulmonary tuberculosis (EPTB). In total 80 formalin-fixed, paraffin-embedded (FFPE) samples comprising 70 samples with definite diagnosis of EPTB and 10 samples from known non- EPTB on the basis of histopathology examination, were included in the study. PCR amplification targeting IS6110, rpoB gene and nested PCR targeting the rpoB gene were performed on the extracted DNAs from 80 FFPE samples. The strong positive samples were directly sequenced. For negative samples and those with weak band in nested-rpoB PCR, TA cloning was performed by cloning the products into the plasmid vector with subsequent sequencing. The 95% confidence intervals (CI) for the estimates of sensitivity and specificity were calculated for each method. Fourteen (20%), 34 (48.6%), and 60 (85.7%) of the 70 positive samples confirmed by histopathology, were positive by rpoB-PCR, IS6110-PCR, and nested-rpoB PCR, respectively. By performing TA cloning on samples that yielded weak (n = 8) or negative results (n = 10) in the PCR methods, we were able to improve their quality for later sequencing. All samples with weak band and 7 out of 10 negative samples, showed strong positive results after cloning. So nested-rpoB PCR cloning revealed positivity in 67 out of 70 confirmed samples (95.7%). The sensitivity of these combination methods was calculated as 95.7% in comparison with histopathology examination. The CI for sensitivity of the PCR methods were calculated as 11.39–31.27% for rpoB-PCR, 36.44–60.83% for IS6110- PCR, 75.29–92.93% for nested-rpoB PCR, and 87.98–99.11% for nested-rpoB PCR cloning. The 10 true EPTB negative samples by histopathology, were negative by all tested methods including cloning and were used to calculate the specificity of the applied methods. The CI for 100% specificity of each PCR method were calculated as 69.15–100%. Our results indicated that nested-rpoB PCR combined with TA cloning and sequencing is a preferred method for the detection of MTB DNA in EPTB samples with high sensitivity and specificity which confirm the histopathology results. PMID:26191059

Detection of Mycobacterium tuberculosis in extrapulmonary biopsy samples using PCR targeting IS6110, rpoB, and nested-rpoB PCR Cloning.

PubMed

Meghdadi, Hossein; Khosravi, Azar D; Ghadiri, Ata A; Sina, Amir H; Alami, Ameneh

2015-01-01

Present study was aimed to examine the diagnostic utility of polymerase chain reaction (PCR) and nested PCR techniques for the detection of Mycobacterium tuberculosis (MTB) DNA in samples from patients with extra pulmonary tuberculosis (EPTB). In total 80 formalin-fixed, paraffin-embedded (FFPE) samples comprising 70 samples with definite diagnosis of EPTB and 10 samples from known non- EPTB on the basis of histopathology examination, were included in the study. PCR amplification targeting IS6110, rpoB gene and nested PCR targeting the rpoB gene were performed on the extracted DNAs from 80 FFPE samples. The strong positive samples were directly sequenced. For negative samples and those with weak band in nested-rpoB PCR, TA cloning was performed by cloning the products into the plasmid vector with subsequent sequencing. The 95% confidence intervals (CI) for the estimates of sensitivity and specificity were calculated for each method. Fourteen (20%), 34 (48.6%), and 60 (85.7%) of the 70 positive samples confirmed by histopathology, were positive by rpoB-PCR, IS6110-PCR, and nested-rpoB PCR, respectively. By performing TA cloning on samples that yielded weak (n = 8) or negative results (n = 10) in the PCR methods, we were able to improve their quality for later sequencing. All samples with weak band and 7 out of 10 negative samples, showed strong positive results after cloning. So nested-rpoB PCR cloning revealed positivity in 67 out of 70 confirmed samples (95.7%). The sensitivity of these combination methods was calculated as 95.7% in comparison with histopathology examination. The CI for sensitivity of the PCR methods were calculated as 11.39-31.27% for rpoB-PCR, 36.44-60.83% for IS6110- PCR, 75.29-92.93% for nested-rpoB PCR, and 87.98-99.11% for nested-rpoB PCR cloning. The 10 true EPTB negative samples by histopathology, were negative by all tested methods including cloning and were used to calculate the specificity of the applied methods. The CI for 100% specificity of each PCR method were calculated as 69.15-100%. Our results indicated that nested-rpoB PCR combined with TA cloning and sequencing is a preferred method for the detection of MTB DNA in EPTB samples with high sensitivity and specificity which confirm the histopathology results.

CURB-65 Performance Among Admitted and Discharged Emergency Department Patients With Community-acquired Pneumonia.

PubMed

Sharp, Adam L; Jones, Jason P; Wu, Ivan; Huynh, Dan; Kocher, Keith E; Shah, Nirav R; Gould, Michael K

2016-04-01

Pneumonia severity tools were primarily developed in cohorts of hospitalized patients, limiting their applicability to the emergency department (ED). We describe current community ED admission practices and examine the accuracy of the CURB-65 to predict 30-day mortality for patients, either discharged or admitted with community-acquired pneumonia (CAP). A retrospective, observational study of adult CAP encounters in 14 community EDs within an integrated healthcare system. We calculated CURB-65 scores for all encounters and described the use of hospitalization, stratified by each score (0-5). We then used each score as a cutoff to calculate sensitivity, specificity, positive predictive value, negative predictive value (NPV), positive likelihood ratios, and negative likelihood ratios for predicting 30-day mortality. The sample included 21,183 ED encounters for CAP (7,952 discharged and 13,231 admitted). The C-statistic describing the accuracy of CURB-65 for predicting 30-day mortality in the full sample was 0.761 (95% confidence interval [CI], 0.747-0.774). The C-statistic was 0.864 (95% CI, 0.821-0.906) among patients discharged from the ED compared with 0.689 (95% CI, 0.672-0.705) among patients who were admitted. Among all ED encounters a CURB-65 threshold of ≥1 was 92.8% sensitive and 38.0% specific for predicting mortality, with a 99.9% NPV. Among all encounters, 62.5% were admitted, including 36.2% of those at lowest risk (CURB-65 = 0). CURB-65 had very good accuracy for predicting 30-day mortality among patients discharged from the ED. This severity tool may help ED providers risk stratify patients to assist with disposition decisions and identify unwarranted variation in patient care. © 2016 by the Society for Academic Emergency Medicine.

Mathematical calculation skills required for drug administration in undergraduate nursing students to ensure patient safety: A descriptive study: Drug calculation skills in nursing students.

PubMed

Bagnasco, Annamaria; Galaverna, Lucia; Aleo, Giuseppe; Grugnetti, Anna Maria; Rosa, Francesca; Sasso, Loredana

2016-01-01

In the literature we found many studies that confirmed our concerns about nursing students' poor maths skills that directly impact on their ability to correctly calculate drug dosages with very serious consequences for patient safety. The aim of our study was to explore where students had most difficulty and identify appropriate educational interventions to bridge their mathematical knowledge gaps. This was a quali-quantitative descriptive study that included a sample of 726 undergraduate nursing students. We identified exactly where students had most difficulty and identified appropriate educational interventions to bridge their mathematical knowledge gaps. We found that the undergraduate nursing students mainly had difficulty with basic maths principles. Specific learning interventions are needed to improve their basic maths skills and their dosage calculation skills. For this purpose, we identified safeMedicate and eDose (Authentic World Ltd.), only that they are only available in English. In the near future we hope to set up a partnership to work together on the Italian version of these tools. Copyright © 2015 Elsevier Ltd. All rights reserved.

Evaluation of Sampling Recommendations From the Influenza Virologic Surveillance Right Size Roadmap for Idaho

PubMed Central

2017-01-01

Background The Right Size Roadmap was developed by the Association of Public Health Laboratories and the Centers for Disease Control and Prevention to improve influenza virologic surveillance efficiency. Guidelines were provided to state health departments regarding representativeness and statistical estimates of specimen numbers needed for seasonal influenza situational awareness, rare or novel influenza virus detection, and rare or novel influenza virus investigation. Objective The aim of this study was to compare Roadmap sampling recommendations with Idaho’s influenza virologic surveillance to determine implementation feasibility. Methods We calculated the proportion of medically attended influenza-like illness (MA-ILI) from Idaho’s influenza-like illness surveillance among outpatients during October 2008 to May 2014, applied data to Roadmap-provided sample size calculators, and compared calculations with actual numbers of specimens tested for influenza by the Idaho Bureau of Laboratories (IBL). We assessed representativeness among patients’ tested specimens to census estimates by age, sex, and health district residence. Results Among outpatients surveilled, Idaho’s mean annual proportion of MA-ILI was 2.30% (20,834/905,818) during a 5-year period. Thus, according to Roadmap recommendations, Idaho needs to collect 128 specimens from MA-ILI patients/week for situational awareness, 1496 influenza-positive specimens/week for detection of a rare or novel influenza virus at 0.2% prevalence, and after detection, 478 specimens/week to confirm true prevalence is ≤2% of influenza-positive samples. The mean number of respiratory specimens Idaho tested for influenza/week, excluding the 2009-2010 influenza season, ranged from 6 to 24. Various influenza virus types and subtypes were collected and specimen submission sources were representative in terms of geographic distribution, patient age range and sex, and disease severity. Conclusions Insufficient numbers of respiratory specimens are submitted to IBL for influenza laboratory testing. Increased specimen submission would facilitate meeting Roadmap sample size recommendations. PMID:28838883

Prediction of Normal Organ Absorbed Doses for [177Lu]Lu-PSMA-617 Using [44Sc]Sc-PSMA-617 Pharmacokinetics in Patients With Metastatic Castration Resistant Prostate Carcinoma.

PubMed

Khawar, Ambreen; Eppard, Elisabeth; Sinnes, Jean Phlippe; Roesch, Frank; Ahmadzadehfar, Hojjat; Kürpig, Stefan; Meisenheimer, Michael; Gaertner, Florian C; Essler, Markus; Bundschuh, Ralph A

2018-04-23

In vivo pharmacokinetic analysis of [Sc]Sc-PSMA-617 was used to determine the normal organ-absorbed doses that may result from therapeutic activity of [Lu]Lu-PSMA-617 and to predict the maximum permissible activity of [Lu]Lu-PSMA-617 for patients with metastatic castration-resistant prostate carcinoma. Pharmacokinetics of [Sc]Sc-PSMA-617 was evaluated in 5 patients with metastatic castration-resistant prostate carcinoma using dynamic PET/CT, followed by 3 static PET/CT acquisitions and blood sample collection over 19.5 hours, as well as urine sample collection at 2 time points. Total activity measured in source organs by PET imaging, as well as counts per milliliter measured in blood and urine samples, was decay corrected back to the time of injection using the half-life of Sc. Afterward, forward decay correction using the half-life of Lu was performed, extrapolating the pharmacokinetics of [Sc]Sc-PSMA-617 to that of [Lu]Lu-PSMA-617. Source organs residence times and organ-absorbed doses for [Lu]Lu-PSMA-617 were calculated using OLINDA/EXM software. Bone marrow self-dose was determined with indirect blood-based method, and urinary bladder contents residence time was estimated by trapezoidal approximation. The maximum permissible activity of [Lu]Lu-PSMA-617 was calculated for each patient considering external beam radiotherapy toxicity limits for radiation absorbed doses to kidneys, bone marrow, salivary glands, and whole body. The predicted mean organ-absorbed doses were highest in the kidneys (0.44 mSv/MBq), followed by the salivary glands (0.23 mSv/MBq). The maximum permissible activity was highly variable among patients; limited by whole body-absorbed dose (1 patient), marrow-absorbed dose (1 patient), and kidney-absorbed dose (3 patients). [Sc]Sc-PSMA-617 PET/CT imaging is feasible and allows theoretical extrapolation of the pharmacokinetics of [Sc]Sc-PSMA-617 to that of [Lu]Lu-PSMA-617, with the intent of predicting normal organ-absorbed doses and maximum permissible activity in patients scheduled for therapy with [Lu]Lu-PSMA-617.

How large a training set is needed to develop a classifier for microarray data?

PubMed

Dobbin, Kevin K; Zhao, Yingdong; Simon, Richard M

2008-01-01

A common goal of gene expression microarray studies is the development of a classifier that can be used to divide patients into groups with different prognoses, or with different expected responses to a therapy. These types of classifiers are developed on a training set, which is the set of samples used to train a classifier. The question of how many samples are needed in the training set to produce a good classifier from high-dimensional microarray data is challenging. We present a model-based approach to determining the sample size required to adequately train a classifier. It is shown that sample size can be determined from three quantities: standardized fold change, class prevalence, and number of genes or features on the arrays. Numerous examples and important experimental design issues are discussed. The method is adapted to address ex post facto determination of whether the size of a training set used to develop a classifier was adequate. An interactive web site for performing the sample size calculations is provided. We showed that sample size calculations for classifier development from high-dimensional microarray data are feasible, discussed numerous important considerations, and presented examples.

Nutrition and eating behavior in patients with chronic pain receiving long-term opioid therapy.

PubMed

Meleger, Alec L; Froude, Cameron Kiely; Walker, Joseph

2014-01-01

To assess eating behavior and nutrient intake in a group of patients who were diagnosed with chronic pain and received long-term opioid analgesic therapy. A descriptive, exploratory study with a convenience sample. An outpatient pain rehabilitation center. Patients diagnosed with chronic pain who received long-term opioid analgesic therapy (N = 50). Body mass index, the Food Frequency Questionnaire developed by the Nutrition Assessment Shared Resource of Fred Hutchinson Cancer Research Center, and the Eating Behavior Inventory. Of 50 participants, 14 (28%) and 22 (44%) were found to be overweight and obese, respectively. Mean (±SD) daily caloric intake (kcal) was 2008.5 ± 926.0 among men and 1694.8 ± 672.4 among women. Daily mean (±SD) consumption of fruit and vegetable servings, calculated with the summation method, was found to be 1.8 ± 1.1 and 1.9 ± 1.5, respectively. Our patient sample showed the following mean (±SD) daily intake of the following substances: added sugars (g), 74.4 ± 43.0; fiber (g), 17.3 ± 7.5; cholesterol (mg), 266.5 ± 234; saturated fat (g), 25.8 ± 16.8; omega-3 fatty acids (g), 1.6 ± 0.99; trans-fatty acids (g), 2.7 ± 1.7; sodium (mg), 2868.5 ± 1388.1; caffeine (mg), 199.9 ± 160.8; alcohol (g), 1.6 ± 0.5; vitamin D (IU), 244 ± 208; and calcium (mg), 1111.7 ± 672.1. The mean (±SD) score as calculated by the Eating Behavior Inventory was 74.9 ± 9.1. Obesity, deficient nutrient intake, and poor eating behavior were highly prevalent in our sample of patients with chronic pain who underwent long-term opioid therapy. Larger prospective studies are necessary to assess the eating behavior of patients with chronic pain who are treated with or without opioid analgesics. Copyright © 2014 American Academy of Physical Medicine and Rehabilitation. Published by Elsevier Inc. All rights reserved.

Disruption of the microbiota across multiple body sites in critically ill children.

PubMed

Rogers, Matthew B; Firek, Brian; Shi, Min; Yeh, Andrew; Brower-Sinning, Rachel; Aveson, Victoria; Kohl, Brittany L; Fabio, Anthony; Carcillo, Joseph A; Morowitz, Michael J

2016-12-29

Despite intense interest in the links between the microbiome and human health, little has been written about dysbiosis among ICU patients. We characterized microbial diversity in samples from 37 children in a pediatric ICU (PICU). Standard measures of alpha and beta diversity were calculated, and results were compared with data from adult and pediatric reference datasets. Bacterial 16S rRNA gene sequences were analyzed from 71 total tongue swabs, 50 skin swabs, and 77 stool samples or rectal swabs. The mean age of the PICU patients was 2.9 years (range 1-9 years), and many were chronically ill children that had previously been hospitalized in the PICU. Relative to healthy adults and children, alpha diversity was decreased in PICU GI and tongue but not skin samples. Measures of beta diversity indicated differences in community membership at each body site between PICU, adult, and pediatric groups. Taxonomic alterations in the PICU included enrichment of gut pathogens such as Enterococcus and Staphylococcus at multiple body sites and depletion of commensals such as Faecalibacterium and Ruminococcus from GI samples. Alpha and beta diversity were unstable over time in patients followed longitudinally. We observed the frequent presence of "dominant" pathogens in PICU samples at relative abundance >50%. PICU samples were characterized by loss of site specificity, with individual taxa commonly present simultaneously at three sample sites on a single individual. Some pathogens identified by culture of tracheal aspirates were commonly observed in skin samples from the same patient. We conclude that the microbiota in critically ill children differs sharply from the microbiota of healthy children and adults. Acknowledgement of dysbiosis associated with critical illness could provide opportunities to modulate the microbiota with precision and thereby improve patient outcomes.

Predictive Modeling and Concentration of the Risk of Suicide: Implications for Preventive Interventions in the US Department of Veterans Affairs

PubMed Central

McCarthy, John F.; Katz, Ira R.; Thompson, Caitlin; Kemp, Janet; Hannemann, Claire M.; Nielson, Christopher; Schoenbaum, Michael

2015-01-01

Objectives. The Veterans Health Administration (VHA) evaluated the use of predictive modeling to identify patients at risk for suicide and to supplement ongoing care with risk-stratified interventions. Methods. Suicide data came from the National Death Index. Predictors were measures from VHA clinical records incorporating patient-months from October 1, 2008, to September 30, 2011, for all suicide decedents and 1% of living patients, divided randomly into development and validation samples. We used data on all patients alive on September 30, 2010, to evaluate predictions of suicide risk over 1 year. Results. Modeling demonstrated that suicide rates were 82 and 60 times greater than the rate in the overall sample in the highest 0.01% stratum for calculated risk for the development and validation samples, respectively; 39 and 30 times greater in the highest 0.10%; 14 and 12 times greater in the highest 1.00%; and 6.3 and 5.7 times greater in the highest 5.00%. Conclusions. Predictive modeling can identify high-risk patients who were not identified on clinical grounds. VHA is developing modeling to enhance clinical care and to guide the delivery of preventive interventions. PMID:26066914

Predictive Modeling and Concentration of the Risk of Suicide: Implications for Preventive Interventions in the US Department of Veterans Affairs.

PubMed

McCarthy, John F; Bossarte, Robert M; Katz, Ira R; Thompson, Caitlin; Kemp, Janet; Hannemann, Claire M; Nielson, Christopher; Schoenbaum, Michael

2015-09-01

The Veterans Health Administration (VHA) evaluated the use of predictive modeling to identify patients at risk for suicide and to supplement ongoing care with risk-stratified interventions. Suicide data came from the National Death Index. Predictors were measures from VHA clinical records incorporating patient-months from October 1, 2008, to September 30, 2011, for all suicide decedents and 1% of living patients, divided randomly into development and validation samples. We used data on all patients alive on September 30, 2010, to evaluate predictions of suicide risk over 1 year. Modeling demonstrated that suicide rates were 82 and 60 times greater than the rate in the overall sample in the highest 0.01% stratum for calculated risk for the development and validation samples, respectively; 39 and 30 times greater in the highest 0.10%; 14 and 12 times greater in the highest 1.00%; and 6.3 and 5.7 times greater in the highest 5.00%. Predictive modeling can identify high-risk patients who were not identified on clinical grounds. VHA is developing modeling to enhance clinical care and to guide the delivery of preventive interventions.

Effects of sparse sampling in combination with iterative reconstruction on quantitative bone microstructure assessment

NASA Astrophysics Data System (ADS)

Mei, Kai; Kopp, Felix K.; Fehringer, Andreas; Pfeiffer, Franz; Rummeny, Ernst J.; Kirschke, Jan S.; Noël, Peter B.; Baum, Thomas

2017-03-01

The trabecular bone microstructure is a key to the early diagnosis and advanced therapy monitoring of osteoporosis. Regularly measuring bone microstructure with conventional multi-detector computer tomography (MDCT) would expose patients with a relatively high radiation dose. One possible solution to reduce exposure to patients is sampling fewer projection angles. This approach can be supported by advanced reconstruction algorithms, with their ability to achieve better image quality under reduced projection angles or high levels of noise. In this work, we investigated the performance of iterative reconstruction from sparse sampled projection data on trabecular bone microstructure in in-vivo MDCT scans of human spines. The computed MDCT images were evaluated by calculating bone microstructure parameters. We demonstrated that bone microstructure parameters were still computationally distinguishable when half or less of the radiation dose was employed.

Screening high-risk patients and assisting in diagnosing anxiety in primary care: the Patient Health Questionnaire evaluated

PubMed Central

2013-01-01

Background Questionnaires may help in detecting and diagnosing anxiety disorders in primary care. However, since utility of these questionnaires in target populations is rarely studied, the Patient Health Questionnaire anxiety modules (PHQ) were evaluated for use as: a) a screener in high-risk patients, and/or b) a case finder for general practitioners (GPs) to assist in diagnosing anxiety disorders. Methods A cross-sectional analysis was performed in 43 primary care practices in the Netherlands. The added value of the PHQ was assessed in two samples: 1) 170 patients at risk of anxiety disorders (or developing them) according to their electronic medical records (high-risk sample); 2) 141 patients identified as a possible ‘anxiety case’ by a GP (GP-identified sample). All patients completed the PHQ and were interviewed using the Mini International Neuropsychiatric interview to classify DSM-IV anxiety disorders. Psychometric properties were calculated, and a logistic regression analysis was performed to assess the diagnostic value of the PHQ. Results Using only the screening questions of the PHQ, the area under the curve was 83% in the high-risk sample. In GP-identified patients the official algorithm showed the best characteristics with an area under the curve of 77%. Positive screening questions significantly increased the odds of an anxiety disorder diagnosis in high-risk patients (odds ratio = 23.4; 95% confidence interval 6.9 to 78.8) as did a positive algorithm in GP-identified patients (odds ratio = 13.9; 95% confidence interval 3.8 to 50.6). Conclusions The PHQ screening questions can be used to screen for anxiety disorders in high-risk primary care patients. In GP-identified patients, the benefit of the PHQ is less evident. PMID:23865984

UK population norms for the modified dental anxiety scale with percentile calculator: adult dental health survey 2009 results

PubMed Central

2013-01-01

Background A recent UK population survey of oral health included questions to assess dental anxiety to provide mean and prevalence estimates of this important psychological construct. Methods A two-stage cluster sample was used for the survey across England, Wales, and Northern Ireland. The survey took place between October-December 2009, and January-April 2010. All interviewers were trained on survey procedures. Within the 7,233 households sampled there were 13,509 adults who were asked to participate in the survey and 11,382 participated (84%). Results The scale was reliable and showed some evidence of unidimensionality. Estimated proportion of participants with high dental anxiety (cut-off score = 19) was 11.6%. Percentiles and confidence intervals were presented and can be estimated for individual patients across various age ranges and gender using an on-line tool. Conclusions The largest reported data set on the MDAS from a representative UK sample was presented. The scale’s psychometrics is supportive for the routine assessment of patient dental anxiety to compare against a number of major demographic groups categorised by age and sex. Practitioners within the UK have a resource to estimate the rarity of a particular patient’s level of dental anxiety, with confidence intervals, when using the on-line percentile calculator. PMID:23799962

Ionized calcium analyzer with a built-in pH correction.

PubMed

Fogh-Andersen, N

1981-07-01

We describe a new semi-automated apparatus for simultaneously measuring the concentration of free calcium ion and of hydrogen ion (pH) at 37 degrees C. The sample volume is 110 microL. In addition to the actual values for these concentrations in the sample, the apparatus calculates the concentration of free calcium ion at pH 7.40. Mean values for serum from 51 fasting bedridden patients without calcium metabolic disorders and 64 fasting hospital employees were 1.192 and 1.232 mmol/L, respectively, with SD of 0.042 and 0.040 mmol/L, respectively. The within-series analytical SD was 12 mumol/L and the day-to-day SD of the pH-corrected concentration of free calcium ion was 21 mumol/L, as calculated from measurements made on a serum pool after equilibration with a CO2--air mixture. The mean dependency on pH as determined in 120 consecutive patients' sera equalled the built-in pH correction. The accuracy was evaluated by comparison with other calcium ion-selective electrodes.

Interventions to Improve Medication Adherence in Hypertensive Patients: Systematic Review and Meta-analysis.

PubMed

Conn, Vicki S; Ruppar, Todd M; Chase, Jo-Ana D; Enriquez, Maithe; Cooper, Pamela S

2015-12-01

This systematic review applied meta-analytic procedures to synthesize medication adherence interventions that focus on adults with hypertension. Comprehensive searching located trials with medication adherence behavior outcomes. Study sample, design, intervention characteristics, and outcomes were coded. Random-effects models were used in calculating standardized mean difference effect sizes. Moderator analyses were conducted using meta-analytic analogues of ANOVA and regression to explore associations between effect sizes and sample, design, and intervention characteristics. Effect sizes were calculated for 112 eligible treatment-vs.-control group outcome comparisons of 34,272 subjects. The overall standardized mean difference effect size between treatment and control subjects was 0.300. Exploratory moderator analyses revealed interventions were most effective among female, older, and moderate- or high-income participants. The most promising intervention components were those linking adherence behavior with habits, giving adherence feedback to patients, self-monitoring of blood pressure, using pill boxes and other special packaging, and motivational interviewing. The most effective interventions employed multiple components and were delivered over many days. Future research should strive for minimizing risks of bias common in this literature, especially avoiding self-report adherence measures.

Hospital Readmission Risk: Isolating Hospital from Patient Effects

PubMed Central

Krumholz, Harlan M.; Wang, Kun; Lin, Zhenqiu; Dharmarajan, Kumar; Horwitz, Leora I.; Ross, Joseph S.; Drye, Elizabeth E.; Bernheim, Susannah M.; Normand, Sharon-Lise T.

2017-01-01

Background To isolate hospital effects on hospitals’ risk-standardized readmission rates, we examined readmission outcomes among patients with multiple admissions for a similar diagnosis at >1 hospital within a given year. Methods We divided the Centers for Medicare & Medicaid Services hospital-wide readmission measure cohort from July 2014–June 2015 into 2 random samples. We used the first sample to calculate each hospital’s risk-standardized readmission rate and classified hospitals into performance quartiles. In the second sample, we identified patients with 2 admissions for similar diagnoses at different hospitals that occurred more than a month and less than a year apart, and compared observed readmission rates for those admitted to hospitals in different performance quartiles. Results In the sample used to characterize hospital performance, the median risk-standardized readmission rate was 15.5% (IQR 15.3%–15.8%). The other sample included 37,508 patients with 2 admissions for similar diagnoses at 4,272 different hospitals. The observed readmission rate was consistently higher when patients were admitted to hospitals in the worse performing quartile, but the only statistically significant difference was observed when the same patients were admitted to hospitals in the best and worst performing quartiles, in which the absolute readmission rate difference was 1.95 percentage points (95% CI, 0.39%–3.50%). Conclusions When the same patients were admitted with similar diagnoses to hospitals in the best performing quartile compared with the worst performing quartile for hospital readmission performance, there is a significant difference in rates of readmission within 30 days. The findings suggest that hospital quality contributes in part to readmission rates independent of patient factors. PMID:28902587

[Determination of ethylene glycol in biological fluids--propylene glycol interferences].

PubMed

Gomółka, Ewa; Cudzich-Czop, Sylwia; Sulka, Adrianna

2013-01-01

Many laboratories in Poland do not use gas chromatography (GC) method for determination of ethylene glycol (EG) and methanol in blood of poisoned patients, they use non specific spectrophotometry methods. One of the interfering substances is propylene glycol (PG)--compound present in many medical and cosmetic products: drops, air freshens, disinfectants, electronic cigarettes and others. In Laboratory of Analytical Toxicology and Drug Monitoring in Krakow determination of EG is made by GC method. The method enables to distinguish and make resolution of (EG) and (PG) in biological samples. In the years 2011-2012 in several serum samples from diagnosed patients PG was present in concentration from several to higher than 100 mg/dL. The aim of the study was to estimate PG interferences of serum EG determination by spectrophotometry method. Serum samples containing PG and EG were used in the study. The samples were analyzed by two methods: GC and spectrophotometry. Results of serum samples spiked with PG with no EG analysed by spectrophotometry method were improper ("false positive"). The results were correlated to PG concentration in samples. Calculated cross-reactivity of PG in the method was 42%. Positive results of EG measured by spectrophotometry method must be confirmed by reference GC method. Spectrophotometry method shouldn't be used for diagnostics and monitoring of patients poisoned by EG.

PCR-based detection of Toxoplasma gondii DNA in blood and ocular samples for diagnosis of ocular toxoplasmosis.

PubMed

Bourdin, C; Busse, A; Kouamou, E; Touafek, F; Bodaghi, B; Le Hoang, P; Mazier, D; Paris, L; Fekkar, A

2014-11-01

PCR detection of Toxoplasma gondii in blood has been suggested as a possibly efficient method for the diagnosis of ocular toxoplasmosis (OT) and furthermore for genotyping the strain involved in the disease. To assess this hypothesis, we performed PCR with 121 peripheral blood samples from 104 patients showing clinical and/or biological evidence of ocular toxoplasmosis and from 284 (258 patients) controls. We tested 2 different extraction protocols, using either 200 μl (small volume) or 2 ml (large volume) of whole blood. Sensitivity was poor, i.e., 4.1% and 25% for the small- and large-volume extractions, respectively. In comparison, PCR with ocular samples yielded 35.9% sensitivity, while immunoblotting and calculation of the Goldmann-Witmer coefficient yielded 47.6% and 72.3% sensitivities, respectively. Performing these three methods together provided 89.4% sensitivity. Whatever the origin of the sample (ocular or blood), PCR provided higher sensitivity for immunocompromised patients than for their immunocompetent counterparts. Consequently, PCR detection of Toxoplasma gondii in blood samples cannot currently be considered a sufficient tool for the diagnosis of OT, and ocular sampling remains necessary for the biological diagnosis of OT. Copyright © 2014, American Society for Microbiology. All Rights Reserved.

The Number of Patients and Events Required to Limit the Risk of Overestimation of Intervention Effects in Meta-Analysis—A Simulation Study

PubMed Central

Thorlund, Kristian; Imberger, Georgina; Walsh, Michael; Chu, Rong; Gluud, Christian; Wetterslev, Jørn; Guyatt, Gordon; Devereaux, Philip J.; Thabane, Lehana

2011-01-01

Background Meta-analyses including a limited number of patients and events are prone to yield overestimated intervention effect estimates. While many assume bias is the cause of overestimation, theoretical considerations suggest that random error may be an equal or more frequent cause. The independent impact of random error on meta-analyzed intervention effects has not previously been explored. It has been suggested that surpassing the optimal information size (i.e., the required meta-analysis sample size) provides sufficient protection against overestimation due to random error, but this claim has not yet been validated. Methods We simulated a comprehensive array of meta-analysis scenarios where no intervention effect existed (i.e., relative risk reduction (RRR) = 0%) or where a small but possibly unimportant effect existed (RRR = 10%). We constructed different scenarios by varying the control group risk, the degree of heterogeneity, and the distribution of trial sample sizes. For each scenario, we calculated the probability of observing overestimates of RRR>20% and RRR>30% for each cumulative 500 patients and 50 events. We calculated the cumulative number of patients and events required to reduce the probability of overestimation of intervention effect to 10%, 5%, and 1%. We calculated the optimal information size for each of the simulated scenarios and explored whether meta-analyses that surpassed their optimal information size had sufficient protection against overestimation of intervention effects due to random error. Results The risk of overestimation of intervention effects was usually high when the number of patients and events was small and this risk decreased exponentially over time as the number of patients and events increased. The number of patients and events required to limit the risk of overestimation depended considerably on the underlying simulation settings. Surpassing the optimal information size generally provided sufficient protection against overestimation. Conclusions Random errors are a frequent cause of overestimation of intervention effects in meta-analyses. Surpassing the optimal information size will provide sufficient protection against overestimation. PMID:22028777

Performance of the RAD-57 pulse CO-oximeter compared with standard laboratory carboxyhemoglobin measurement.

PubMed

Touger, Michael; Birnbaum, Adrienne; Wang, Jessica; Chou, Katherine; Pearson, Darion; Bijur, Polly

2010-10-01

We assess agreement between carboxyhemoglobin levels measured by the Rad-57 signal extraction pulse CO-oximeter (RAD), a Food and Drug Administration-approved device for noninvasive bedside measurement, and standard laboratory arterial or venous measurement in a sample of emergency department (ED) patients with suspected carbon monoxide poisoning. The study was a cross-sectional cohort design using a convenience sample of adult and pediatric ED patients in a Level I trauma, burn, and hyperbaric oxygen referral center. Measurement of RAD carboxyhemoglobin was performed simultaneously with blood sampling for laboratory determination of carboxyhemoglobin level. The difference between the measures for each patient was calculated as laboratory carboxyhemoglobin minus carboxyhemoglobin from the carbon monoxide oximeter. The limits of agreement from a Bland-Altman analysis are calculated as the mean of the differences between methods ±1.96 SDs above and below the mean. Median laboratory percentage carboxyhemoglobin level was 2.3% (interquartile range 1 to 8.5; range 0% to 38%). The mean difference between laboratory carboxyhemoglobin values and RAD values was 1.4% carboxyhemoglobin (95% confidence interval [CI] 0.2% to 2.6%). The limits of agreement of differences of measurement made with the 2 devices were -11.6% and 14.4% carboxyhemoglobin. This range exceeded the value of ±5% carboxyhemoglobin defined a priori as clinically acceptable. RAD correctly identified 11 of 23 patients with laboratory values greater than 15% carboxyhemoglobin (sensitivity 48%; 95% CI 27% to 69%). There was one case of a laboratory carboxyhemoglobin level less than 15%, in which the RAD device gave a result greater than 15% (specificity of RAD 96/97=99%; 95% CI 94% to 100%). In the range of carboxyhemoglobin values measured in this sample, the level of agreement observed suggests RAD measurement may not be used interchangeably with standard laboratory measurement. Copyright © 2010 American College of Emergency Physicians. Published by Mosby, Inc. All rights reserved.

A comparison of EuroQol 5-Dimension health-related utilities using Italian, UK, and US preference weights in a patient sample.

PubMed

Mozzi, Adelaide; Meregaglia, Michela; Lazzaro, Carlo; Tornatore, Valentina; Belfiglio, Maurizio; Fattore, Giovanni

2016-01-01

Weights associated with the EuroQol 5-Dimension 3-Level (EQ-5D-3L) instrument represent preferences for health states elicited from general population's samples. Weights have not been calculated for every country; however, empirical research shows that cross-country differences exist. This empirical study aims at investigating the impact of recently developed Italian weights in comparison with UK and US scores on health-related utility calculation using a sample of patients with Crohn's disease. The study is based on a survey on health-related quality of life in patients (n=552) affected by active Crohn's disease conducted in Italy from 2012 to 2013. Utilities computed through the Italian algorithm (mean: 0.76; SD: 0.20; median: 0.81) are generally higher than US (mean: 0.69; SD: 0.22; median: 0.77) and UK (mean: 0.57; SD: 0.32; median: 0.69) utilities, except for extremely severe health states where US values outweigh the Italian ones. UK preference weights generate the highest number of negative results. All the three value distributions are left-skewed due to very low scores associated with the most serious health states (ie, three or four levels equal to 3). As expected, despite the tariff set considered, more severe disease (Harvey Bradshaw Index >16) reduces the mean conditional EQ-5D-3L index (P<0.0001). Kendall's rank correlation between EQ Visual Analog Scale score and EQ-5D-3L index is positive (P<0.0001), even though patients tend to value their health-related quality of life more when responding to EQ-5D-3L questions than on EQ Visual Analog Scale. Regardless of the tariff set considered, ordinary least-square results highlight that more severe disease (Harvey Bradshaw Index >16) reduces the mean conditional EQ-5D-3L index (P<0.0001). Results reveal remarkable differences among the three national tariff sets and especially when severe health states occur, suggesting the need for country-specific preference weights when evaluating utilities, which can be problematic since they have not been calculated for every country yet.

Prevalence of isolated non-albumin proteinuria in the US population tested for both, urine total protein and urine albumin: An unexpected discovery.

PubMed

Katayev, Alexander; Zebelman, Arthur M; Sharp, Thomas M; Samantha Flynn; Bernstein, Richard K

2017-04-01

Isolated non-albumin proteinuria (NAP) is a condition when urine total protein concentrations are elevated without elevation of urine albumin. The prevalence of NAP in the US population tested for both, urine total protein and albumin was assessed in this study. The database of a US nationwide laboratory network was queried for test results when random urine albumin was ordered together with urine total protein and also when timed 24-hour urine albumin was ordered together with urine total protein. The total prevalence of NAP in the US population tested for both, urine total protein and albumin was calculated for patient groups having normal and low-normal urine albumin (random and timed) with elevated and severely increased urine total protein (random and timed). Also, the prevalence of NAP was calculated for patients with normal urine albumin to assess the probability of missing proteinuria if only urine albumin is measured. The prevalence of NAP in the random samples group was 10.1% (15.2% for females and 4.7% for males). Among patients with normal random albumin, there were 20.0% (27.3% of females and 10.7% of males) patients with NAP. The prevalence of NAP in the timed samples group was 24.6% (29.8% for females and 18.5% for males). Among patients with normal timed urine albumin, there were 36.2% (40.0% of females and 30.8% of males) patients with NAP. There was a strong positive association with female gender and NAP in most patients groups. Testing for only urine (micro)albumin can miss up to 40% of females and 30.8% of males with gross proteinuria. Copyright © 2016 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

Diazepam and Meclizine Are Equally Effective in the Treatment of Vertigo: An Emergency Department Randomized Double-Blind Placebo-Controlled Trial.

PubMed

Shih, Richard D; Walsh, Brian; Eskin, Barnet; Allegra, John; Fiesseler, Frederick W; Salo, Dave; Silverman, Michael

2017-01-01

Vertigo is a debilitating disease that is commonly encountered in the emergency department (ED). Diazepam and meclizine are oral medications that are commonly used to alleviate symptoms. We sought to determine whether meclizine or diazepam is superior in the treatment of patients with peripheral vertigo in the ED. We performed a double-blind clinical trial at a suburban, teaching ED. We randomized a convenience sample of adult patients with acute peripheral vertigo (APV) to diazepam 5 mg or meclizine 25 mg orally. Demographic and historical features were recorded on a standardized data form. Patients recorded their initial level (t0) of vertigo on a 100-mm visual analog scale (VAS) and after 30 min (t30) and 60 min (t60). The primary outcome parameter was the mean change in VAS score from t0 to t60. Differences between groups and 95% confidence intervals were calculated. Our a priori power calculation estimated that a sample size of 20 patients in each group was required to have an 80% power to detect a difference of 20 mm between treatment groups. There were 20 patients in the diazepam group and 20 in the meclizine group. The two groups were similar with respect to patient demographics and presenting signs and symptoms. At t60, the mean improvements in the diazepam and meclizine groups were 36 and 40, respectively (difference -4; 95% confidence interval -20 to 12; p = 0.60). We found no difference between oral diazepam and oral meclizine for the treatment of ED patients with acute peripheral vertigo. Copyright © 2016 Elsevier Inc. All rights reserved.

Suicide Rates After Discharge From Psychiatric Facilities: A Systematic Review and Meta-analysis.

PubMed

Chung, Daniel Thomas; Ryan, Christopher James; Hadzi-Pavlovic, Dusan; Singh, Swaran Preet; Stanton, Clive; Large, Matthew Michael

2017-07-01

High rates of suicide after psychiatric hospitalization are reported in many studies, yet the magnitude of the increases and the factors underlying them remain unclear. To quantify the rates of suicide after discharge from psychiatric facilities and examine what moderates those rates. English-language, peer-reviewed publications published from January 1, 1946, to May 1, 2016, were located using MEDLINE, PsychINFO, and EMBASE with the search terms ((suicid*).ti AND (hospital or discharg* OR inpatient or in-patient OR admit*).ab and ((mortality OR outcome* OR death*) AND (psych* OR mental*)).ti AND (admit* OR admis* or hospital* OR inpatient* OR in-patient* OR discharg*).ab. Hand searching was also done. Studies reporting the number of suicides among patients discharged from psychiatric facilities and the number of exposed person-years and studies from which these data could be calculated. The meta-analysis adhered to Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) and Meta-analysis of Observational Studies in Epidemiology (MOOSE) guidelines. A random-effects model was used to calculate a pooled estimate of postdischarge suicides per 100 000 person-years. The suicide rate after discharge from psychiatric facilities was the main outcome, and the association between the duration of follow-up and the year of the sampling were the main a priori moderators. A total of 100 studies reported 183 patient samples (50 samples of females, 49 of males, and 84 of mixed sex; 129 of adults or unspecified patients, 20 of adolescents, 19 of older patients, and 15 from long-term or forensic discharge facilities), including a total of 17 857 suicides during 4 725 445 person-years. The pooled estimate postdischarge suicide rate was 484 suicides per 100 000 person-years (95% CI, 422-555 suicides per 100 000 person-years; prediction interval, 89-2641), with high between-sample heterogeneity (I2 = 98%). The suicide rate was highest within 3 months after discharge (1132; 95% CI, 874-1467) and among patients admitted with suicidal ideas or behaviors (2078; 95% CI, 1512-2856). Pooled suicide rates per 100 000 patients-years were 654 for studies with follow-up periods of 3 months to 1 year, 494 for studies with follow-up periods of 1 to 5 years, 366 for studies with follow-up periods of 5 to 10 years, and 277 for studies with follow-up periods longer than 10 years. Suicide rates were higher among samples collected in the periods 1995-2004 (656; 95% CI, 518-831) and 2005-2016 (672; 95% CI, 428-1055) than in earlier samples. The immediate postdischarge period is a time of marked risk, but rates of suicide remain high for many years after discharge. Patients admitted because of suicidal ideas or behaviors and those in the first months after discharge should be a particular focus of concern. Previously admitted patients should be able to access long-term care and assistance.

Assessment of haemodialysis adequacy by ionic dialysance: intra-patient variability of delivered treatment.

PubMed

McIntyre, Christopher W; Lambie, Stewart H; Taal, Maarten W; Fluck, Richard J

2003-03-01

Adequate delivered dose of solute removal (as assessed by urea reduction and calculation of Kt/V) is an important determinant of clinical outcome in chronic haemodialysis (HD) patients. The requirement for multiple blood sampling and efforts taken to minimize the effects of rebound on post-treatment samples ensure Kt/V is measured only intermittently. On-line conductivity monitoring (using sodium flux as a surrogate for urea) allows the repeated non-invasive measurement of Kt/V on each HD treatment. We have studied the accuracy of this method of measuring Kt/V, and the variability of treatment dose delivered to individual patients. We prospectively studied 26 established chronic HD patients over 4 weeks (316 treatments). Patients were dialysed using Hospal Integra dialysis monitors, equipped with Diascan modules to measure Kt/V. Data were downloaded automatically to a central computer server. Urea reduction was measured (once a week) by a two-pool calculation using 30 min post-treatment sampling. Treatment time, Q(B) and modality were fully delivered in all treatments analysed (97% of total). Kt/V measured by ionic dialysance (Kt/V(ID)) correlated highly with that derived from measurement of urea reduction (R(2)=0.92, P<0.0001). Kt/V(ID) underestimated urea-based Kt/V by a mean of only 1.5% (95% CI 0.18-2.9%). Kt/V(ID) varied greatly within individual patients with a mean CV of 0.13+/-0.10 (95% CI 0.05-0.3). If a Kt/V(ID) of 1.0 is considered 'adequate', 55% of the patients had variations that would have potentially altered their status as being adequately or inadequately dialysed, as the range of Kt/V readings cross that point during the study period. In conclusion, Kt/V(ID) seems to be an accurate and readily obtained measure of adequacy. Substantial variation in Kt/V implies repeated measures (ideally for all treatments) are necessary to gain a true picture of the mean treatment dose being delivered to patients.

Low sensitivity and frequent cross-reactions in commercially available antibody detection ELISA assays for Taenia solium cysticercosis.

PubMed

Garcia, Hector H; Castillo, Yesenia; Gonzales, Isidro; Bustos, Javier A; Saavedra, Herbert; Jacob, Louis; Del Brutto, Oscar H; Wilkins, Patricia P; Gonzalez, Armando E; Gilman, Robert H

2018-01-01

To evaluate the diagnostic performance of two commercially available ELISA kits, Novalisa ® and Ridascreen ® , for the detection of antibodies to Taenia solium, compared to serological diagnosis of neurocysticercosis (NCC) by LLGP-EITB (electro-immunotransfer blot assay using lentil-lectin purified glycoprotein antigens). Archive serum samples from patients with viable NCC (n = 45) or resolved, calcified NCC (n = 45), as well as sera from patients with other cestode parasites (hymenolepiasis, n = 45 and cystic hydatid disease, n = 45), were evaluated for cysticercosis antibody detection using two ELISA kits, Novalisa ® and Ridascreen ® . All NCC samples had previously tested positive, and all samples from heterologous infections were negative on LLGP-EITB for cysticercosis. Positive rates were calculated by kit and sample group and compared between the two kits. Compared to LLGP-EITB, the sensitivity of both ELISA assays to detect specific antibodies in patients with viable NCC was low (44.4% and 22.2%), and for calcified NCC, it was only 6.7% and 4.5%. Sera from patients with cystic hydatid disease were highly cross-reactive in both ELISA assays (38/45, 84.4%; and 25/45, 55.6%). Sera from patients with hymenolepiasis cross-reacted in five cases in one of the assays (11.1%) and in only one sample with the second assay (2.2%). The performance of Novalisa ® and Ridascreen ® was poor. Antibody ELISA detection cannot be recommended for the diagnosis of neurocysticercosis. © 2017 John Wiley & Sons Ltd.

Health related quality of life in patients with neuroendocrine tumors compared with the general Norwegian population.

PubMed

Haugland, Trude; Vatn, Morten H; Veenstra, Marijke; Wahl, Astrid Klopstad; Natvig, Gerd Karin

2009-08-01

Health related quality of life (HRQoL) was characterized among patients with neuroendocrine tumor (NET) and compared with the general Norwegian population. A cross sectional, comparative design was chosen, and the samples comprised 196 NET patients and 5,258 individuals from the general Norwegian population. We used Chi-square cross tab calculations to evaluate sociodemographic characteristics, T-tests for independent samples and Analysis of Variance (ANOVA) in order to compare HRQoL (SF-36) scores across a range of background variables. Furthermore, T-tests were used to analyze differences in HRQoL scores between the samples. NET patients demonstrated significantly lower on all HRQoL subscales when compared with the general population with the lowest values on general health, physical limitation and vitality. Individuals above 70 years reported lower scores on physical functioning and physical limitations compared with those who were younger. Individuals with higher levels of education reported increased physical functioning compared with those with less education and full-time or part-time workers described higher physical functioning and less physical limitations compared with those who were retired. All SF-36 HRQoL scores were significantly lower among the NET patients when compared with the general population. Assistance from health personnel to NET patients should focus on those domains.

SU-F-T-115: Uncertainty in the Esophagus Dose in Retrospective Epidemiological Study of Breast Cancer Radiotherapy Patients

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

Mosher, E; Kim, S; Lee, C

Purpose: Epidemiological studies of second cancer risks in breast cancer radiotherapy patients often use generic patient anatomy to reconstruct normal tissue doses when CT images of patients are not available. To evaluate the uncertainty involved in the dosimetry approach, we evaluated the esophagus dose in five sample patients by simulating breast cancer treatments. Methods: We obtained the diagnostic CT images of five anonymized adult female patients in different Body Mass Index (BMI) categories (16– 36kg/m2) from National Institutes of Health Clinical Center. We contoured the esophagus on the CT images and imported them into a Treatment Planning System (TPS) tomore » create treatment plans and calculate esophagus doses. Esophagus dose was calculated once again via experimentally-validated Monte Carlo (MC) transport code, XVMC under the same geometries. We compared the esophagus doses from TPS and the MC method. We also investigated the degree of variation in the esophagus dose across the five patients and also the relationship between the patient characteristics and the esophagus doses. Results: Eclipse TPS using Analytical Anisotropic Algorithm (AAA) significantly underestimates the esophagus dose in breast cancer radiotherapy compared to MC. In the worst case, the esophagus dose from AAA was only 40% of the MC dose. The Coefficient of Variation across the patients was 48%. We found that the maximum esophagus dose was up to 2.7 times greater than the minimum. We finally observed linear relationship (Dose = 0.0218 × BMI – 0.1, R2=0.54) between patient’s BMI and the esophagus doses. Conclusion: We quantified the degree of uncertainty in the esophagus dose in five sample breast radiotherapy patients. The results of the study underscore the importance of individualized dose reconstruction for the study cohort to avoid misclassification in the risk analysis of second cancer. We are currently extending the number of patients up to 30.« less

The RBANS Effort Index: Base rates in geriatric samples

PubMed Central

Duff, Kevin; Spering, Cynthia C.; O’Bryant, Sid E.; Beglinger, Leigh J.; Moser, David J.; Bayless, John D.; Culp, Kennith R.; Mold, James W.; Adams, Russell L.; Scott, James G.

2011-01-01

The Effort Index (EI) of the RBANS was developed to assist clinicians in discriminating patients who demonstrate good effort from those with poor effort. However, there are concerns that older adults might be unfairly penalized by this index, which uses uncorrected raw scores. Using five independent samples of geriatric patients with a broad range of cognitive functioning (e.g., cognitively intact, nursing home residents, probable Alzheimer’s disease), base rates of failure on the EI were calculated. In cognitively intact and mildly impaired samples, few older individuals were classified as demonstrating poor effort (e.g., 3% in cognitively intact). However, in the more severely impaired geriatric patients, over one third had EI scores that fell above suggested cut-off scores (e.g., 37% in nursing home residents, 33% in probable Alzheimer’s disease). In the cognitively intact sample, older and less educated patients were more likely to have scores suggestive of poor effort. Education effects were observed in 3 of the 4 clinical samples. Overall cognitive functioning was significantly correlated with EI scores, with poorer cognition being associated with greater suspicion of low effort. The current results suggest that age, education, and level of cognitive functioning should be taken into consideration when interpreting EI results and that significant caution is warranted when examining EI scores in elders suspected of having dementia. PMID:21390895

Flow cytometric quantification of intraperitoneal free tumor cells in patients with peritoneal metastasis.

PubMed

Kitayama, Joji; Emoto, Shigenobu; Yamaguchi, Hironori; Ishigami, Hironori; Kamei, Takao; Yamashita, Hiroharu; Seto, Yasuyuki; Matsuzaki, Keisuke; Watanabe, Toshiaki

2014-01-01

Peritoneal metastasis (PM) is the most life-threatening type of metastasis in abdominal malignancy. To improve the diagnostic accuracy of cytologic detection (CY) of free tumor cells (FTC) in the peritoneal cavity, we tried to quantify the FTC to leukocyte ratio using flow cytometry in patients with peritoneal metastasis. Cells were recovered from ascites or peritoneal lavages from 106 patients who underwent abdominal surgery and additional 89 samples which were obtained from peritoneal catheter or access port in patients with PM (+) gastric cancer. The cells were immunostained with monoclonal antibodies to CD45 and to CD326 (EpCAM). Using flow cytometry, CD326 (+) and CD45 (+) cells were classified as either tumor cells (T) or leukocytes (L) and the T/L ratio (TLR) was calculated. In 106 samples obtained by laparotomy, Median (M) of the TLR of PM (+) patients was 1.39% (0-807.87%) which was significantly higher than PM (-) patients (M=0%, 0-2.14%, P < 0.001). In PM (+) patients, 86 CY (+) samples showed higher TLR than 61 CY (-) samples (M=2.81%, 0.02-1868.44% vs. M=0%, 0-3.45%, p<0.0001). In all of the 24 patients who were monitored for TLR before and after intraperitoneal (IP) chemotherapy, the TLR was reduced which was more dramatic than the results of the change in cytology. TLR measured with FACS is an excellent reflection of the tumor spread in the peritoneal cavity and could be a reliable diagnostic biomarker to determine the severity of PM as well as effectiveness of IP chemotherapy. © 2013 International Clinical Cytometry Society.

Psychotropics and weak opioid analgesics in plasma samples of older hip fracture patients - detection frequencies and consistency with drug records.

PubMed

Waade, Ragnhild Birkeland; Molden, Espen; Martinsen, Mette Irene; Hermann, Monica; Ranhoff, Anette Hylen

2017-07-01

To determine use of psychotropic drugs and weak opioids in hip fracture patients by analysing plasma samples at admission, and compare detected drug frequencies with prescription registry data and drug records. Plasma from 250 hip fracture patients aged ≥65 years sampled at hospital admission were analysed by ultra-performance liquid chromatography-tandem mass spectrometry methods for detection of psychotropic drugs and weak opioid analgesics (alcohol also determined). Odds ratios for drugs detected in plasma of hip fracture patients vs. prescription frequencies of the same drugs in an age-, time- and region-matched reference population were calculated. Moreover, recorded and measured drugs were compared. Psychotropic drugs and/or weak opioid analgesics were detected in 158 (63%) of the patients (median age 84 years; 76% females), while alcohol was found in 19 patients (7.6%). The occurrence of diazepam (odds ratio 1.6; 95% confidence interval 1.1-2.4), nitrazepam (2.3; 1.3-4.1), selective serotonin reuptake inhibitors (1.9; 1.3-2.9) and mirtazapine (2.3; 1.2-4.3) was significantly higher in plasma samples of hip fracture patients than in prescription data from the reference population. Poor consistency between recorded and measured drugs was disclosed for z-hypnotics and benzodiazepines; e.g. diazepam was detected in 29 (11.6%), but only recorded in six (2.4%) of the patients. Plasma analysis shows that use of antidepressants and benzodiazepines in hip fracture patients is significantly more frequent than respective prescription frequencies in the general elderly population. Moreover, consistency between recorded and actual use of psychotropic fall-risk drugs is poor at hospital admission of hip fracture patients. © 2017 The British Pharmacological Society.

High variability in baseline urinary free cortisol values in patients with Cushing's disease.

PubMed

Petersenn, S; Newell-Price, J; Findling, J W; Gu, F; Maldonado, M; Sen, K; Salgado, L R; Colao, A; Biller, B M K

2014-02-01

Twenty-four-hour urinary free cortisol (UFC) sampling is commonly used to evaluate Cushing's syndrome. Because there are few data on UFC variability in patients with active Cushing's disease, we analysed baseline UFC in a large patient cohort with moderate-to-severe Cushing's disease and assessed whether variability correlates with hypercortisolism severity. These data will help clinicians establish the minimum number of UFC samples required to obtain reliable data. Observational study (enrolment phase of Phase III study). Patients (n = 152) with persistent/recurrent or de novo Cushing's disease and mean UFC (mUFC) ≥1·5×ULN (normal: 30-145 nmol/24 h) were included. Mean UFC level was calculated from four 24-h urine samples collected over 2 weeks. Over 600 24-h UFC samples were analysed. The mUFC levels of samples 1 and 2 and samples 3 and 4 were 1000 nmol/24 h (SD 1872) and 940 nmol/24 h (SD 2148), respectively; intrapatient coefficient of variation (CV) was 38% for mUFC. The intrapatient CV using all four samples was 52% (95% CI: 48-56). The intrapatient CV was 51% (95% CI: 44-58) for samples 1 and 2, 49% (95% CI: 43-56) for samples 3 and 4 and 54% (95% CI: 49-59) for samples 1, 2 and 3. Variability in mUFC increased as UFC levels increased. There were no correlations between UFC and clinical features of hypercortisolism. There is intrapatient variability of approximately 50% in 24-h UFC measurements, which is relevant to targets set to estimate any treatment effect. Analysing more than two 24-h collection periods in individual patients does not result in a relevant decrease in variability. Interestingly, UFC levels did not correlate with hypercortisolism severity. © 2013 The Authors. Clinical Endocrinology published by John Wiley & Sons Ltd.

Detailed faecal fat analysis using Fourier transform infrared spectroscopy: Exploring the possibilities.

PubMed

De Koninck, Anne-Sophie; Nys, Karen; Vandenheede, Brent; Van Biervliet, Stephanie; Speeckaert, Marijn M; Delanghe, Joris R

2016-11-01

Fourier transform infrared (FTIR) spectroscopic determination of faecal fat is a simple and elegant alternative for the classical Van De Kamer approach. Besides quantification of the total amount of fat, analysis of the lipase hydrolysis efficiency (fatty acid/triglyceride ratio), fatty acid chain length and trans-unsaturated fatty acids could provide a better monitoring of dietary treatment. Stool samples (26 routine samples and 36 cystic fibrosis patients) were analysed with the Perkin Elmer Spectrum Two® spectrometer (3500-450cm -1 ). Fatty acid/triglyceride ratio was calculated using the absorbance ratio at 2855:1746cm -1 . To estimate lipase hydrolysis efficiency, sample ratios were compared with the ratio of butter and pure free fatty acids. Mean fatty acid chain length was calculated using the absorbance ratio at 2855:1709cm -1 . The absorbance at 966cm -1 was used to trace the presence of trans-type unsaturated fatty acids. Butter showed a low fatty acid/triglyceride ratio (1.21) and pure free fatty acids a high fatty acid/triglyceride ratio (6.76). Mean fatty acid/triglyceride ratio of routine stool samples was 4.16±1.01. The applicability of fatty acid/triglyceride ratios was also tested in cystic fibrosis patients under treatment with a mean of 4.92±0.98. Relative absorbance contribution per carbon atom was 0.06 (ratio 1.06 for C18 standard, 0.91 for C16 standard). The mean ratio of the stool samples was 1.12 (mean acyl chain length of C19), with values ranging from 0.73 (C12) to 1.68 (C28). The presence of traceable amounts of trans-unsaturated fatty acids was also demonstrated. For the analysis of faecal material, FTIR provides unique information, difficult to obtain using other techniques. These findings offer perspectives for diet monitoring in patients with (non-)pancreatic malabsorption. Copyright © 2016 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

Can routine surveillance samples from tracheal aspirate predict bacterial flora in cases of ventilator-associated pneumonia?

PubMed

Lampati, L; Maggioni, E; Langer, M; Malacarne, P; Mozzo, R; Pesenti, A; Fumagalli, R

2009-10-01

The aim of this study was to investigate the hypothesis that periodical sampling of the tracheo-bronchial tree in the absence of clinical suspicion of pneumonia is useful to identify bacteria responsible for subsequent late ventilator associated pneumonia (VAP). This was a retrospective observational human study carried out in two medical-surgical intensive care units of two different hospitals. From January 1999 to December 2000, 559 patients, who received invasive respiratory support for more than 48 hours, were screened. Tracheal aspiration (TA) was performed once or twice weekly in all mechanically ventilated patients. The microbiological findings from TA surveillance cultures done in the eight days before suspicion of VAP were compared to those isolated from the positive diagnostic samples done for late onset VAP (after more than four days of mechanical ventilation). The sensitivity, specificity, and positive/negative predictive values of the ability of the surveillance sample to anticipate the VAP pathogen were calculated. Among the microorganisms isolated from TA, 68% were retrieved from diagnostic samples. All VAP pathogens previously isolated were from 43% of the TA samples. If TA was collected 2-4 days before the clinical diagnosis of VAP, pathogens were detected in 58% of samples. In contrast, only 27% were collected more than four days earlier (P<0.05). The positive predictive values for Pseudomonas aeruginosa and methicillin resistant Staphylococcus aureus from routine TA samples were 92% and 90%, respectively. The negative predictive values for Pseudomonas aeruginosa and methicillin resistant Staphylococcus aureus from routine TA samples were 75% and 89%, respectively. TA cultures in ventilated patients may help to predict pathogens. Early detection may lead to earlier treatment in long term ventilated patients when VAP is suspected.

Evaluating test-retest reliability in patient-reported outcome measures for older people: A systematic review.

PubMed

Park, Myung Sook; Kang, Kyung Ja; Jang, Sun Joo; Lee, Joo Yun; Chang, Sun Ju

2018-03-01

This study aimed to evaluate the components of test-retest reliability including time interval, sample size, and statistical methods used in patient-reported outcome measures in older people and to provide suggestions on the methodology for calculating test-retest reliability for patient-reported outcomes in older people. This was a systematic literature review. MEDLINE, Embase, CINAHL, and PsycINFO were searched from January 1, 2000 to August 10, 2017 by an information specialist. This systematic review was guided by both the Preferred Reporting Items for Systematic Reviews and Meta-Analyses checklist and the guideline for systematic review published by the National Evidence-based Healthcare Collaborating Agency in Korea. The methodological quality was assessed by the Consensus-based Standards for the selection of health Measurement Instruments checklist box B. Ninety-five out of 12,641 studies were selected for the analysis. The median time interval for test-retest reliability was 14days, and the ratio of sample size for test-retest reliability to the number of items in each measure ranged from 1:1 to 1:4. The most frequently used statistical methods for continuous scores was intraclass correlation coefficients (ICCs). Among the 63 studies that used ICCs, 21 studies presented models for ICC calculations and 30 studies reported 95% confidence intervals of the ICCs. Additional analyses using 17 studies that reported a strong ICC (>0.09) showed that the mean time interval was 12.88days and the mean ratio of the number of items to sample size was 1:5.37. When researchers plan to assess the test-retest reliability of patient-reported outcome measures for older people, they need to consider an adequate time interval of approximately 13days and the sample size of about 5 times the number of items. Particularly, statistical methods should not only be selected based on the types of scores of the patient-reported outcome measures, but should also be described clearly in the studies that report the results of test-retest reliability. Copyright © 2017 Elsevier Ltd. All rights reserved.

[Prevention of therapeutic inertia in the treatment of arterial hypertension by using a program of home blood pressure monitoring].

PubMed

Márquez Contreras, Emilio; Martín de Pablos, José Luis; Espinosa García, Jacinto; Casado Martínez, José Joaquín; Sanchez López, Eugenio; Escribano, José

2012-02-01

To evaluate the efficacy of a program of home blood pressure monitoring (HBPM) on therapeutic Inertia (TI) in mild-to-moderate hypertension (AHT). Controlled, randomised clinical trial. Forty six clinics in 35 primary care centres. Spain. A total of 232 patients with uncontrolled hypertension were included. Two groups with 116 patients were formed: 1) Control group (CG): standard health intervention; 2) Intervention group (IG): patients who were included in the HBPM program. TI was calculated by the ratio: Number of patients whose pharmacological treatment was not changed in each visit/Number of patients with an average BP 140mmHg and/or 90mmHg in the general population or 130 and/or 90 mmHg in diabetics. The mean BPs and the percentage of controlled patients were calculated. The mean number of people that required an intervention in order to avoid TI was calculated (NI). A total of 209 patients completed the study, with TI in 35.64% (95% CI=29.85%-41.43%) of the sample, and in 71.63% (95% CI=63.9-79.36%) of the uncontrolled hypertensive patients. The TI was 22.42% (95% CI=24.2-37%) in the IG and 50% (95% CI=37.75-62.25) in the CG (p<.05) in visit 2, and 25.23% (95% CI=14.84-35.62) and 46.07% (95% CI=33.85-58.29) in the final visit for IG and CG, respectively (P<.05). The NI was 4.3. TI was very significant among the uncontrolled hypertensive patients. The studied interventions are effective for improving TI. Copyright © 2010 Elsevier España, S.L. All rights reserved.

Angiographic core laboratory reproducibility analyses: implications for planning clinical trials using coronary angiography and left ventriculography end-points.

PubMed

Steigen, Terje K; Claudio, Cheryl; Abbott, David; Schulzer, Michael; Burton, Jeff; Tymchak, Wayne; Buller, Christopher E; John Mancini, G B

2008-06-01

To assess reproducibility of core laboratory performance and impact on sample size calculations. Little information exists about overall reproducibility of core laboratories in contradistinction to performance of individual technicians. Also, qualitative parameters are being adjudicated increasingly as either primary or secondary end-points. The comparative impact of using diverse indexes on sample sizes has not been previously reported. We compared initial and repeat assessments of five quantitative parameters [e.g., minimum lumen diameter (MLD), ejection fraction (EF), etc.] and six qualitative parameters [e.g., TIMI myocardial perfusion grade (TMPG) or thrombus grade (TTG), etc.], as performed by differing technicians and separated by a year or more. Sample sizes were calculated from these results. TMPG and TTG were also adjudicated by a second core laboratory. MLD and EF were the most reproducible, yielding the smallest sample size calculations, whereas percent diameter stenosis and centerline wall motion require substantially larger trials. Of the qualitative parameters, all except TIMI flow grade gave reproducibility characteristics yielding sample sizes of many 100's of patients. Reproducibility of TMPG and TTG was only moderately good both within and between core laboratories, underscoring an intrinsic difficulty in assessing these. Core laboratories can be shown to provide reproducibility performance that is comparable to performance commonly ascribed to individual technicians. The differences in reproducibility yield huge differences in sample size when comparing quantitative and qualitative parameters. TMPG and TTG are intrinsically difficult to assess and conclusions based on these parameters should arise only from very large trials.

Postimplant dosimetry using a Monte Carlo dose calculation engine: a new clinical standard.

PubMed

Carrier, Jean-François; D'Amours, Michel; Verhaegen, Frank; Reniers, Brigitte; Martin, André-Guy; Vigneault, Eric; Beaulieu, Luc

2007-07-15

To use the Monte Carlo (MC) method as a dose calculation engine for postimplant dosimetry. To compare the results with clinically approved data for a sample of 28 patients. Two effects not taken into account by the clinical calculation, interseed attenuation and tissue composition, are being specifically investigated. An automated MC program was developed. The dose distributions were calculated for the target volume and organs at risk (OAR) for 28 patients. Additional MC techniques were developed to focus specifically on the interseed attenuation and tissue effects. For the clinical target volume (CTV) D(90) parameter, the mean difference between the clinical technique and the complete MC method is 10.7 Gy, with cases reaching up to 17 Gy. For all cases, the clinical technique overestimates the deposited dose in the CTV. This overestimation is mainly from a combination of two effects: the interseed attenuation (average, 6.8 Gy) and tissue composition (average, 4.1 Gy). The deposited dose in the OARs is also overestimated in the clinical calculation. The clinical technique systematically overestimates the deposited dose in the prostate and in the OARs. To reduce this systematic inaccuracy, the MC method should be considered in establishing a new standard for clinical postimplant dosimetry and dose-outcome studies in a near future.

Anxiety and depression in burn patients.

PubMed

Alvi, Tabassum; Assad, Fatima; Aurangzeb; Malik, M A Nasir

2009-01-01

The psychological aspects of burn injury have been researched in different parts of world producing different outcomes. Therefore objective of this research is to determine the frequency of Anxiety and Depression in burn patients. To assess the socio-demographic distribution of patients developing Anxiety and Depression and to determine the effects of burn related factors on development of Anxiety and Depression. A Case series was conducted at the Department of Burn, Pakistan Ordinance Factory Hospital, Wah Cantt. for a duration of 12 months commencing from June 2007 and concluded in May 2008. The study population comprised of hospitalized patients with 1% to 50%, selected through non probable sampling technique who were assessed for Anxiety and Depression on fifteen day after burn injury. Testing protocol comprised of questionnaire having socio-demographic variables and burn related variables. Beck Depression Inventory and Beck Anxiety Inventory was applied to evaluate Anxiety and Depression in Burn patients. Descriptive statistics like mean with Standard Deviation was calculated for age. Frequencies along with percentages were calculated for socio-demographic variables. The frequencies and proportions were also calculated for presence and extent of severity of depression and anxiety in burn patients. Fifty patients were included in the study, thirty patients (60%) were male and 20 (40%) were females. The mean age of participants was 33.64 +/- 19 years. Majority of participants, 38 (76%) had sustained burn injury up to 25%. Flame was found to be most common agent of burn injuries affecting 19 (38%) patients. Depression was seen amongst 29 (58%) patients. Thirteen (26 %) patients had mild, 7 (14%) had moderate and 9 (18%) had severe Depressive symptoms. Anxiety was seen among 41 (82%) patients, thirteen (26%) patients had mild, 11 (22%) had moderate and 17 (34%) had severe Anxiety symptoms. Anxiety was present in 41 (82%) and Depression was present in 29 (58%) patients following burn injury. This study highlights the importance of the simultaneous evaluation and management of Anxiety and Depression in burn injured patients.

Molecular Pathology of Patient Tumors, Patient-Derived Xenografts, and Cancer Cell Lines.

PubMed

Guo, Sheng; Qian, Wubin; Cai, Jie; Zhang, Likun; Wery, Jean-Pierre; Li, Qi-Xiang

2016-08-15

The Cancer Genome Atlas (TCGA) project has generated abundant genomic data for human cancers of various histopathology types and enabled exploring cancer molecular pathology per big data approach. We developed a new algorithm based on most differentially expressed genes (DEG) per pairwise comparisons to calculate correlation coefficients to be used to quantify similarity within and between cancer types. We systematically compared TCGA cancers, demonstrating high correlation within types and low correlation between types, thus establishing molecular specificity of cancer types and an alternative diagnostic method largely equivalent to histopathology. Different coefficients for different cancers in study may reveal that the degree of the within-type homogeneity varies by cancer types. We also performed the same calculation using the TCGA-derived DEGs on patient-derived xenografts (PDX) of different histopathology types corresponding to the TCGA types, as well as on cancer cell lines. We, for the first time, demonstrated highly similar patterns for within- and between-type correlation between PDXs and patient samples in a systematic study, confirming the high relevance of PDXs as surrogate experimental models for human diseases. In contrast, cancer cell lines have drastically reduced expression similarity to both PDXs and patient samples. The studies also revealed high similarity between some types, for example, LUSC and HNSCC, but low similarity between certain subtypes, for example, LUAD and LUSC. Our newly developed algorithm seems to be a practical diagnostic method to classify and reclassify a disease, either human or xenograft, with better accuracy than traditional histopathology. Cancer Res; 76(16); 4619-26. ©2016 AACR. ©2016 American Association for Cancer Research.

Quantification of diabetes consultations by the main primary health care nurse groups in Auckland, New Zealand.

PubMed

Daly, Barbara; Arroll, Bruce; Sheridan, Nicolette; Kenealy, Timothy; Scragg, Robert

2016-09-01

Diabetes prevalence continues to increase, with most diabetes patients managed in primary care. This report quantifies the number of diabetes consultations undertaken by primary healthcare nurses in Auckland, New Zealand. Of 335 primary healthcare nurses randomly selected, 287 (86%) completed a telephone interview in 2006-2008. On a randomly sampled day (from the past seven) for each nurse, 42% of the nurses surveyed (n=120) consulted 308 diabetes patients. From the proportion of nurses sampled in the study, it is calculated that the number of diabetes patients consulted by primary healthcare nurses per week in Auckland between September 2006 and February 2008 was 4210, with 61% consulted by practice, 23% by specialist and 16% by district nurses. These findings show that practice nurses carry out the largest number of community diabetes consultations by nurses. Their major contribution needs to be incorporated into future planning of the community management of diabetes.

Use of observed within-person variation of cardiac troponin in emergency department patients for determination of biological variation and percentage and absolute reference change values.

PubMed

Simpson, Aaron J; Potter, Julia M; Koerbin, Gus; Oakman, Carmen; Cullen, Louise; Wilkes, Garry J; Scanlan, Samuel L; Parsonage, William; Hickman, Peter E

2014-06-01

Many patients presenting to the emergency department (ED) for assessment of possible acute coronary syndrome (ACS) have low cardiac troponin concentrations that change very little on repeat blood draw. It is unclear if a lack of change in cardiac troponin concentration can be used to identify acutely presenting patients at low risk of ACS. We used the hs-cTnI assay from Abbott Diagnostics, which can detect cTnI in the blood of nearly all people. We identified a population of ED patients being assessed for ACS with repeat cTnI measurement who ultimately were proven to have no acute cardiac disease at the time of presentation. We used data from the repeat sampling to calculate total within-person CV (CV(T)) and, knowing the assay analytical CV (CV(A)), we could calculate within-person biological variation (CV(i)), reference change values (RCVs), and absolute RCV delta cTnI concentrations. We had data sets on 283 patients. Men and women had similar CV(i) values of approximately 14%, which was similar at all concentrations <40 ng/L. The biological variation was not dependent on the time interval between sample collections (t = 1.5-17 h). The absolute delta critical reference change value was similar no matter what the initial cTnI concentration was. More than 90% of subjects had a critical reference change value <5 ng/L, and 97% had values of <10 ng/L. With this hs-cTnI assay, delta cTnI seems to be a useful tool for rapidly identifying ED patients at low risk for possible ACS. © 2014 The American Association for Clinical Chemistry.

[Evaluation of the quality control of anticoagulation in patients with atrial fibrillation in a Primary Health Care Area of Madrid].

PubMed

Habashneh Sánchez, S; Abad Díaz, I; Tinajero Valle, C P; Cortés Palmero, A; Lobón Agúndez, M C; Muñoz Fernández, C

2016-01-01

To calculate the time in therapeutic range (TTR), as well as the scores on the CHADS2 scale in anticoagulated patients with non-valvular atrial fibrillation, attending the Primary Care Health Centre of Aravaca. Basic health area of Aravaca (Madrid). Retrospective observational study. The Community of Madrid provides a list of patients with non-valvular atrial fibrillation and on anticoagulant therapy in the centre. Excluding those with less than 8 INRs, who began treatment after January 2011, interrupted by inter-current treatment or had cancer or coagulopathy. The study period is from 1 January 2012 to 1 January 2013. The TTR (fraction of INRs in range) was the primary endpoint. The score was also calculated on the CHADS2 scale. A value of 56.28% TTR (59.5-53.1) was obtained from a sample of 963 INRs. Just over half (52%) of patients had a TTR<60%. There were 65 patients with a mean age of 80±7.5 years. The distribution of risk factors for the CHADS2 scale was: Heart failure 18.5%; hypertension 80%; diabetes 29.2%, and embolic events 18.5%. The results of our sample TTR is suboptimal (<60%), which implies an increased risk for embolic episodes and increased likelihood of bleeding. We need to incorporate into our clinical practice an objective measure of the quality of anticoagulation in order to identify poorly controlled patients and introduce corrective measures. Copyright © 2014 Sociedad Española de Médicos de Atención Primaria (SEMERGEN). Publicado por Elsevier España, S.L.U. All rights reserved.

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

PubMed

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

2017-09-01

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

Implication of Gastric Cancer Molecular Genetic Markers in Surgical Practice.

PubMed

Nemtsova, Marina V; Strelnikov, Vladimir V; Tanas, Alexander S; Bykov, Igor I; Zaletaev, Dmitry V; Rudenko, Viktoria V; Glukhov, Alexander I; Kchorobrich, Tatiana V; Li, Yi; Tarasov, Vadim V; Barreto, George E; Aliev, Gjumrakch

2017-10-01

We have investigated aberrant methylation of genes CDH1, RASSF1A, MLH1, N33, DAPK, expression of genes hTERT, MMP7, MMP9, BIRC5 (survivin), PTGS2, and activity of telomerase of 106 gastric tumor samples obtained intra-operatively and 53 gastric tumor samples from the same group of patients obtained endoscopically before surgery. Biopsy specimens obtained from 50 patients with chronic calculous cholecystitis were used as a control group. Together with tissue samples obtained from different sites remote to tumors, a total of 727 samples have been studied. The selected parameters comprise a system of molecular markers that can be used in both diagnostics of gastric cancer and in dynamic monitoring of patients after surgery. Special attention was paid to the use of molecular markers for the diagnostics of malignant process in the material obtained endoscopically since the efficacy of morphological diagnostics in biopsies is compromised by intratumoral heterogeneity, which may prevent reliable identification of tumor cells in the sampling. Our data indicated that certain molecular genetic events provided more sensitive yet specific markers of the tumor. We demonstrated that molecular profiles detected in preoperative biopsies were confirmed by the material obtained intra-operatively. The use of endoscopic material facilitates gastric tumors pre-operative diagnostics, improving early detection of gastric cancer and potential effective treatment strategies.

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

PubMed

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

2015-03-01

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

Comparative Study of GeneXpert with ZN Stain and Culture in Samples of Suspected Pulmonary Tuberculosis

PubMed Central

Bajaj, Ashish; Bhatia, Vinay; Dutt, Sarjana

2016-01-01

Introduction Tuberculosis remains one of the deadliest communicable diseases. There are number of tests available for the diagnosis of tuberculosis but conventional microscopy has low sensitivity and culture although gold standard, but takes longer time for positivity. On the other side, Nucleic acid amplification techniques due to its rapidity and sensitivity not only help in early diagnosis and management of tuberculosis especially in patients with high clinical suspicion like immunocompromised patients, history of contact with active tuberculosis patient etc., but also curtail the transmission of the disease. Aim To evaluate the sensitivity, specificity, positive predictive value and negative predictive value of Nucleic acid amplification assay (GeneXpert) using respiratory samples in patients with suspected pulmonary tuberculosis and compare with AFB smear microscopy (Ziehl Neelsen stain) and Acid Fast Bacilli (AFB) culture. Materials and Methods We retrospectively reviewed the respiratory samples of suspected pulmonary tuberculosis (including Bronchoalveolar lavage and sputum) of 170 patients from Jan 2015 to Nov 2015 for ZN stain, culture and GeneXpert (Xpert® MTB/Rif assay). The sensitivity, specificity, PPV and NPV of GeneXpert and ZN microscopy were calculated using Liquid culture of Mycobacterium tuberculosis as gold standard. Results A total of 170 patient samples were evaluated in final analysis. Of these, 14 samples were positive by all three methods used in our study. The overall sensitivity, specificity, PPV and NPV of GeneXpert were 86.8%, 93.1%, 78.5% and 96% respectively and for BAL sample, 81.4%, 93.4%, 73.3% and 95.7% respectively. The overall sensitivity and specificity of AFB smear microscopy were 22.2%, % and 78.5% respectively and for BAL sample 22.2% and 100% respectively. For AFB negative samples sensitivity and specificity were 79.1% and 93.1% respectively. Conclusion GeneXpert has a higher sensitivity than AFB smear microscopy in respiratory samples. GeneXpert can be a useful tool for early diagnosis of patients with high clinical suspicion of pulmonary tuberculosis. Positive GeneXpert, but culture negative results should be read cautiously and be well correlated with clinical and treatment history of the patient. The other major advantage of Gene Xpert is that it simultaneously detects Rifampicin resistance and especially beneficial in patient with MDR and HIV associated tuberculosis and should be studied further. PMID:27437212

Measurements of pulmonary gas exchange efficiency using expired gas and oximetry: results in normal subjects.

PubMed

West, John B; Wang, Daniel L; Prisk, G Kim

2018-04-01

We are developing a novel, noninvasive method for measuring the efficiency of pulmonary gas exchange in patients with lung disease. The patient wears an oximeter, and we measure the partial pressures of oxygen and carbon dioxide in inspired and expired gas using miniature analyzers. The arterial Po 2 is then calculated from the oximeter reading and the oxygen dissociation curve, using the end-tidal Pco 2 to allow for the Bohr effect. This calculation is only accurate when the oxygen saturation is <94%, and therefore, these normal subjects breathed 12.5% oxygen. When the procedure is used in patients with hypoxemia, they breathe air. The Po 2 difference between the end-tidal and arterial values is called the "oxygen deficit." Preliminary data show that this index increases substantially in patients with lung disease. Here we report measurements of the oxygen deficit in 20 young normal subjects (age 19 to 31 yr) and 11 older normal subjects (47 to 88 yr). The mean value of the oxygen deficit in the young subjects was 2.02 ± 3.56 mmHg (means ± SD). This mean is remarkably small. The corresponding value in the older group was 7.53 ± 5.16 mmHg (means ± SD). The results are consistent with the age-related trend of the traditional alveolar-arterial difference, which is calculated from the calculated ideal alveolar Po 2 minus the measured arterial Po 2 . That measurement requires an arterial blood sample. The present study suggests that this noninvasive procedure will be valuable in assessing the degree of impaired gas exchange in patients with lung disease.

A PCR method based on 18S rRNA gene for detection of malaria parasite in Balochistan.

PubMed

Shahwani, Zubeda; Aleem, Abdul; Ahmed, Nazeer; Mushtaq, Muhammad; Afridi, Sarwat

2016-12-01

To establish a polymerase chain reaction method based on 18S ribosomal ribonucleic acid gene for the detection of plasmodium deoxyribonucleic acid in patients suffering from malaria symptoms. This cross-sectional study was conducted from September 2013 to October 2014 in district Quetta of Pakistan's Balochistan province. Blood samples were collected from patients suffering from general symptoms of malaria. A polymerase chain reaction-based technique was applied for the diagnosis of malaria and detection of responsible species in the patients who were suspected to carry the parasite. Performance of this polymerase chain reaction method was compared against the microscopy results. Parasite number was also calculated for microscopy positive samples.All samples after the genomic deoxyribonucleic acid isolation were subjected to polymerase chain reaction amplification and agarose gel electrophoresis. Of the 200 samples, 114(57%) were confirmed as positive and 86(43%) as negative for malaria by microscopy. Polymerase chain reaction identified 124(62%) samples as positive and 76(38%) as negative for malaria. The comparative analysis of both diagnostic methods confirmed 109(54.5%) samples as positive by both techniques. Besides, 5(6.58%) samples were identified as false positive and 15(12.1%) samples as false negative by polymerase chain reaction. Sensitivity, specificity and positive predictive values for polymerase chain reaction in comparison to microscopy were 87.98%, 93.42% and 96%, respectively. Polymerase chain reaction-based methods in malaria diagnosis and species identification were found to be more effective than other techniques.

Improving the quality of biomarker discovery research: the right samples and enough of them.

PubMed

Pepe, Margaret S; Li, Christopher I; Feng, Ziding

2015-06-01

Biomarker discovery research has yielded few biomarkers that validate for clinical use. A contributing factor may be poor study designs. The goal in discovery research is to identify a subset of potentially useful markers from a large set of candidates assayed on case and control samples. We recommend the PRoBE design for selecting samples. We propose sample size calculations that require specifying: (i) a definition for biomarker performance; (ii) the proportion of useful markers the study should identify (Discovery Power); and (iii) the tolerable number of useless markers amongst those identified (False Leads Expected, FLE). We apply the methodology to a study of 9,000 candidate biomarkers for risk of colon cancer recurrence where a useful biomarker has positive predictive value ≥ 30%. We find that 40 patients with recurrence and 160 without recurrence suffice to filter out 98% of useless markers (2% FLE) while identifying 95% of useful biomarkers (95% Discovery Power). Alternative methods for sample size calculation required more assumptions. Biomarker discovery research should utilize quality biospecimen repositories and include sample sizes that enable markers meeting prespecified performance characteristics for well-defined clinical applications to be identified. The scientific rigor of discovery research should be improved. ©2015 American Association for Cancer Research.

Customising turnaround time indicators to requesting clinician: a 10-year study through balanced scorecard indicators.

PubMed

Salinas, Maria; López-Garrigós, Maite; Santo-Quiles, Ana; Gutierrez, Mercedes; Lugo, Javier; Lillo, Rosa; Leiva-Salinas, Carlos

2014-09-01

The purpose of this study is, first to present a 10-year monitoring of postanalytical turnaround time (TAT) adapted to different clinicians and patient situations, second to evaluate and analyse the indicators results during that period of time, and finally to show a synthetic appropriate indicator to be included in the balanced scorecard management system. TAT indicator for routine samples was devised as the percentage of certain key tests that were verified before a specific time on the phlebotomy day. A weighted mean synthetic indicator was also designed. They were calculated for inpatients at 15:00 and 12:00 and for primary care patients only at 15:00. The troponin TAT of emergency department patients, calculated as the difference between the troponin verification and registration time, was selected as the stat laboratory TAT indicator. The routine and stat TAT improved along the 10-year study period. The synthetic indicator showed the same trend. The implementation of systematic and continuous monitoring over years, promoted a continuous improvement in TAT which will probably benefit patient outcome and safety.

Reliability of criteria for borderline personality disorder: a comparison of DSM-III and the Diagnostic Interview for Borderline Patients.

PubMed

Frances, A; Clarkin, J F; Gilmore, M; Hurt, S W; Brown, R

1984-09-01

The authors compared the reliability of two methods of distinguishing borderline personality disorder--DSM-III and the Diagnostic Interview for Borderline Patients. The reference group, outpatients with other personality disorders and without major axis I pathology, was more difficult to distinguish from the patients with borderline personality disorder than such groups used in previous samples. The sensitivity and specificity of the Diagnostic Interview for Borderline Patients were calculated, with DSM-III used as a criterion. The findings confirm considerable overlap between borderline and schizotypal personality disorders, more impairment in functioning in borderline patients than in those with other personality disorders, and the high reliability with which borderline personality disorder can be diagnosed.

Distinctions between organic brain syndrome and functional psychiatric disorders: based on the geriatric mental state interview.

PubMed

Fleiss, J; Gurland, B; Roche, P D

1976-01-01

Discriminant function analysis was employed to study the ability of the Geriatric Mental Status interview to distinguish between patients diagnosed by the project as having an organic brain syndrome or a functional psychiatric disorder. In both New York and London, patients with organic brain syndrome scored significantly higher (p less than 0.05) than those with functional disorders on the factors of impaired memory, disorientation and incomprehensibility and significantly lower on the factors of depression and somatic concerns. Discriminant functions calculated from data on the New York and London patients separately significantly distinguished not only the patients on whom the functions were based but the patients in the other sample as well.

SU-F-T-148: Are the Approximations in Analytic Semi-Empirical Dose Calculation Algorithms for Intensity Modulated Proton Therapy for Complex Heterogeneities of Head and Neck Clinically Significant?

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

Yepes, P; UT MD Anderson Cancer Center, Houston, TX; Titt, U

2016-06-15

Purpose: Evaluate the differences in dose distributions between the proton analytic semi-empirical dose calculation algorithm used in the clinic and Monte Carlo calculations for a sample of 50 head-and-neck (H&N) patients and estimate the potential clinical significance of the differences. Methods: A cohort of 50 H&N patients, treated at the University of Texas Cancer Center with Intensity Modulated Proton Therapy (IMPT), were selected for evaluation of clinical significance of approximations in computed dose distributions. H&N site was selected because of the highly inhomogeneous nature of the anatomy. The Fast Dose Calculator (FDC), a fast track-repeating accelerated Monte Carlo algorithm formore » proton therapy, was utilized for the calculation of dose distributions delivered during treatment plans. Because of its short processing time, FDC allows for the processing of large cohorts of patients. FDC has been validated versus GEANT4, a full Monte Carlo system and measurements in water and for inhomogeneous phantoms. A gamma-index analysis, DVHs, EUDs, and TCP and NTCPs computed using published models were utilized to evaluate the differences between the Treatment Plan System (TPS) and FDC. Results: The Monte Carlo results systematically predict lower dose delivered in the target. The observed differences can be as large as 8 Gy, and should have a clinical impact. Gamma analysis also showed significant differences between both approaches, especially for the target volumes. Conclusion: Monte Carlo calculations with fast algorithms is practical and should be considered for the clinic, at least as a treatment plan verification tool.« less

Treatment of hyperthyroidism with radioiodine targeted activity: A comparison between two dosimetric methods.

PubMed

Amato, Ernesto; Campennì, Alfredo; Leotta, Salvatore; Ruggeri, Rosaria M; Baldari, Sergio

2016-06-01

Radioiodine therapy is an effective and safe treatment of hyperthyroidism due to Graves' disease, toxic adenoma, toxic multinodular goiter. We compared the outcomes of a traditional calculation method based on an analytical fit of the uptake curve and subsequent dose calculation with the MIRD approach, and an alternative computation approach based on a formulation implemented in a public-access website, searching for the best timing of radioiodine uptake measurements in pre-therapeutic dosimetry. We report about sixty-nine hyperthyroid patients that were treated after performing a pre-therapeutic dosimetry calculated by fitting a six-point uptake curve (3-168h). In order to evaluate the results of the radioiodine treatment, patients were followed up to sixty-four months after treatment (mean 47.4±16.9). Patient dosimetry was then retrospectively recalculated with the two above-mentioned methods. Several time schedules for uptake measurements were considered, with different timings and total number of points. Early time schedules, sampling uptake up to 48h, do not allow to set-up an accurate treatment plan, while schedules including the measurement at one week give significantly better results. The analytical fit procedure applied to the three-point time schedule 3(6)-24-168h gave results significantly more accurate than the website approach exploiting either the same schedule, or the single measurement at 168h. Consequently, the best strategy among the ones considered is to sample the uptake at 3(6)-24-168h, and carry out an analytical fit of the curve, while extra measurements at 48 and 72h lead only marginal improvements in the accuracy of therapeutic activity determination. Copyright © 2016 Associazione Italiana di Fisica Medica. Published by Elsevier Ltd. All rights reserved.

Classification of infections in intensive care units: a comparison of current definition of hospital-acquired infections and carrier state criterion.

PubMed

Zurek, Jiří; Fedora, Michal

2012-06-01

The rate of nosocomial infection appears to depend on whether it is calculated using the Center for Disease Control (CDC) or carrier state criteria. The objective of this study was to differentiate between primary endogenous (PE), secondary endogenous (SE) and exogenous (EX) infections, and to compare this classification with CDC criteria for nosocomial infections. Children hospitalized for more than 72 h at pediatric intensive care unit during 2004-2005 were enrolled. Children, who had the infection before the admission, and or did not develop an infection within the hospitalization were excluded. Surveillance samples were sampled on admission, and then twice a week. Diagnostic samples were obtained when infection was suspected based on the clinical condition and laboratory findings. Infections were evaluated as PE, SE and EX, and their incidences were compared with CDC criteria for nosocomial infections. One hundred seventy eight patients were enrolled in the study. Forty-four patients (24.7%) develop infection. Twenty-seven patients (61.3%) had PE, 10 patients (22.7%) had SE, and 7 patients (15.9%) had EX infection. Secondary endogenous and EX infections are considered as nosocomial, thus 17 patients (38.6%) had a nosocomial infection. Thirty-one patients (70.5%) met CDC criteria for nosocomial infections. Seventeen patients (55%) were classified as PE, and 14 patients (45%) as SE or EX infections. Seventy percent of infections (31 out of 44 patients) met the CDC criteria for nosocomial infections, but only 39% of infections (17 out of 44 patients) were classified as nosocomial based on carrier state classification.

Correlation Between Ki-67 Index, World Health Organization Grade and Patient Survival in Glial Tumors With Astrocytic Differentiation

PubMed Central

Dzhenkov, Deyan L; Kitanova, Martina; Donev, Ivan S; Ghenev, Peter

2017-01-01

Background Glioblastoma multiforme (GBM) is a class IV astrocytic tumor, the most malignant of the four groups of World Health Organization (WHO) tumors with astrocytic differentiation. Aim The aim of this study was to estab­lish whether a correlation exists between the Ki-67 index of tumors with astrocytic differentiation, WHO grade, and patient survival. Materials and methods A retrospective non-clinical approach to patient selection was chosen for the aim of the study. A total of 47 patients diagnosed and treated for CNS tumors with astrocytic differentiation in the St. Marina University Hospital, Varna, Bulgaria, from September 2012 to July 2016 were retrospectively included into the study cohort. The cases were tested for their immunohistochemistry (IHC) reaction with Ki-67 after their original Hematoxylin and Eosin and IHC slides were reviewed by a single author and blind coded. The Ki-67 positivity index of the nuclei was estimated after digitalization of the slides and calculated by the ImmunoRatio automated count­ing tool. The individual Ki-67 index and patient survival of each case were statistically compared. Results The histopathological groups, after the blind Ki-67 index automated calculation was carried out, revealed no WHO grade I, two WHO grade II samples, four WHO grade III samples and 41 WHO grade IV cases, and these were included in the analysis. The two samples of WHO grade II astrocytic tumors had a mean Ki-67 index of 25%; however, they comprised tumors with an individual index of 43% and 7%, both individual values with a highly unlikely index for this group. The four samples of WHO grade III had a mean Ki-67 index of 4%, standard deviation ±2.16 (p>0.05), with the lowest index being 1% and the highest one being 6%. Both WHO grade II and III did not include enough samples to allow for a proper statistical analysis of patient survival. The 41 GBM cases had a mean Ki-67 index of 17.34%, standard deviation ±10.79 (p>0.05). Statistical analysis of the Ki-67 index divid­ed dichotomously into two groups and patient survival revealed that cases with a high Ki-67 index had no significant difference in survival when compared to those with low expression. Conclusions Based on the reported results, the mean Ki-67 percentage of positive nuclei in GBM tumor sam­ples cannot be used to estimate the survival of patients. However, Ki-67 remains a valuable IHC pathological tool. PMID:28845375

Assessment of laboratory test utilization for HIV/AIDS care in urban ART clinics of Lilongwe, Malawi.

PubMed

Palchaudhuri, Sonali; Tweya, Hannock; Hosseinipour, Mina

2014-06-01

The 2011 Malawi HIV guidelines promote CD4 monitoring for pre-ART assessment and considering HIVRNA monitoring for ART response assessment, while some clinics used CD4 for both. We assessed clinical ordering practices as compared to guidelines, and determined whether the samples were successfully and promptly processed. We conducted a retrospective review of all patients seen in from August 2010 through July 2011,, in two urban HIV-care clinics that utilized 6-monthly CD4 monitoring regardless of ART status. We calculated the percentage of patients on whom clinicians ordered CD4 or HIVRNA analysis. For all samples sent, we determined rates of successful lab-processing, and mean time to returned results. Of 20581 patients seen, 8029 (39%) had at least one blood draw for CD4 count. Among pre-ART patients, 2668/2844 (93.8%) had CD4 counts performed for eligibility. Of all CD4 samples sent, 8082/9207 (89%) samples were successfully processed. Of those, mean time to processing was 1.6 days (s.d 1.5) but mean time to results being available to clinician was 9.3 days (s.d. 3.7). Regarding HIVRNA, 172 patients of 17737 on ART had a blood draw and only 118/213 (55%) samples were successfully processed. Mean processing time was 39.5 days (s.d. 21.7); mean time to results being available to clinician was 43.1 days (s.d. 25.1). During the one-year evaluated, there were multiple lapses in processing HIVRNA samples for up to 2 months. Clinicians underutilize CD4 and HIVRNA as monitoring tools in HIV care. Laboratory processing failures and turnaround times are unacceptably high for viral load analysis. Alternative strategies need to be considered in order to meet laboratory monitoring needs.

Evaluated the adverse effects of cadmium and aluminum via drinking water to kidney disease patients: Application of a novel solid phase microextraction method.

PubMed

Panhwar, Abdul Haleem; Kazi, Tasneem Gul; Naeemullah; Afridi, Hassan Imran; Shah, Faheem; Arain, Mohammad Balal; Arain, Salma Aslam

2016-04-01

In present study aluminum (Al) and cadmium (Cd) were determined in ground water samples and assesses human health risks associated with elevated concentrations of toxic metals in dissolved form, using a novel solid phase microextraction (SPμE). Ground water sample (n=200) and biological sample (blood) of patients having chronic kidney disorders (CKD) along with healthy control subjects of same area (southern part of Pakistan) were collected. A simple system, including the micropipette tip packed with modified ionic liquid-activated carbon cloth (IL-ACC) coated with 8-hydroxyqunilone (8-HQ) attached to syringe. The analytes in water and acid digested blood samples were manually drawn for 2-10 cycles (drawing/discharging) at different pH range. The analytes sorbed on coated ACC were then desorbed with 2.0molL(-1) HNO3 in ethanol by drawing/discharging cycles for 1-5 times. The concentration of extracted analytes was determined by electrothermal atomic absorption spectrometer. The influence of different variables on the extraction efficiency of Cd and Al, were optimized. The Al and Cd concentrations in groundwater were found to be elevated than recommended limits by the World Health Organization. The urinary N-acetyl-h-glucosaminidase values were significantly higher in CKD patients as compared to refrent subjects (p<0.001). The significant variation in levels of Cd and Al were observed in blood samples of CKD patients than referents subjects (p<0.01). The strong positive correlation among Al and Cd levels in groundwater versus blood samples of CKD patients (r=0.82-0.85) p<0.01) was observed than those values calculated for referent subjects (r=0.425-0.536). Copyright © 2016 Elsevier B.V. All rights reserved.

Statistical validation of reagent lot change in the clinical chemistry laboratory can confer insights on good clinical laboratory practice.

PubMed

Cho, Min-Chul; Kim, So Young; Jeong, Tae-Dong; Lee, Woochang; Chun, Sail; Min, Won-Ki

2014-11-01

Verification of new lot reagent's suitability is necessary to ensure that results for patients' samples are consistent before and after reagent lot changes. A typical procedure is to measure results of some patients' samples along with quality control (QC) materials. In this study, the results of patients' samples and QC materials in reagent lot changes were analysed. In addition, the opinion regarding QC target range adjustment along with reagent lot changes was proposed. Patients' sample and QC material results of 360 reagent lot change events involving 61 analytes and eight instrument platforms were analysed. The between-lot differences for the patients' samples (ΔP) and the QC materials (ΔQC) were tested by Mann-Whitney U tests. The size of the between-lot differences in the QC data was calculated as multiples of standard deviation (SD). The ΔP and ΔQC values only differed significantly in 7.8% of the reagent lot change events. This frequency was not affected by the assay principle or the QC material source. One SD was proposed for the cutoff for maintaining pre-existing target range after reagent lot change. While non-commutable QC material results were infrequent in the present study, our data confirmed that QC materials have limited usefulness when assessing new reagent lots. Also a 1 SD standard for establishing a new QC target range after reagent lot change event was proposed. © The Author(s) 2014 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.

Microbiology of peritonsillar abscess in the South Estonian population

PubMed Central

Vaikjärv, Risto; Kasenõmm, Priit; Jaanimäe, Liis; Kivisild, Ave; Rööp, Tiiu; Sepp, Epp; Mändar, Reet

2016-01-01

Objective The first aim of this study was to compare the microbiota of different locations (pus, tonsillar fossa, blood) in peritonsillar abscess (PTA) patients in order to optimize the sampling scheme. The second aim was to estimate the occurrence of tonsillitis episodes and macroscopic oropharyngeal signs characteristic of recurrent tonsillitis in PTA patients. Methods The study group consisted of 22 consecutive patients with PTA undergoing bilateral tonsillectomy. The PTA was punctured; pus and tonsillar fossa biopsy samples and the peripheral blood cultures were collected. The index of tonsillitis was calculated by multiplying the number of tonsillitis episodes per year by the morbidity period in years. Macroscopic oropharyngeal signs were evaluated and they were as follows: tonsillar sclerosis, obstruction of the tonsillar crypts, scar tissue on tonsils, cryptic debris, and lymphatic tissue aggregates. Results The cultures of the pus were positive in 16 out of 22 patients and the cultures of the tonsillar fossa samples were positive in all cases. In total, 62 different organisms were found from tonsillar fossa, pus, and blood samples, which belonged to 5 different phyla and 18 different families. In the tonsillar fossa, the most frequent bacteria found were Streptococcus spp. In pus samples, the most frequently found bacteria were Streptococcus spp. and bacteria from the Streptococcus milleri group. Conclusion PTA patients had mixed anaerobic and aerobic microbiota both in the tissue of the tonsillar fossa and the pus of the peritonsillar space. We demonstrated that the tonsillar fossa specimen is a better material for microbiological analyses, because it reveals more bacteria per culture. PTA patients usually have a low number of tonsillitis episodes in their previous history, but a relatively high number of macroscopic oropharyngeal signs, indicating the sclerotic process in palatal tonsils. PMID:27113570

A Novel Method of Adrenal Venous Sampling via an Antecubital Approach

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

Jiang, Xiongjing, E-mail: jxj103@hotmail.com; Dong, Hui; Peng, Meng

PurposeCurrently, almost all adrenal venous sampling (AVS) procedures are performed by femoral vein access. The purpose of this study was to establish the technique of AVS via an antecubital approach and evaluate its safety and feasibility.Materials and MethodsFrom January 2012 to June 2015, 194 consecutive patients diagnosed as primary aldosteronism underwent AVS via an antecubital approach without ACTH simulation. Catheters used for bilateral adrenal cannulations were recorded. The success rate of bilateral adrenal sampling, operation time, fluoroscopy time, dosage of contrast, and incidence of complications were calculated.ResultsA 5F MPA1 catheter was first used to attempt right adrenal cannulation in all patients.more » Cannulation of the right adrenal vein was successfully performed in 164 (84.5%) patients. The 5F JR5, Cobra2, and TIG catheters were the ultimate catheters for right adrenal cannulation in 16 (8.2%), 5 (2.6%), and 9 (4.6%) patients, respectively. For left adrenal cannulation, JR5 and Cobra2 catheters were used in 19 (9.8%) and 10 (5.2%) patients, respectively, while only TIG catheters were used in the remaining 165 (85.1%) patients. The rate of successful adrenal sampling on the right, left, and bilateral sides was 91.8%, 93.3%, and 87.6%, respectively. The mean time of operation was (16.3 ± 4.3) minutes, mean fluoroscopy time was (4.7 ± 1.3) minutes, and the mean use of contrast was (14.3 ± 4.7) ml. The incidence of adrenal hematoma was 1.0%.ConclusionsThis study showed that AVS via an antecubital approach was safe and feasible, with a high rate of successful sampling.« less

Patient communication self-efficacy, self-reported illness symptoms, physician communication style and mental health and illness in hospital outpatients.

PubMed

Capone, Vincenza

2016-07-01

In this cross-sectional study, we investigated the associations between patient communication self-efficacy and self-reported symptoms in doctor-patient communication, as perceived by patients, and the mental health and illness of hospital outpatients. Using data from a sample of 74 outpatients (mean age = 37.58 years, standard deviation = 12.54), a structural equation model was calculated. The results showed that communication self-efficacy and respectful behaviour were associated with mental health and illness. Furthermore, self-reported symptoms were correlated with mental illness. Gender and educational differences also occurred. The findings suggest that enhancing patients' communication skills could benefit outpatients in general, but female and less educated patients in particular. © The Author(s) 2014.

Assessment of glucocorticoid therapy with salivary cortisol in secondary adrenal insufficiency.

PubMed

Ceccato, Filippo; Albiger, Nora; Reimondo, Giuseppe; Frigo, Anna Chiara; Ferasin, Sergio; Occhi, Gianluca; Mantero, Franco; Terzolo, Massimo; Scaroni, Carla

2012-12-01

Appropriate glucocorticoid replacement therapy in adrenal insufficiency (AI) is crucial, given the risks of chronic under- or overtreatment, particularly in patients on multiple medications. Salivary sampling allows for non-invasive, stress-free cortisol measurement. To determine whether salivary cortisol measurement is helpful in assessing the adequacy of glucocorticoid therapy with cortisone acetate (CA) in patients with secondary AI. A prospective cohort study at the Endocrinology Unit of Padua University Hospital. Six samples of salivary cortisol were collected from 28 patients with secondary AI on CA treatment and from 36 healthy volunteers at fixed times of the day, and used to calculate salivary cortisol levels at each time point and the area under the curve (AUC) across the different sampling times. Salivary cortisol levels were lower in patients than in controls in the morning but no differences were found in the afternoon or at night before resting. Salivary cortisol levels were higher in patients immediately following CA administration. Ten patients showed an AUC above the 97.5th percentile of controls, without clinical signs of hypercortisolism, and salivary cortisol levels 90 min after each dose of CA predict the AUC. All patients had severe GH deficiency and there were no differences in salivary cortisol levels or AUC between patients treated or not with GH. Two salivary cortisol determinations, able to predict the daily AUC, may allow for assessing the adequacy of glucocorticoid replacement therapy in secondary AI and for identifying cases of over- or undertreatment.

Effect of age on survival benefit of adjuvant chemotherapy in elderly patients with Stage III colon cancer.

PubMed

Zuckerman, Ilene H; Rapp, Thomas; Onukwugha, Ebere; Davidoff, Amy; Choti, Michael A; Gardner, James; Seal, Brian; Mullins, C Daniel

2009-08-01

To estimate the modifying effect of age on the survival benefit associated with adjuvant chemotherapy receipt in elderly patients with a diagnosis of Stage III colon cancer. Observational, retrospective cohort study using two samples: an overall sample of 7,182 patients to provide externally valid analyses and a propensity score-matched sample of 3,016 patients to provide more internally valid analyses by reducing the presence of treatment endogeneity. An interval-censored survival model with a complementary log-log link was used. Hazard ratios and 95% confidence intervals were obtained for all regressions. Data from the National Cancer Institute's Surveillance, Epidemiology and End Results database and the linked Medicare enrollment and claims database were used. Selected patients were aged 66 and older and had a diagnosis of Stage III colon cancer. Patients were followed from surgery to time of death or censorship. The outcome was colon cancer-specific death during the follow-up period. Receipt of adjuvant chemotherapy was measured according to the presence of a claim for 5-fluorouracil or leucovorin within 6 months after surgery. All elderly patients had a significant survival benefit associated with adjuvant chemotherapy receipt, although the survival benefit of adjuvant chemotherapy was not uniform across all age groups. These findings have important clinical and policy implications for the risk-benefit calculation induced by treatment in older patients with Stage III colon cancer. The results suggest that there is a benefit from chemotherapy, but the benefit is lower with older age.

[The alpha-fetoprotein in prognosis of survival of and functional rehabilitation of patients with ischemic stroke].

PubMed

Arkhipkin, A A; Liang, O V; Kochetov, A G

2014-10-01

The study was carried out to determine the prognostic value of alpha-fetoprotein in development of lethal outcome and degree of functional rehabilitation of patients with ischemic stroke. The sampling included 216 patients in acute period of ischemic stroke. At the first day of development of disease they were measured the level of human alpha-fetoprotein. At the second day of disease patients were evaluated the degree of functional rehabilitation and the rate of lethal outcomes was calculated. Previously, the reference interval for alpha-fetoprotein was calculated according the guidelines of the International federation of clinical chemistry and national standard. The reference interval amounted to 0.59-3.78 mE/l. The study results demonstrated that low level of alpha-fetoprotein is related to higher risk of lethal outcome (SE=1.7, p=0.012). The increasing of level of alpha-fetoprotein over mentioned threshold value statistically significant increases probability of survival of patients. The further increasing more than 2.28 mE/l is related to subsequent good functional rehabilitation according the modifies Rankine scale (SE=1.4, p=0.001) and Barthel index (SE=1.49, p<0.001).

Evaluation of salivary melatonin measurements for Dim Light Melatonin Onset calculations in patients with possible sleep-wake rhythm disorders.

PubMed

Keijzer, Henry; Smits, Marcel G; Peeters, Twan; Looman, Caspar W N; Endenburg, Silvia C; Gunnewiek, Jacqueline M T Klein

2011-08-17

Dim Light Melatonin Onset (DLMO) can be calculated within a 5-point partial melatonin curve in saliva collected at home. We retrospectively analyzed the patient melatonin measurements sample size of the year 2008 to evaluate these DLMO calculations and studied the correlation between diary or polysomnography (PSG) sleep onset and DLMO. Patients completed an online questionnaire. If this questionnaire pointed to a possible Delayed Sleep Phase Disorder (DSPD), saliva collection devices were sent to the patient. Collection occurred at 5 consecutive hours. Melatonin concentration was measured with a radioimmunoassay and DLMO was defined as the time at which the melatonin concentration in saliva reaches 4 pg/mL. Sleep onset time was retrieved from an online one-week sleep diary and/or one-night PSG. A total of 1848 diagnostic 5-point curves were obtained. DLMO could be determined in 76.2% (n=1408). DLMO significantly differed between different age groups and increased with age. Pearson correlations (r) between DLMO and sleep onset measured with PSG or with a diary were 0.514 (p=<0.001, n=54) and 0.653 (p=0.002, n=20) respectively. DLMO can be reliably measured in saliva that is conveniently collected at home. DLMO correlates moderately with sleep onset. Copyright © 2011 Elsevier B.V. All rights reserved.

Accounting for twin births in sample size calculations for randomised trials.

PubMed

Yelland, Lisa N; Sullivan, Thomas R; Collins, Carmel T; Price, David J; McPhee, Andrew J; Lee, Katherine J

2018-05-04

Including twins in randomised trials leads to non-independence or clustering in the data. Clustering has important implications for sample size calculations, yet few trials take this into account. Estimates of the intracluster correlation coefficient (ICC), or the correlation between outcomes of twins, are needed to assist with sample size planning. Our aims were to provide ICC estimates for infant outcomes, describe the information that must be specified in order to account for clustering due to twins in sample size calculations, and develop a simple tool for performing sample size calculations for trials including twins. ICCs were estimated for infant outcomes collected in four randomised trials that included twins. The information required to account for clustering due to twins in sample size calculations is described. A tool that calculates the sample size based on this information was developed in Microsoft Excel and in R as a Shiny web app. ICC estimates ranged between -0.12, indicating a weak negative relationship, and 0.98, indicating a strong positive relationship between outcomes of twins. Example calculations illustrate how the ICC estimates and sample size calculator can be used to determine the target sample size for trials including twins. Clustering among outcomes measured on twins should be taken into account in sample size calculations to obtain the desired power. Our ICC estimates and sample size calculator will be useful for designing future trials that include twins. Publication of additional ICCs is needed to further assist with sample size planning for future trials. © 2018 John Wiley & Sons Ltd.

The cost of colorectal cancer according to the TNM stage.

PubMed

Mar, Javier; Errasti, Jose; Soto-Gordoa, Myriam; Mar-Barrutia, Gilen; Martinez-Llorente, José Miguel; Domínguez, Severina; García-Albás, Juan José; Arrospide, Arantzazu

2017-02-01

The aim of this study was to measure the cost of treatment of colorectal cancer in the Basque public health system according to the clinical stage. We retrospectively collected demographic data, clinical data and resource use of a sample of 529 patients. For stagesi toiii the initial and follow-up costs were measured. The calculation of cost for stageiv combined generalized linear models to relate the cost to the duration of follow-up based on parametric survival analysis. Unit costs were obtained from the analytical accounting system of the Basque Health Service. The sample included 110 patients with stagei, 171 with stageii, 158 with stageiii and 90 with stageiv colorectal cancer. The initial total cost per patient was 8,644€ for stagei, 12,675€ for stageii and 13,034€ for stageiii. The main component was hospitalization cost. Calculated by extrapolation for stageiv mean survival was 1.27years. Its average annual cost was 22,403€, and 24,509€ to death. The total annual cost for colorectal cancer extrapolated to the whole Spanish health system was 623.9million€. The economic burden of colorectal cancer is important and should be taken into account in decision-making. The combination of generalized linear models and survival analysis allows estimation of the cost of metastatic stage. Copyright © 2017 AEC. Publicado por Elsevier España, S.L.U. All rights reserved.

Genome Wide Association Study to Identify SNPs and CNPs Associated with Development of Radiation Injury in Prostate Cancer Patients Treated With Radiotherapy

DTIC Science & Technology

2010-10-01

reproducibility of genotype c alls among the four batches by comparing the HapMap samples across batches. We also calculated identity-by- descent (IBD...used to aid clinicians in per sonalizing dosage to improve the therapeutic index of radiotherapy treatment for prostate cancer. References None Appendices None

Genome Wide Association Study to Identify SNPs and CNPs Associated with Development of Radiation Injury in Prostate Cancer Patients Treated with Radiotherapy

DTIC Science & Technology

2011-10-01

the HapMap samples across batches. We also calculated identity-by- descent (IBD) and identity-by-state (IBS) measures to confirm the identity of the...development of adverse events following radiotherapy. Such a tool could be used to aid clinicians in personalizing dosage to improve the therapeutic index of

Fetal blood drawing.

PubMed

Hobbins, J C; Mahoney, M J

1975-07-19

A small sample of fetal blood suitable for studies of haemoglobin synthesis was obtained from a placental vessel under endoscopic visualisation in 23 of 26 patients in whom the procedure was attempted prior to second-trimester abortion. Fetal blood loss, calculated in 23 cases, was between 0-2 ml. and 2-5 ml., and fetal blood-volume depletion varied from 0-5% to 15%. No short-term ill-effects were demonstrated in mother or fetus in any of 16 patients in whom the injection of aborti-facient was postponed for between 16 and 24 hours after the procedure.

Comparison of SHOX and associated elements duplications distribution between patients (Lėri-Weill dyschondrosteosis/idiopathic short stature) and population sample.

PubMed

Hirschfeldova, Katerina; Solc, Roman

2017-09-05

The effect of heterozygous duplications of SHOX and associated elements on Lėri-Weill dyschondrosteosis (LWD) and idiopathic short stature (ISS) development is less distinct when compared to reciprocal deletions. The aim of our study was to compare frequency and distribution of duplications within SHOX and associated elements between population sample and LWD (ISS) patients. A preliminary analysis conducted on Czech population sample of 250 individuals compared to our previously reported sample of 352 ISS/LWD Czech patients indicated that rather than the difference in frequency of duplications it is the difference in their distribution. Particularly, there was an increased frequency of duplications residing to the CNE-9 enhancer in our LWD/ISS sample. To see whether the obtained data are consistent across published studies we made a literature survey to get published cases with SHOX or associated elements duplication and formed the merged LWD, the merged ISS, and the merged population samples. Relative frequency of particular region duplication in each of those merged samples were calculated. There was a significant difference in the relative frequency of CNE-9 enhancer duplications (11 vs. 3) and complete SHOX (exon1-6b) duplications (4 vs. 24) (p-value 0.0139 and p-value 0.000014, respectively) between the merged LWD sample and the merged population sample. We thus propose that partial SHOX duplications and small duplications encompassing CNE-9 enhancer could be highly penetrant alleles associated with ISS and LWD development. Copyright © 2017 Elsevier B.V. All rights reserved.

Protoporphyrin IX induced by 5-aminolevulinic acid in bladder cancer cells in voided urine can be extracorporeally quantified using a spectrophotometer.

PubMed

Nakai, Yasushi; Anai, Satoshi; Onishi, Sayuri; Masaomi, Kuwada; Tatsumi, Yoshihiro; Miyake, Makito; Chihara, Yoshitomo; Tanaka, Nobumichi; Hirao, Yoshihiko; Fujimoto, Kiyohide

2015-06-01

We evaluated the feasibility of photodynamic diagnosis of bladder cancer by spectrophotometric analysis of voided urine samples after extracorporeal treatment with 5-aminolevulinic acid (ALA). Sixty-one patients with bladder cancer, confirmed histologically after the transurethral resection of a bladder tumor, were recruited as the bladder cancer group, and 50 outpatients without history of urothelial carcinoma or cancer-related findings were recruited as the control group. Half of the voided urine sample was incubated with ALA (ALA-treated sample), and the rest was incubated without treatment (ALA-untreated sample). For detecting cellular protoporphyrin IX levels, intensity of the samples at the excitation wavelength of 405 nm was measured using a spectrophotometer. The difference between the intensity of the ALA-treated and ALA-untreated samples at 635 nm was calculated. The differences in the bladder cancer group were significantly greater than those in the control group (p < 0.001). These differences were also significantly greater in patients with high-grade tumors than in those with low-grade tumors (p = 0.004), and also in patients with invasive bladder cancer than in those with noninvasive bladder cancer (p = 0.007). The area under the curve was 0.84. Sensitivity and specificity of the method were 82% and 80%, respectively. We demonstrated that protoporphyrin IX levels in urinary cells treated with ALA could be quantitatively detected by spectrophotometer in patients with bladder cancer. Therefore, this cancer detection system has a potential for clinical use. Copyright © 2015 Elsevier B.V. All rights reserved.

Evaluation of anti-microbial activity of spore powder of Ganoderma lucidum on clinical isolates of Prevotella intermedia: A pilot study.

PubMed

Nayak, Ranganath N; Dixitraj, P T; Nayak, Aarati; Bhat, Kishore

2015-09-01

This study aimed at evaluating the anti-microbial activity of spore powder of Ganoderma lucidum on Prevotella intermedia isolated from subgingival plaque from chronic periodontitis patients. Written informed consent was obtained from each subject enrolled in the study. The Institutional Ethics Committee granted the ethical clearance for the study. This study included 20 patients diagnosed with chronic periodontitis. Pooled subgingival plaque samples were collected using sterile curettes from the deepest sites of periodontal pockets. The collected samples were then transported in 1 mL of reduced transport fluid. The organisms were cultured and confirmed. These organisms were then used for minimum inhibitory concentration (MIC) procedure. Mean of the MIC value obtained was calculated. Thirteen out of the 20 clinical samples were tested that showed sensitivity at various concentrations. Five samples showed sensitivity at all concentrations. Twelve samples showed sensitivity at 8 mcg/ml. Eleven samples showed sensitivity at 4 mcg/ml, 8 samples showed sensitivity at 2 mcg/ml, and 5 samples showed sensitivity even at 1 mcg/ml. Mean MIC value of G. lucidum spore powder for P. intermedia obtained was 3.62 mcg/ml. G. lucidum with its multipotential bioactivity could be used as an anti-microbial, in conjunction with conventional therapy in periodontal disease.

Sample size calculations for randomized clinical trials published in anesthesiology journals: a comparison of 2010 versus 2016.

PubMed

Chow, Jeffrey T Y; Turkstra, Timothy P; Yim, Edmund; Jones, Philip M

2018-06-01

Although every randomized clinical trial (RCT) needs participants, determining the ideal number of participants that balances limited resources and the ability to detect a real effect is difficult. Focussing on two-arm, parallel group, superiority RCTs published in six general anesthesiology journals, the objective of this study was to compare the quality of sample size calculations for RCTs published in 2010 vs 2016. Each RCT's full text was searched for the presence of a sample size calculation, and the assumptions made by the investigators were compared with the actual values observed in the results. Analyses were only performed for sample size calculations that were amenable to replication, defined as using a clearly identified outcome that was continuous or binary in a standard sample size calculation procedure. The percentage of RCTs reporting all sample size calculation assumptions increased from 51% in 2010 to 84% in 2016. The difference between the values observed in the study and the expected values used for the sample size calculation for most RCTs was usually > 10% of the expected value, with negligible improvement from 2010 to 2016. While the reporting of sample size calculations improved from 2010 to 2016, the expected values in these sample size calculations often assumed effect sizes larger than those actually observed in the study. Since overly optimistic assumptions may systematically lead to underpowered RCTs, improvements in how to calculate and report sample sizes in anesthesiology research are needed.

Design of the value of imaging in enhancing the wellness of your heart (VIEW) trial and the impact of uncertainty on power.

PubMed

Ambrosius, Walter T; Polonsky, Tamar S; Greenland, Philip; Goff, David C; Perdue, Letitia H; Fortmann, Stephen P; Margolis, Karen L; Pajewski, Nicholas M

2012-04-01

Although observational evidence has suggested that the measurement of coronary artery calcium (CAC) may improve risk stratification for cardiovascular events and thus help guide the use of lipid-lowering therapy, this contention has not been evaluated within the context of a randomized trial. The Value of Imaging in Enhancing the Wellness of Your Heart (VIEW) trial is proposed as a randomized study in participants at low intermediate risk of future coronary heart disease (CHD) events to evaluate whether CAC testing leads to improved patient outcomes. To describe the challenges encountered in designing a prototypical screening trial and to examine the impact of uncertainty on power. The VIEW trial was designed as an effectiveness clinical trial to examine the benefit of CAC testing to guide therapy on a primary outcome consisting of a composite of nonfatal myocardial infarction, probable or definite angina with revascularization, resuscitated cardiac arrest, nonfatal stroke (not transient ischemic attack (TIA)), CHD death, stroke death, other atherosclerotic death, or other cardiovascular disease (CVD) death. Many critical choices were faced in designing the trial, including (1) the choice of primary outcome, (2) the choice of therapy, (3) the target population with corresponding ethical issues, (4) specifications of assumptions for sample size calculations, and (5) impact of uncertainty in these assumptions on power/sample size determination. We have proposed a sample size of 30,000 (800 events), which provides 92.7% power. Alternatively, sample sizes of 20,228 (539 events), 23,138 (617 events), and 27,078 (722 events) provide 80%, 85%, and 90% power. We have also allowed for uncertainty in our assumptions by computing average power integrated over specified prior distributions. This relaxation of specificity indicates a reduction in power, dropping to 89.9% (95% confidence interval (CI): 89.8-89.9) for a sample size of 30,000. Samples sizes of 20,228, 23,138, and 27,078 provide power of 78.0% (77.9-78.0), 82.5% (82.5-82.6), and 87.2% (87.2-87.3), respectively. These power estimates are dependent on form and parameters of the prior distributions. Despite the pressing need for a randomized trial to evaluate the utility of CAC testing, conduct of such a trial requires recruiting a large patient population, making efficiency of critical importance. The large sample size is primarily due to targeting a study population at relatively low risk of a CVD event. Our calculations also illustrate the importance of formally considering uncertainty in power calculations of large trials as standard power calculations may tend to overestimate power.

Design of the Value of Imaging in Enhancing the Wellness of Your Heart (VIEW) Trial and the Impact of Uncertainty on Power

PubMed Central

Ambrosius, Walter T.; Polonsky, Tamar S.; Greenland, Philip; Goff, David C.; Perdue, Letitia H.; Fortmann, Stephen P.; Margolis, Karen L.; Pajewski, Nicholas M.

2014-01-01

Background Although observational evidence has suggested that the measurement of CAC may improve risk stratification for cardiovascular events and thus help guide the use of lipid-lowering therapy, this contention has not been evaluated within the context of a randomized trial. The Value of Imaging in Enhancing the Wellness of Your Heart (VIEW) trial is proposed as a randomized study in participants at low intermediate risk of future coronary heart disease (CHD) events to evaluate whether coronary artery calcium (CAC) testing leads to improved patient outcomes. Purpose To describe the challenges encountered in designing a prototypical screening trial and to examine the impact of uncertainty on power. Methods The VIEW trial was designed as an effectiveness clinical trial to examine the benefit of CAC testing to guide therapy on a primary outcome consisting of a composite of non-fatal myocardial infarction, probable or definite angina with revascularization, resuscitated cardiac arrest, non-fatal stroke (not transient ischemic attack (TIA)), CHD death, stroke death, other atherosclerotic death, or other cardiovascular disease (CVD) death. Many critical choices were faced in designing the trial, including: (1) the choice of primary outcome, (2) the choice of therapy, (3) the target population with corresponding ethical issues, (4) specifications of assumptions for sample size calculations, and (5) impact of uncertainty in these assumptions on power/sample size determination. Results We have proposed a sample size of 30,000 (800 events) which provides 92.7% power. Alternatively, sample sizes of 20,228 (539 events), 23,138 (617 events) and 27,078 (722 events) provide 80, 85, and 90% power. We have also allowed for uncertainty in our assumptions by computing average power integrated over specified prior distributions. This relaxation of specificity indicates a reduction in power, dropping to 89.9% (95% confidence interval (CI): 89.8 to 89.9) for a sample size of 30,000. Samples sizes of 20,228, 23,138, and 27,078 provide power of 78.0% (77.9 to 78.0), 82.5% (82.5 to 82.6), and 87.2% (87.2 to 87.3), respectively. Limitations These power estimates are dependent on form and parameters of the prior distributions. Conclusions Despite the pressing need for a randomized trial to evaluate the utility of CAC testing, conduct of such a trial requires recruiting a large patient population, making efficiency of critical importance. The large sample size is primarily due to targeting a study population at relatively low risk of a CVD event. Our calculations also illustrate the importance of formally considering uncertainty in power calculations of large trials as standard power calculations may tend to overestimate power. PMID:22333998

Measurement of daily sodium excretion in patients with chronic kidney disease; special reference to the difference between the amount measured from 24 h collected urine sample and the estimated amount from a spot urine.

PubMed

Amano, Hoichi; Kobayashi, Seiji; Terawaki, Hiroyuki; Ogura, Makoto; Kawaguchi, Yoshindo; Yokoo, Takashi

2018-11-01

It is important to grasp a patient's daily sodium intake in the management of chronic kidney disease, as sodium intake is widely recommended at 6 g/day or less. There are multiple equations widely known for estimating the daily sodium excretion from a spot urine sample, but these are aimed at healthy people. There are few reports that validate equations in patients with chronic kidney disease. The purpose of this study is to evaluate whether the amount of measured daily sodium excretion from a sample collected for 24-h urine (24HU) is equal to that of using an equation from a spot urine sample (SU) in patients with chronic kidney disease. One hundred sixty-two patients with chronic kidney disease from Kanagawa Prefecture Shiomidai Hospital, Japan and the Jikei University Kashiwa Hospital, Japan participated in the study. Daily sodium excretion was measured from 24HU and compared with it from SU by using the formula according to Tanaka et al. Sodium excretion by 24HU was 2744 mg/day and estimating daily sodium excretion from SU was 3315 mg/day. The coefficient of determination was 0.17 (p < .001) in multivariate regression analysis. The coefficient of determination was extremely low. Thus, there is a considerable difference between the amount of sodium excretion calculated from a 24HU and that from a SU in patients with chronic kidney disease.

Cancer protection elicited by a single nucleotide polymorphism close to the adrenomedullin gene.

PubMed

Martínez-Herrero, Sonia; Martínez, Alfredo

2013-04-01

The risk of developing cancer is regulated by genetic variants, including polymorphisms. Characterizing such variants may help in developing protocols for personalized medicine. Adrenomedullin is a regulatory peptide involved in cancer promotion and progression. Carriers of a single nucleotide polymorphism (SNP) in the proximity of the adrenomedullin gene have lower levels of circulating peptide. The aim of the present work was to investigate whether carriers of this SNP (rs4910118) are protected against cancer. This was a retrospective study. DNA samples were obtained from the Carlos III DNA National Bank (University of Salamanca, Salamanca, Spain). Samples represent a variety of donors and patients from Spain. DNA from patients with breast cancer (n = 238), patients with lung cancer (n = 348), patients with cardiac insufficiency (n = 474), and healthy donors of advanced age (n = 500) was used. All samples were genotyped using double-mismatch PCR, and confirmation was achieved by direct sequencing. The minor allele frequency was calculated in all groups. The Pearson χ(2) was used to compare SNP frequencies. Of 1560 samples, 14 had the minor allele, with a minor allele frequency in healthy donors of 0.90%. Patients with cancer had a statistically significantly lower frequency than healthy donors (odds ratio = 0.216, 95% confidence interval = 0.048-0.967, P = .028). Carriers of the minor allele have a 4.6-fold lower risk of developing cancer than homozygotes for the major allele. Knowledge of the rs4910118 genotype may be useful for stratifying patients in clinical trials and for designing prevention strategies.

Evaluation of bilirubin concentration in hemolysed samples, is it really impossible? The altitude-curve cartography approach to interfered assays.

PubMed

Brunori, Paola; Masi, Piergiorgio; Faggiani, Luigi; Villani, Luciano; Tronchin, Michele; Galli, Claudio; Laube, Clarissa; Leoni, Antonella; Demi, Maila; La Gioia, Antonio

2011-04-11

Neonatal jaundice might lead to severe clinical consequences. Measurement of bilirubin in samples is interfered by hemolysis. Over a method-depending cut-off value of measured hemolysis, bilirubin value is not accepted and a new sample is required for evaluation although this is not always possible, especially with newborns and cachectic oncological patients. When usage of different methods, less prone to interferences, is not feasible an alternative recovery method for analytical significance of rejected data might help clinicians to take appropriate decisions. We studied the effects of hemolysis over total bilirubin measurement, comparing hemolysis-interfered bilirubin measurement with the non-interfered value. Interference curves were extrapolated over a wide range of bilirubin (0-30 mg/mL) and hemolysis (H Index 0-1100). Interference "altitude" curves were calculated and plotted. A bimodal acceptance table was calculated. Non-interfered bilirubin of given samples was calculated, by linear interpolation between the nearest lower and upper interference curves. Rejection of interference-sensitive data from hemolysed samples for every method should be based not upon the interferent concentration but upon a more complex algorithm based upon the concentration-dependent bimodal interaction between the interfered analyte and the measured interferent. The altitude-curve cartography approach to interfered assays may help laboratories to build up their own method-dependent algorithm and to improve the trueness of their data by choosing a cut-off value different from the one (-10% interference) proposed by manufacturers. When re-sampling or an alternative method is not available the altitude-curve cartography approach might also represent an alternative recovery method for analytical significance of rejected data. Copyright © 2011 Elsevier B.V. All rights reserved.

Concurrent validity and interrater reliability of a new smartphone application to assess 3D active cervical range of motion in patients with neck pain.

PubMed

Stenneberg, Martijn S; Busstra, Harm; Eskes, Michel; van Trijffel, Emiel; Cattrysse, Erik; Scholten-Peeters, Gwendolijne G M; de Bie, Rob A

2018-04-01

There is a lack of valid, reliable, and feasible instruments for measuring planar active cervical range of motion (aCROM) and associated 3D coupling motions in patients with neck pain. Smartphones have advanced sensors and appear to be suitable for these measurements. To estimate the concurrent validity and interrater reliability of a new iPhone application for assessing planar aCROM and associated 3D coupling motions in patients with neck pain, using an electromagnetic tracking device as a reference test. Cross-sectional study. Two samples of neck pain patients were recruited; 30 patients for the validity study and 26 patients for the reliability study. Validity was estimated using intraclass correlation coefficients (ICCs), and by calculating 95% limits of agreement (LoA). To estimate interrater reliability, ICCs were calculated. Cervical 3D coupling motions were analyzed by calculating the cross-correlation coefficients and ratio between the main motions and coupled motions for both instruments. ICCs for concurrent validity and interrater reliability ranged from 0.90 to 0.99. The width of the 95% LoA ranged from about 5° for right lateral bending to 11° for total rotation. No significant differences were found between both devices for associated coupling motion analysis. The iPhone application appears to be a useful discriminative tool for the measurement of planar aCROM and associated coupling motions in patients with neck pain. It fulfills the need for a valid, reliable, and feasible instrument in clinical practice and research. Therapists and researchers should consider measurement error when interpreting scores. Copyright © 2017 Elsevier Ltd. All rights reserved.

Characterization of Free Phenytoin Concentrations in End-Stage Renal Disease Using the Winter-Tozer Equation.

PubMed

Soriano, Vincent V; Tesoro, Eljim P; Kane, Sean P

2017-08-01

The Winter-Tozer (WT) equation has been shown to reliably predict free phenytoin levels in healthy patients. In patients with end-stage renal disease (ESRD), phenytoin-albumin binding is altered and, thus, affects interpretation of total serum levels. Although an ESRD WT equation was historically proposed for this population, there is a lack of data evaluating its accuracy. The objective of this study was to determine the accuracy of the ESRD WT equation in predicting free serum phenytoin concentration in patients with ESRD on hemodialysis (HD). A retrospective analysis of adult patients with ESRD on HD and concurrent free and total phenytoin concentrations was conducted. Each patient's true free phenytoin concentration was compared with a calculated value using the ESRD WT equation and a revised version of the ESRD WT equation. A total of 21 patients were included for analysis. The ESRD WT equation produced a percentage error of 75% and a root mean square error of 1.76 µg/mL. Additionally, 67% of the samples had an error >50% when using the ESRD WT equation. A revised equation was found to have high predictive accuracy, with only 5% of the samples demonstrating >50% error. The ESRD WT equation was not accurate in predicting free phenytoin concentration in patients with ESRD on HD. A revised ESRD WT equation was found to be significantly more accurate. Given the small study sample, further studies are required to fully evaluate the clinical utility of the revised ESRD WT equation.

The UK Quality and Outcomes Framework pay-for-performance scheme and spirometry: rewarding quality or just quantity? A cross-sectional study in Rotherham, UK

PubMed Central

Strong, Mark; South, Gail; Carlisle, Robin

2009-01-01

Background Accurate spirometry is important in the management of COPD. The UK Quality and Outcomes Framework pay-for-performance scheme for general practitioners includes spirometry related indicators within its COPD domain. It is not known whether high achievement against QOF spirometry indicators is associated with spirometry to BTS standards. Methods Data were obtained from the records of 3,217 patients randomly sampled from 5,649 patients with COPD in 38 general practices in Rotherham, UK. Severity of airflow obstruction was categorised by FEV1 (% predicted) according to NICE guidelines. This was compared with clinician recorded COPD severity. The proportion of patients whose spirometry met BTS standards was calculated in each practice using a random sub-sample of 761 patients. The Spearman rank correlation between practice level QOF spirometry achievement and performance against BTS spirometry standards was calculated. Results Spirometry as assessed by clinical records was to BTS standards in 31% of cases (range at practice level 0% to 74%). The categorisation of airflow obstruction according to the most recent spirometry results did not agree well with the clinical categorisation of COPD recorded in the notes (Cohen's kappa = 0.34, 0.30 – 0.38). 12% of patients on COPD registers had FEV1 (% predicted) results recorded that did not support the diagnosis of COPD. There was no association between quality, as measured by adherence to BTS spirometry standards, and either QOF COPD9 achievement (Spearman's rho = -0.11), or QOF COPD10 achievement (rho = 0.01). Conclusion The UK Quality and Outcomes Framework currently assesses the quantity, but not the quality of spirometry. PMID:19558719

The UK Quality and Outcomes Framework pay-for-performance scheme and spirometry: rewarding quality or just quantity? A cross-sectional study in Rotherham, UK.

PubMed

Strong, Mark; South, Gail; Carlisle, Robin

2009-06-28

Accurate spirometry is important in the management of COPD. The UK Quality and Outcomes Framework pay-for-performance scheme for general practitioners includes spirometry related indicators within its COPD domain. It is not known whether high achievement against QOF spirometry indicators is associated with spirometry to BTS standards. Data were obtained from the records of 3,217 patients randomly sampled from 5,649 patients with COPD in 38 general practices in Rotherham, UK. Severity of airflow obstruction was categorised by FEV1 (% predicted) according to NICE guidelines. This was compared with clinician recorded COPD severity. The proportion of patients whose spirometry met BTS standards was calculated in each practice using a random sub-sample of 761 patients. The Spearman rank correlation between practice level QOF spirometry achievement and performance against BTS spirometry standards was calculated. Spirometry as assessed by clinical records was to BTS standards in 31% of cases (range at practice level 0% to 74%). The categorisation of airflow obstruction according to the most recent spirometry results did not agree well with the clinical categorisation of COPD recorded in the notes (Cohen's kappa = 0.34, 0.30 - 0.38). 12% of patients on COPD registers had FEV1 (% predicted) results recorded that did not support the diagnosis of COPD. There was no association between quality, as measured by adherence to BTS spirometry standards, and either QOF COPD9 achievement (Spearman's rho = -0.11), or QOF COPD10 achievement (rho = 0.01). The UK Quality and Outcomes Framework currently assesses the quantity, but not the quality of spirometry.

The photographic knee pain map: locating knee pain with an instrument developed for diagnostic, communication and research purposes.

PubMed

Elson, D W; Jones, S; Caplan, N; Stewart, S; St Clair Gibson, A; Kader, D F

2011-12-01

Pain maps are used to determine the location of pain. Knee pain maps have previously been described, but only one study has reported on reliability and none report validity. The present study describes the generation of a photographic knee pain map (PKPM) together with its validity and reliability. A photographic representation of a pair of knees was chosen by 26 patients, (66.7%) from a group of 39. The selected photograph was modified and a template of anatomical zones was generated. The opinions of 25 independent subject matter experts were canvassed and validity ratios calculated for these zones, ranged from 0.28 to 0.84. Hypothetical comparisons were made between the PKPM and an alternative knee pain map, in a cross-sectional group of 26 patients (35 knees). Convergent patterns of validity were found where hypothesised. Reliability was determined using a different cohort of 44 patients (58 knees) who completed the PKPM before and after a sampling delay. Four of these patients were excluded with a short sampling delay. Calculated agreement of test-retest reproducibility was fair to good. All of the completed PKPM (151 knees) were then subject to further analysis where inter-rater reproducibility was good to very good and intra-rater reproducibility was very good. The PKPM is readily accessible to patients with low completion burden. It is both valid and reliable and we suggest it can be used in both clinical and research settings. Further studies are planned to explore its predictive ability as a diagnostic tool. The PKPM can be found at www.photographickneepainmap.com. Copyright © 2010 Elsevier B.V. All rights reserved.

[Development of ophthalmologic software for handheld devices].

PubMed

Grottone, Gustavo Teixeira; Pisa, Ivan Torres; Grottone, João Carlos; Debs, Fernando; Schor, Paulo

2006-01-01

The formulas for calculation of intraocular lenses have evolved since the first theoretical formulas by Fyodorov. Among the second generation formulas, the SRK-I formula has a simple calculation, taking into account a calculation that only involved anteroposterior length, IOL constant and average keratometry. With the evolution of those formulas, complexicity increased making the reconfiguration of parameters in special situations impracticable. In this way the production and development of software for such a purpose, can help surgeons to recalculate those values if needed. To idealize, develop and test a Brazilian software for calculation of IOL dioptric power for handheld computers. For the development and programming of software for calculation of IOL, we used PocketC program (OrbWorks Concentrated Software, USA). We compared the results collected from a gold-standard device (Ultrascan/Alcon Labs) with the simulation of 100 fictitious patients, using the same IOL parameters. The results were grouped for ULTRASCAN data and SOFTWARE data. Using SRK/T formula the range of those parameters included a keratometry varying between 35 and 55D, axial length between 20 and 28 mm, IOL constants of 118.7, 118.3 and 115.8. Using Wilcoxon test, it was shown that the groups do not differ (p=0.314). We had a variation in the Ultrascan sample between 11.82 and 27.97. In the tested program sample the variation was practically similar (11.83-27.98). The average of the Ultrascan group was 20.93. The software group had a similar average. The standard deviation of the samples was also similar (4.53). The precision of IOL software for handheld devices was similar to that of the standard devices using the SRK/T formula. The software worked properly, was steady without bugs in tested models of operational system.

Case-mix adjustment and the comparison of community health center performance on patient experience measures.

PubMed

Johnson, M Laura; Rodriguez, Hector P; Solorio, M Rosa

2010-06-01

To assess the effect of case-mix adjustment on community health center (CHC) performance on patient experience measures. A Medicaid-managed care plan in Washington State collected patient survey data from 33 CHCs over three fiscal quarters during 2007-2008. The survey included three composite patient experience measures (6-month reports) and two overall ratings of care. The analytic sample includes 2,247 adult patients and 2,859 adults reporting for child patients. We compared the relative importance of patient case-mix adjusters by calculating each adjuster's predictive power and variability across CHCs. We then evaluated the impact of case-mix adjustment on the relative ranking of CHCs. Important case-mix adjusters included adult self-reported health status or parent-reported child health status, adult age, and educational attainment. The effects of case-mix adjustment on patient reports and ratings were different in the adult and child samples. Adjusting for race/ethnicity and language had a greater impact on parent reports than adult reports, but it impacted ratings similarly across the samples. The impact of adjustment on composites and ratings was modest, but it affected the relative ranking of CHCs. To ensure equitable comparison of CHC performance on patient experience measures, reports and ratings should be adjusted for adult self-reported health status or parent-reported child health status, adult age, education, race/ethnicity, and survey language. Because of the differential impact of case-mix adjusters for child and adult surveys, initiatives should consider measuring and reporting adult and child scores separately.

Prevalence and distribution of dental anomalies in orthodontic patients.

PubMed

Montasser, Mona A; Taha, Mahasen

2012-01-01

To study the prevalence and distribution of dental anomalies in a sample of orthodontic patients. The dental casts, intraoral photographs, and lateral panoramic and cephalometric radiographs of 509 Egyptian orthodontic patients were studied. Patients were examined for dental anomalies in number, size, shape, position, and structure. The prevalence of each dental anomaly was calculated and compared between sexes. Of the total study sample, 32.6% of the patients had at least one dental anomaly other than agenesis of third molars; 32.1% of females and 33.5% of males had at least one dental anomaly other than agenesis of third molars. The most commonly detected dental anomalies were impaction (12.8%) and ectopic eruption (10.8%). The total prevalence of hypodontia (excluding third molars) and hyperdontia was 2.4% and 2.8%, respectively, with similiar distributions in females and males. Gemination and accessory roots were reported in this study; each of these anomalies was detected in 0.2% of patients. In addition to genetic and racial factors, environmental factors could have more important influence on the prevalence of dental anomalies in every population. Impaction, ectopic eruption, hyperdontia, hypodontia, and microdontia were the most common dental anomalies, while fusion and dentinogenesis imperfecta were absent.

Quantification of taurodontism: interests in the early diagnosis of hypohidrotic ectodermal dysplasia.

PubMed

Gros, C-I; Clauss, F; Obry, F; Manière, M C; Schmittbuhl, M

2010-04-01

The aim of this study was to provide a quantification of taurodontism in Hypohidrotic Ectodermal Dysplasia (HED) and to report its occurrence in a cohort of HED patients to assess phenotypic-genotypic correlations. Of 68 HED patients retrospectively reviewed, 16 patients aged 7-51 years were selected and compared with a control sample (n = 351). The pulp surface index of the first lower permanent molar was calculated from the panoramic radiograph of each individual, and statistical comparisons between the HED patients and the control sample were performed. Whatever the genetic disorder, 81.25% of the HED patients exhibited a relative enlargement (>or=1 s.d.) of the pulp. Major deviations (>5 s.d.) were respectively related to men affected by large deletion of the EDA gene or missense mutation. The autosomal recessive form was linked to a relative moderate pulp enlargement (3.44 s.d.). In NEMO forms, the increase of pulp size in men appeared to be less marked than in EDA mutations. This study provides for the first time an objective assessment of pulp enlargement in HED patients, and the various degrees of taurodontism depicted could be interesting dental phenotypic markers of HED forms.

Psychometric properties of the well-being index (WHO-5) spanish version in a sample of euthymic patients with bipolar disorder.

PubMed

Bonnín, C M; Yatham, L N; Michalak, E E; Martínez-Arán, A; Dhanoa, T; Torres, I; Santos-Pascual, C; Valls, E; Carvalho, A F; Sánchez-Moreno, J; Valentí, M; Grande, I; Hidalgo-Mazzei, D; Vieta, E; Reinares, M

2018-03-01

The concept of well-being which focuses on positive emotions has received increased research attention. However, a consensus definition of this term is lacking. The Well-Being Index scale (WHO-5) is a generic, self-report scale that contains five Likert-type items to evaluate psychological well-being. This construct may provide a relevant outcome in bipolar disorder (BD) research and care beyond the rating of mood symptoms. Thus, in the current study, the psychometric properties of the WHO-5 Spanish version were assessed in a sample of euthymic patients with BD. Patients with BD- I and BD-II and healthy controls completed the Well-Being Index (WHO-5) together with an assessment of depressive (Hamilton Depression Rating Scale-17; HAM-D) and manic symptoms (Young Mania Rating Scale; YMRS); and a measure of psychosocial functioning (Functioning Assessment Short Test; FAST). Internal consistency reliability was measured through Cronbach's alpha. Test-retest reliability was calculated comparing the WHO-5 total score at baseline and after 10 days of the first administration. To assess the structure of the scale, a principal component analysis (PCA) was carried out. Correlations between the WHO-5, HAM-D, YMRS and FAST were calculated. Finally, a t-test for independent samples was applied to compare the WHO-5 total score in the patient and control groups. A total of 104 patients with BD and 40 healthy controls were included in this study. A Chronbach's alpha of 0.83 indicated acceptable internal consistency. A paired sample t-test revealed no significant differences between WHO-5 total score at baseline and at follow-up (tn = - 0.72; df = 15; p = 0.48). The PCA provided a single factor solution that accounted for 59.74% of the variation in WHO-5. Test-retest reliability was high (r = 0.83; p < 0.001). Moderate negative correlations were observed between the WHO-5 total score, the FAST (r = - 0.46.; p < 0.001) and the HAM-D (r = - 0.68; p < 0.001), but not with the YMRS (r = - 0.07; p = 0.42). Finally, significant differences were found when comparing the WHO-5 total score between patient and healthy controls (t = 5.1; df = 147; p < 0.001). some limitations include the lack of a comparator scale to test for validity construct and the small sample size in the test-retest reliability CONCLUSIONS: The WHO-5 shows an acceptable reliability index and measures a unitary construct in a Spanish population of euthymic patients with BD. Copyright © 2017 Elsevier B.V. All rights reserved.

SU-F-T-235: Optical Scan Based Collision Avoidance Using Multiple Stereotactic Cameras During Simulation

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

Cardan, R; Popple, R; Dobelbower, M

Purpose: To demonstrate the ability to quickly generate an accurate collision avoidance map using multiple stereotactic cameras during simulation. Methods: Three Kinect stereotactic cameras were placed in the CT simulation room and optically calibrated to the DICOM isocenter. Immediately before scanning, the patient was optically imaged to generate a 3D polygon mesh, which was used to calculate the collision avoidance area using our previously developed framework. The mesh was visually compared to the CT scan body contour to ensure accurate coordinate alignment. To test the accuracy of the collision calculation, the patient and machine were physically maneuvered in the treatmentmore » room to calculated collision boundaries. Results: The optical scan and collision calculation took 38.0 seconds and 2.5 seconds to complete respectively. The collision prediction accuracy was determined using a receiver operating curve (ROC) analysis, where the true positive, true negative, false positive and false negative values were 837, 821, 43, and 79 points respectively. The ROC accuracy was 93.1% over the sampled collision space. Conclusion: We have demonstrated a framework which is fast and accurate for predicting collision avoidance for treatment which can be determined during the normal simulation process. Because of the speed, the system could be used to add a layer of safety with a negligible impact on the normal patient simulation experience. This information could be used during treatment planning to explore the feasible geometries when optimizing plans. Research supported by Varian Medical Systems.« less

Comparative evaluation of PCR amplification of RLEP, 16S rRNA, rpoT and Sod A gene targets for detection of M. leprae DNA from clinical and environmental samples.

PubMed

Turankar, Ravindra P; Pandey, Shradha; Lavania, Mallika; Singh, Itu; Nigam, Astha; Darlong, Joydeepa; Darlong, Fam; Sengupta, Utpal

2015-03-01

PCR assay is a highly sensitive, specific and reliable diagnostic tool for the identification of pathogens in many infectious diseases. Genome sequencing Mycobacterium leprae revealed several gene targets that could be used for the detection of DNA from clinical and environmental samples. The PCR sensitivity of particular gene targets for specific clinical and environmental isolates has not yet been established. The present study was conducted to compare the sensitivity of RLEP, rpoT, Sod A and 16S rRNA gene targets in the detection of M. leprae in slit skin smear (SSS), blood, soil samples of leprosy patients and their surroundings. Leprosy patients were classified into Paucibacillary (PB) and Multibacillary (MB) types. Ziehl-Neelsen (ZN) staining method for all the SSS samples and Bacteriological Index (BI) was calculated for all patients. Standard laboratory protocol was used for DNA extraction from SSS, blood and soil samples. PCR technique was performed for the detection of M. leprae DNA from all the above-mentioned samples. RLEP gene target was able to detect the presence of M. leprae in 83% of SSS, 100% of blood samples and in 36% of soil samples and was noted to be the best out of all other gene targets (rpoT, Sod A and 16S rRNA). It was noted that the RLEP gene target was able to detect the highest number (53%) of BI-negative leprosy patients amongst all the gene targets used in this study. Amongst all the gene targets used in this study, PCR positivity using RLEP gene target was the highest in all the clinical and environmental samples. Further, the RLEP gene target was able to detect 53% of blood samples as positive in BI-negative leprosy cases indicating its future standardization and use for diagnostic purposes. Copyright © 2015 Asian African Society for Mycobacteriology. Published by Elsevier Ltd. All rights reserved.

Variation of calcium, copper and iron levels in serum, bile and stone samples of patients having different types of gallstone: A comparative study.

PubMed

Khan, Mustafa; Kazi, Tasneem Gul; Afridi, Hassan Imran; Sirajuddin; Bilal, Muhammad; Akhtar, Asma; Khan, Sabir; Kadar, Salma

2017-08-01

Epidemiological data among the human population has shown a significantly increased incidence of gallstone (GS) disease worldwide. It was studied that some essential (calcium) and transition elements (iron and copper) in bile play an important role in the development of GS. The estimation of calcium, copper and iron were carried out in the serum, gall bladder bile and different types of GS (cholesterol, mixed and pigmented) of 172 patients, age ranged 20-55years. For comparative purpose age matched referents not suffering from GS diseases were also selected. Biliary concentrations of calcium (Ca), iron (Fe) and copper (Cu) were correlated with their concentrations in serum and different types of GS samples. The ratio of Ca, Fe and Cu in bile with serum was also calculated. Understudy metals were determined by flame atomic absorption spectroscopy after acid decomposition of matrices of selected samples. The Ca concentrations in serum samples were significantly higher in patients with pigmented GS as compared to controls (p<0.005), whereas for patients having cholesterol and mixed GS the concentrations were on the lower side. Biliary Ca concentrations of patients were found to be higher than controls, but difference was significant for pigmented GS patients (p>0.001). The contents of Cu and Fe in serum and bile of all patients (except female cholesterol GS patient have low serum iron concentration) were found to be higher than control, but difference was significant in those patients who have pigmented GS. The concentration of Ca, Fe and Cu in different types GS were found in the order, Pigmented>mixed>cholesterol. The bile/serum ratio for Ca, Cu and Fe was found to be significantly higher in pigmented GS patients. Gall bladder bile was slightly alkaline in patients as compared to referents. The density of bile was found to be higher in patients as compared to the referents. Various functional groups present in different types of GS samples were confirmed by Fourier transform infra-red spectroscopy. The higher density and pH of bile, elevated concentrations of transition elements in all types of biological samples (serum, bile and GS), could be an important factor for the formation of different types of GS. Copyright © 2017 Elsevier B.V. All rights reserved.

Terminal patients in Belgian nursing homes: a cost analysis.

PubMed

Simoens, Steven; Kutten, Betty; Keirse, Emmanuel; Vanden Berghe, Paul; Beguin, Claire; Desmedt, Marianne; Deveugele, Myriam; Léonard, Christian; Paulus, Dominique; Menten, Johan

2013-06-01

Policy makers and health care payers are concerned about the costs of treating terminal patients. This study was done to measure the costs of treating terminal patients during the final month of life in a sample of Belgian nursing homes from the health care payer perspective. Also, this study compares the costs of palliative care with those of usual care. This multicenter, retrospective cohort study enrolled terminal patients from a representative sample of nursing homes. Health care costs included fixed nursing home costs, medical fees, pharmacy charges, other charges, and eventual hospitalization costs. Data sources consisted of accountancy and invoice data. The analysis calculated costs per patient during the final month of life at 2007/2008 prices. Nineteen nursing homes participated in the study, generating a total of 181 patients. Total mean nursing home costs amounted to 3,243 € per patient during the final month of life. Total mean nursing home costs per patient of 3,822 € for patients receiving usual care were higher than costs of 2,456 € for patients receiving palliative care (p = 0.068). Higher costs of usual care were driven by higher hospitalization costs (p < 0.001). This study suggests that palliative care models in nursing homes need to be supported because such care models appear to be less expensive than usual care and because such care models are likely to better reflect the needs of terminal patients.

Optimizing 4-Dimensional Magnetic Resonance Imaging Data Sampling for Respiratory Motion Analysis of Pancreatic Tumors

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

Stemkens, Bjorn, E-mail: b.stemkens@umcutrecht.nl; Tijssen, Rob H.N.; Senneville, Baudouin D. de

2015-03-01

Purpose: To determine the optimum sampling strategy for retrospective reconstruction of 4-dimensional (4D) MR data for nonrigid motion characterization of tumor and organs at risk for radiation therapy purposes. Methods and Materials: For optimization, we compared 2 surrogate signals (external respiratory bellows and internal MRI navigators) and 2 MR sampling strategies (Cartesian and radial) in terms of image quality and robustness. Using the optimized protocol, 6 pancreatic cancer patients were scanned to calculate the 4D motion. Region of interest analysis was performed to characterize the respiratory-induced motion of the tumor and organs at risk simultaneously. Results: The MRI navigator was foundmore » to be a more reliable surrogate for pancreatic motion than the respiratory bellows signal. Radial sampling is most benign for undersampling artifacts and intraview motion. Motion characterization revealed interorgan and interpatient variation, as well as heterogeneity within the tumor. Conclusions: A robust 4D-MRI method, based on clinically available protocols, is presented and successfully applied to characterize the abdominal motion in a small number of pancreatic cancer patients.« less

Rate and predictors of negative effects of psychotherapy in psychiatric and psychosomatic inpatients.

PubMed

Rheker, Julia; Beisel, Sylvia; Kräling, Svenja; Rief, Winfried

2017-08-01

Studies examining the rates of negative effects of psychotherapy are rare and the reported rates differ widely. To be able to calculate adequate benefit-cost ratios in conjunction with different samples and settings, we need a deeper understanding of these effects. We therefore investigated whether different treatment settings would reveal varying rates and kinds of negative effects by recruiting patients from a psychiatric (n=93) and a psychosomatic rehabilitation (n=63) hospital. Negative effects of psychotherapy were assessed with the Inventory for the Assessment of Negative Effects of Psychotherapy post-treatment. To investigate whether patients' pre-treatment expectations have an influence on reported negative effects, patients filled in the Patient Questionnaire on Therapy Expectation and Evaluation prior to treatment begin. Patients from the psychiatric hospital reported an average 1.41 negative effects, with 58.7% reporting at least one negative effect. Those from the psychosomatic hospital reported 0.76 negative effects on average, with 45.2% of patients reporting at least one negative effect. The differences between these samples are significant. The two samples' top three reported types of negative effects are that patients had experienced more downs during or just before the end of the therapy, that patients had difficulty making important decisions without the therapist, and that patients were concerned that colleagues or friends might find out about the therapy. A regression analysis revealed that the clinical setting (psychosomatic rehabilitation hospital vs. psychiatric hospital) and expectations in the form of hope of improvement were significant predictors for negative effects of psychotherapy. Our study highlights the need to examine the negative effects of psychotherapy in different settings and samples to better evaluate the benefit-cost ratios of treatments for different patient groups. It also shows that we need guidelines for assessing and reporting negative effects. Copyright © 2017 Elsevier Ireland Ltd. All rights reserved.

Effectiveness of the Stewart Method in the Evaluation of Blood Gas Parameters.

PubMed

Gezer, Mustafa; Bulucu, Fatih; Ozturk, Kadir; Kilic, Selim; Kaldirim, Umit; Eyi, Yusuf Emrah

2015-03-01

In 1981, Peter A. Stewart published a paper describing his concept for employing Strong Ion Difference. In this study we compared the HCO3 levels and Anion Gap (AG) calculated using the classic method and the Stewart method. Four hundred nine (409) arterial blood gases of 90 patients were collected retrospectively. Some were obtained from the same patients in different times and conditions. All blood samples were evaluated using the same device (ABL 800 Blood Gas Analyzer). HCO3 level and AG were calculated using the Stewart method via the website AcidBase.org. HCO3 levels, AG and strong ion difference (SID) were calculated using the Stewart method, incorporating the parameters of age, serum lactate, glucose, sodium, and pH, etc. According to classic method, the levels of HCO3 and AG were 22.4±7.2 mEq/L and 20.1±4.1 mEq/L respectively. According to Stewart method, the levels of HCO3 and AG were 22.6±7.4 and 19.9±4.5 mEq/L respectively. There was strong correlation between the classic method and the Stewart method for calculating HCO3 and AG. The Stewart method may be more effective in the evaluation of complex metabolic acidosis.

National Trends in Emergency Room Visits of Dialysis Patients for Adverse Drug Reactions.

PubMed

Chan, Lili; Saha, Aparna; Poojary, Priti; Chauhan, Kinsuk; Naik, Nidhi; Coca, Steven; Garimella, Pranav S; Nadkarni, Girish N

2018-06-12

Various medications are cleared by the kidneys, therefore patients with impaired renal function, especially dialysis patients are at risk for adverse drug events (ADEs). There are limited studies on ADEs in maintenance dialysis patients. We utilized a nationally representative database, the Nationwide Emergency Department Sample, from 2008 to 2013, to compare emergency department (ED) visits for dialysis and propensity matched non-dialysis patients. Log binomial regression was used to calculate relative risk of hospital admission and logistic regression to calculate ORs for in-hospital mortality while adjusting for patient and hospital characteristics. While ED visits for ADEs decreased in both groups, they were over 10-fold higher in dialysis patients than non-dialysis patients (65.8-88.5 per 1,000 patients vs. 4.6-5.4 per 1,000 patients respectively, p < 0.001). The top medication category associated with ED visits for ADEs in dialysis patients is agents primarily affecting blood constituents, which has increased. After propensity matching, patient admission was higher in dialysis patients than non-dialysis patients, (88 vs. 76%, p < 0.001). Dialysis was associated with a 3% increase in risk of admission and 3 times the odds of in-hospital mortality (adjusted OR 3, 95% CI 2.7-2.3.3). ED visits for ADEs are substantially higher in dialysis patients than non-dialysis patients. In dialysis patients, ADEs associated with agents primarily affecting blood constituents are on the rise. ED visits for ADEs in dialysis patients have higher inpatient admissions and in-hospital mortality. Further studies are needed to identify and implement measures aimed at reducing ADEs in dialysis patients. © 2018 S. Karger AG, Basel.

Can patient comorbidities be included in clinical performance measures for radiation oncology?

PubMed

Owen, Jean B; Khalid, Najma; Ho, Alex; Kachnic, Lisa A; Komaki, Ritsuko; Tao, May Lin; Currey, Adam; Wilson, J Frank

2014-05-01

Patient comorbidities may affect the applicability of performance measures that are inherent in multidisciplinary cancer treatment guidelines. This article describes the distribution of common comorbid conditions by disease site and by patient and facility characteristics in patients who received radiation therapy as part of treatment for cancer of the breast, cervix, lung, prostate, and stomach, and investigates the association of comorbidities with treatment decisions. Stratified two-stage cluster sampling provided a random sample of radiation oncology facilities. Eligible patients were randomly sampled from each participating facility for each disease site, and data were abstracted from medical records. The Adult Comorbidity Evaluation Index (ACE-27) was used to measure comorbid conditions and their severity. National estimates were calculated using SUDAAN statistical software. Multivariable logistic regression models predicted the dependent variable "treatment changed or contraindicated due to comorbidities." The final model showed that ACE-27 was highly associated with change in treatment for patients with severe or moderate index values compared to those with none or mild (P < .001). Two other covariates, age and medical coverage, had no (age) or little (medical coverage) significant contribution to predicting treatment change in the multivariable model. Disease site was associated with treatment change after adjusting for other covariates in the model. ACE-27 is highly predictive of treatment modifications for patients treated for these cancers who receive radiation as part of their care. A standardized tool identifying patients who should be excluded from clinical performance measures allows more accurate use of these measures. Copyright © 2014 by American Society of Clinical Oncology.

Can Patient Comorbidities Be Included in Clinical Performance Measures for Radiation Oncology?

PubMed Central

Owen, Jean B.; Khalid, Najma; Ho, Alex; Kachnic, Lisa A.; Komaki, Ritsuko; Tao, May Lin; Currey, Adam; Wilson, J. Frank

2014-01-01

Purpose: Patient comorbidities may affect the applicability of performance measures that are inherent in multidisciplinary cancer treatment guidelines. This article describes the distribution of common comorbid conditions by disease site and by patient and facility characteristics in patients who received radiation therapy as part of treatment for cancer of the breast, cervix, lung, prostate, and stomach, and investigates the association of comorbidities with treatment decisions. Materials and Methods: Stratified two-stage cluster sampling provided a random sample of radiation oncology facilities. Eligible patients were randomly sampled from each participating facility for each disease site, and data were abstracted from medical records. The Adult Comorbidity Evaluation Index (ACE-27) was used to measure comorbid conditions and their severity. National estimates were calculated using SUDAAN statistical software. Results: Multivariable logistic regression models predicted the dependent variable “treatment changed or contraindicated due to comorbidities.” The final model showed that ACE-27 was highly associated with change in treatment for patients with severe or moderate index values compared to those with none or mild (P < .001). Two other covariates, age and medical coverage, had no (age) or little (medical coverage) significant contribution to predicting treatment change in the multivariable model. Disease site was associated with treatment change after adjusting for other covariates in the model. Conclusions: ACE-27 is highly predictive of treatment modifications for patients treated for these cancers who receive radiation as part of their care. A standardized tool identifying patients who should be excluded from clinical performance measures allows more accurate use of these measures. PMID:24643573

Acetaldehyde production and microbial colonization in oral squamous cell carcinoma and oral lichenoid disease.

PubMed

Marttila, Emilia; Uittamo, Johanna; Rusanen, Peter; Lindqvist, Christian; Salaspuro, Mikko; Rautemaa, Riina

2013-07-01

The main aim of this prospective study was to explore the ability of the oral microbiome to produce acetaldehyde in ethanol incubation. A total of 90 patients [30 oral squamous cell carcinoma (OSCC); 30 oral lichenoid disease (OLD); 30 healthy controls (CO)] were enrolled in the study. Microbial samples were taken from the mucosa using a filter paper method. The density of microbial colonization was calculated and the spectrum analyzed. Microbial acetaldehyde production was measured by gas chromatography. The majority (68%) of cultures produced carcinogenic levels of acetaldehyde (>100 μM) when incubated with ethanol (22 mM). The mean acetaldehyde production by microbes cultured from smoker samples was significantly higher (213 μM) than from non-smoker samples (141 μM) (P=.0326). The oral microbiota from OSCC, OLD patients and healthy individuals are able to produce carcinogenic levels of acetaldehyde. The present provisional study suggests smoking may increase the production of acetaldehyde. Copyright © 2013 Elsevier Inc. All rights reserved.

Screening for Binge Eating Disorders Using the Patient Health Questionnaire in a Community Sample

PubMed Central

Striegel-Moore, Ruth H.; Perrin, Nancy; DeBar, Lynn; Wilson, G. Terence; Rosselli, Francine; Kraemer, Helena C.

2009-01-01

Objective To examine the operating characteristics of the Patient Health Questionnaire eating disorder module (PHQ-ED) for identifying bulimia nervosa/binge eating disorder (BN/BED) or recurrent binge eating (RBE) in a community sample, and to compare true positive (TP) versus false positive (FP) cases on clinical validators. Method 259 screen positive individuals and a random sample of 89 screen negative cases completed a diagnostic interview. Sensitivity, specificity, and Positive Predictive Value (PPV) were calculated. TP and FP cases were compared using t-tests and Chi-Square tests. Results The PHQ-ED had high sensitivity (100%) and specificity (92%) for detecting BN/BED or RBE, but PPV was low (15% or 19%). TP and FP cases did not differ significantly on frequency of subjective bulimic episodes, objective overeating, restraint, on BMI, and on self-rated health. Conclusions The PHQ-ED is recommended for use in large populations only in conjunction with follow-up questions to rule out cases without objective bulimic episodes. PMID:19424976

Bolus Guide: A Novel Insulin Bolus Dosing Decision Support Tool Based on Selection of Carbohydrate Ranges

PubMed Central

Shapira, Gali; Yodfat, Ofer; HaCohen, Arava; Feigin, Paul; Rubin, Richard

2010-01-01

Background Optimal continuous subcutaneous insulin infusion (CSII) therapy emphasizes the relationship between insulin dose and carbohydrate consumption. One widely used tool (bolus calculator) requires the user to enter discrete carbohydrate values; however, many patients might not estimate carbohydrates accurately. This study assessed carbohydrate estimation accuracy in type 1 diabetes CSII users and compared simulated blood glucose (BG) outcomes using the bolus calculator and the “bolus guide,” an alternative system based on ranges of carbohydrate load. Methods Patients (n = 60) estimated the carbohydrate load of a representative sample of meals of known carbohydrate value. The estimated error distribution [coefficient of variation (CV)] was the basis for a computer simulation (n = 1.6 million observations) of insulin recommendations for the bolus guide and bolus calculator, translated into outcome blood glucose (OBG) ranges (≤60, 61–200, >201 mg/dl). Patients (n = 30) completed questionnaires assessing satisfaction with the bolus guide. Results The CV of typical meals ranged from 27.9% to 44.5%. The percentage of simulated OBG for the calculator and the bolus guide in the <60 mg/dl range were 20.8% and 17.2%, respectively, and 13.8% and 15.8%, respectively, in the >200 mg/dl range. The mean and median scores of all bolus guide satisfaction items and ease of learning and use were 4.17 and 4.2, respectively (of 5.0). Conclusion The bolus guide recommendation based on carbohydrate range selection is substantially similar to the calculator based on carbohydrate point estimation and appears to be highly accepted by type 1 diabetes insulin pump users. PMID:20663453

A Bayesian sequential design with adaptive randomization for 2-sided hypothesis test.

PubMed

Yu, Qingzhao; Zhu, Lin; Zhu, Han

2017-11-01

Bayesian sequential and adaptive randomization designs are gaining popularity in clinical trials thanks to their potentials to reduce the number of required participants and save resources. We propose a Bayesian sequential design with adaptive randomization rates so as to more efficiently attribute newly recruited patients to different treatment arms. In this paper, we consider 2-arm clinical trials. Patients are allocated to the 2 arms with a randomization rate to achieve minimum variance for the test statistic. Algorithms are presented to calculate the optimal randomization rate, critical values, and power for the proposed design. Sensitivity analysis is implemented to check the influence on design by changing the prior distributions. Simulation studies are applied to compare the proposed method and traditional methods in terms of power and actual sample sizes. Simulations show that, when total sample size is fixed, the proposed design can obtain greater power and/or cost smaller actual sample size than the traditional Bayesian sequential design. Finally, we apply the proposed method to a real data set and compare the results with the Bayesian sequential design without adaptive randomization in terms of sample sizes. The proposed method can further reduce required sample size. Copyright © 2017 John Wiley & Sons, Ltd.

10 CFR Appendix to Part 474 - Sample Petroleum-Equivalent Fuel Economy Calculations

Code of Federal Regulations, 2014 CFR

2014-01-01

... 10 Energy 3 2014-01-01 2014-01-01 false Sample Petroleum-Equivalent Fuel Economy Calculations..., DEVELOPMENT, AND DEMONSTRATION PROGRAM; PETROLEUM-EQUIVALENT FUEL ECONOMY CALCULATION Pt. 474, App. Appendix to Part 474—Sample Petroleum-Equivalent Fuel Economy Calculations Example 1: An electric vehicle is...

10 CFR Appendix to Part 474 - Sample Petroleum-Equivalent Fuel Economy Calculations

Code of Federal Regulations, 2012 CFR

2012-01-01

... 10 Energy 3 2012-01-01 2012-01-01 false Sample Petroleum-Equivalent Fuel Economy Calculations..., DEVELOPMENT, AND DEMONSTRATION PROGRAM; PETROLEUM-EQUIVALENT FUEL ECONOMY CALCULATION Pt. 474, App. Appendix to Part 474—Sample Petroleum-Equivalent Fuel Economy Calculations Example 1: An electric vehicle is...

10 CFR Appendix to Part 474 - Sample Petroleum-Equivalent Fuel Economy Calculations

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 3 2011-01-01 2011-01-01 false Sample Petroleum-Equivalent Fuel Economy Calculations..., DEVELOPMENT, AND DEMONSTRATION PROGRAM; PETROLEUM-EQUIVALENT FUEL ECONOMY CALCULATION Pt. 474, App. Appendix to Part 474—Sample Petroleum-Equivalent Fuel Economy Calculations Example 1: An electric vehicle is...

10 CFR Appendix to Part 474 - Sample Petroleum-Equivalent Fuel Economy Calculations

Code of Federal Regulations, 2013 CFR

2013-01-01

... 10 Energy 3 2013-01-01 2013-01-01 false Sample Petroleum-Equivalent Fuel Economy Calculations..., DEVELOPMENT, AND DEMONSTRATION PROGRAM; PETROLEUM-EQUIVALENT FUEL ECONOMY CALCULATION Pt. 474, App. Appendix to Part 474—Sample Petroleum-Equivalent Fuel Economy Calculations Example 1: An electric vehicle is...

Respiratory dead space measurement in the investigation of pulmonary embolism in outpatients with pleuritic chest pain.

PubMed

Hogg, Kerstin; Dawson, Deborah; Tabor, Ted; Tabor, Beverly; Mackway-Jones, Kevin

2005-10-01

Pleuritic chest pain is a common presenting condition in the emergency department. A noninvasive bedside rule out test for pulmonary embolism would aid investigating this patient group. Our study aimed to compare the clinical utility of three methods for calculating respiratory dead space in the diagnosis of pulmonary embolism in outpatients with pleuritic chest pain. Prospective diagnostic study. Large city-center emergency department. Between February 2002 and June 2003, 425 patients presenting to the emergency department with pleuritic chest pain were prospectively recruited. Data collection for respiratory dead space was performed in the emergency department by two researchers. The respiratory dead space fraction was calculated independently using three different methods. All patients underwent an independent reference standard diagnostic algorithm to establish the presence or absence of pulmonary embolism. Those with a low modified Wells clinical probability and a normal quantitative d-dimer finding were discharged home. All others followed a reference standard protocol using Prospective Investigation of Pulmonary Embolism Diagnosis-interpreted ventilation/perfusion scanning, CT pulmonary angiography, and digital subtraction pulmonary angiography. All patients were followed up clinically for 3 months. For the Bohr calculation, the area under the receiver operating characteristic curve was 0.62 (95% confidence interval [CI], 0.51 to 0.73), the Enghoff calculation was 0.66 (95% CI, 0.55 to 0.77), and the capillary sample Enghoff was 0.62 (95% CI, 0.49 to 0.65). The optimum Bohr cutoff value gave 100.0% sensitivity (95% CI, 84.5 to 100%) but a low specificity of 22.7% (95% CI, 18.8 to 27.2%). The optimum cutoff points for Enghoff and capillary Enghoff calculations gave sensitivities of 95.3% (95% CI, 77.3 to 99.2%) and 94.4% (95% CI, 74.2 to 99.0%), respectively, with poor specificity. Respiratory dead space analysis does not perform well as a stand-alone diagnostic test for pulmonary embolism in outpatients presenting with pleuritic chest pain.

[Views of professionals and patients on the introduction of computer science into the consultation].

PubMed

Roig Buscató, C; Erra Yuste, N; Seguer Toirán, A; Belda Díaz, S; Juncosa Font, S

2005-09-15

To compare the views of professionals and patients on the computerisation of consultations. Cross-sectional. Rural health district in the province of Barcelona, with a population of about 15,000. Consecutive sampling of people seen in the health district and the group of health professionals working in it. Two anonymous self-filled questionnaires with closed questions aimed at health professionals and a sample of patients (accuracy, 0.05; confidence, 95%; prevalence, 50%). The mean age of the 407 patients was 48.4 (SD, 17.2), with 63.6% women. 21 questionnaires were filled in by the professionals (91%), 12 by doctors, and 9 by nurses. Their mean age was 43.9 (SD, 7.5), and 71.4% were women. For common questions, 54.3% of patients were keen on seeing the screen, while professionals calculated this figure at 11%. 5.6% of patients thought computerisation had changed the relationship, whereas 31.6% of professionals did. 12.6% of patients thought it had made the visit longer, whereas 38.1% of the professionals thought it had. 10.6% of patients and 47.4% of professionals thought it had led to loss of confidentiality. The introduction of computers into consultations was accepted well. Professionals were more worried than patients about possible loss of confidentiality, and thought that there had been bigger changes in the doctor-patient relationship and that visits had become longer.

Associations between dyadic coping and supportive care needs: findings from a study with hematologic cancer patients and their partners.

PubMed

Weißflog, Gregor; Hönig, Klaus; Gündel, Harald; Lang, Dirk; Niederwieser, Dietger; Döhner, Hartmut; Vogelhuber, Martin; Mehnert, Anja; Ernst, Jochen

2017-05-01

The way couples mutually cope with hematologic cancer is likely to influence their levels of supportive care needs (SCN). Therefore, this study evaluated the levels of dyadic coping (DC) and SCN and the concurrent associations between both variables. Three hundred thirty patients with a hematologic malignancy (63% male) and their partners completed the dyadic coping inventory (DCI) and the supportive care needs survey (SCNS-SF-34-G). The levels of dyadic coping (DC) and supportive care needs (SCN) were compared with representative validation samples. Correlational analyses and actor-partner interdependence models (APIM) were calculated to estimate the association between DC and SCN. Partners' stress communication of cancer patients (as part of DC) was decreased in contrast to that of a non-cancer sample. The perception of partners' delegated DC was higher (both with a moderate effect size of g ≥ |0.50|). SCN of patients and partners were lower in the dimensions health system/information and physical problems/daily living in contrast to those of a cancer patients' validation sample (both with a small effect of g ≥ |0.20|). Higher perceptions of partners' negative DC were associated with higher SCN for both patients and partners. The same was true for patients' own stress communication and SCN, but only for the patients. Sociodemographic and illness-related factors were only partially related with the SCN of patients and partners. In order to diminish SCN of patients and partners, a possible way is to strengthen the quality of the dyadic relation. Due to its associations with elevated SCN, stress communication and negative dyadic coping behaviours may be useful targets for psychosocial interventions.

Head-to-head comparison of B-type natriuretic peptide (BNP) and NT-proBNP in daily clinical practice.

PubMed

Mair, Johannes; Gerda, Falkensammer; Renate, Hiemetzberger; Ulmer, Hanno; Andrea, Griesmacher; Pachinger, Otmar

2008-02-29

B-type natriuretic peptide (BNP; Abbott Diagnostics) and N-terminal proBNP (NT-proBNP, Roche Diagnostics) were compared in consecutive samples of 458 patients (mean age 60 years+/-16 years; 159 female, 299 male) sent for NT-proBNP measurement to investigate influences on both markers. BNP and NT-proBNP showed a close correlation with each other (r=0.89, p<0.0001). Using age- and gender-adjusted upper reference values the inter-rater agreement of both parameters was satisfactory (83%, Cohen's kappa coefficient=0.7). The combination of normal BNP and elevated NT-proBNP was significantly more frequent than vice versa (61 vs. 16 patients), and a calculated glomerular filtration rate<60 ml/min/1.73 m(2) was found in 39% of these patients. Multiple linear regression analysis revealed a significant influence of a reduced ejection fraction (<50%), renal dysfunction (calculated glomerular filtration rate<60 ml/min/1.73 m(2)), anemia, hypertension, age, and gender on both BNP and NT-proBNP. In conclusion, despite a close correlation and a satisfactory agreement between both markers in classification, frequent discrepancies in individual patients demonstrate that both markers are clinically not completely equivalent.

Severity and functional disability of patients with occupational contact dermatitis: validation of the German version of the Occupational Contact Dermatitis Disease Severity Index.

PubMed

Ofenloch, Robert F; Diepgen, Thomas L; Popielnicki, Ana; Weisshaar, Elke; Molin, Sonja; Bauer, Andrea; Mahler, Vera; Elsner, Peter; Schmitt, Jochen; Apfelbacher, Christian

2015-02-01

The Occupational Contact Dermatitis Disease Severity Index (ODDI) was designed in Australia to measure severity and functional disability in patients with occupational contact dermatitis (OCD) of the hands. The ODDI was translated into the German language with a linguistic validation process. The psychometric properties of the German version of the ODDI are still unclear. To report the linguistic validation procedure and to perform a psychometric validation by investigating the validity and reliability of the German ODDI version in a sample of patients with OCD. Data were drawn from the baseline assessment (T0) and first follow-up (T1) of the German chronic hand eczema (CHE) registry (CARPE). Spearman correlations of the ODDI with reference measures were computed to assess validity. Cronbach's alpha was calculated as a measure of internal consistency, and the intraclass correlation coefficient (ICC) was calculated to assess retest reliability. The smallest real difference (SRD) and minimal clinically important difference (MCID) were calculated to assess sensitivity to change. Physician Global Assessment (PGA) was used as an anchor for the MCID. Four hundred and twenty-two patients (54.5% female, mean age 45.1 years) were included for analysis. Cronbach's alpha was found to be 0.73. The ICC was 0.79. Correlations between the ODDI total and the Dermatology Life Quality Index (rho = 0.36), and between PGA (rho = 0.48) and patient-assessed disease severity (rho = 0.40), were of moderate strength. The MCID (1.29) was found to be smaller than the SRD (1.87). The German ODDI version is reliable and valid for the measurement of functional impairment and disease severity in patients suffering from OCD. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Techniques for estimating health care costs with censored data: an overview for the health services researcher

PubMed Central

Wijeysundera, Harindra C; Wang, Xuesong; Tomlinson, George; Ko, Dennis T; Krahn, Murray D

2012-01-01

Objective The aim of this study was to review statistical techniques for estimating the mean population cost using health care cost data that, because of the inability to achieve complete follow-up until death, are right censored. The target audience is health service researchers without an advanced statistical background. Methods Data were sourced from longitudinal heart failure costs from Ontario, Canada, and administrative databases were used for estimating costs. The dataset consisted of 43,888 patients, with follow-up periods ranging from 1 to 1538 days (mean 576 days). The study was designed so that mean health care costs over 1080 days of follow-up were calculated using naïve estimators such as full-sample and uncensored case estimators. Reweighted estimators – specifically, the inverse probability weighted estimator – were calculated, as was phase-based costing. Costs were adjusted to 2008 Canadian dollars using the Bank of Canada consumer price index (http://www.bankofcanada.ca/en/cpi.html). Results Over the restricted follow-up of 1080 days, 32% of patients were censored. The full-sample estimator was found to underestimate mean cost ($30,420) compared with the reweighted estimators ($36,490). The phase-based costing estimate of $37,237 was similar to that of the simple reweighted estimator. Conclusion The authors recommend against the use of full-sample or uncensored case estimators when censored data are present. In the presence of heavy censoring, phase-based costing is an attractive alternative approach. PMID:22719214

Applications of Hadamard transform-gas chromatography/mass spectrometry to the detection of acetone in healthy human and diabetes mellitus patient breath.

PubMed

Fan, Gang-Ting; Yang, Chien-Lin; Lin, Cheng-Huang; Chen, Chien-Chung; Shih, Chung-Hung

2014-03-01

The Hadamard transform-gas chromatography/mass spectrometry (HT-GC/MS) technique was successfully employed to detect acetone, a biomarker for diabetes mellitus (DM) prediction, in human breath. Samples of exhaled breath were collected from four DM patients (one type-I and three type-II) and eight volunteers (nondiabetic healthy subjects), respectively. The gas samples, without any pretreatment, were simultaneously injected into a GC column through a Hadamard-injector based on Hadamard codes. Under optimized conditions, when cyclic S-matrix orders of 255, 1023 and 2047 were used, the S/N ratios of the acetone signals were substantially improved by 8.0-, 16.0- and 22.6-fold, respectively; these improvements are in good agreement with theoretically calculated values. We found that the breath acetone concentration levels in the four DM patients and the eight volunteers ranged from 1 to 10 ppmv and 0.1 to 1 ppmv, respectively. Copyright © 2014 Elsevier B.V. All rights reserved.

40 CFR 89.424 - Dilute emission sampling calculations.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 20 2010-07-01 2010-07-01 false Dilute emission sampling calculations... Emission Test Procedures § 89.424 Dilute emission sampling calculations. (a) The final reported emission... concentration. For cases where exhaust sampling of CO2 is not performed, the following approximation is...

40 CFR 89.424 - Dilute emission sampling calculations.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 20 2011-07-01 2011-07-01 false Dilute emission sampling calculations... Emission Test Procedures § 89.424 Dilute emission sampling calculations. (a) The final reported emission... concentration. For cases where exhaust sampling of CO2 is not performed, the following approximation is...

Biased visualization of hypoperfused tissue by computed tomography due to short imaging duration: improved classification by image down-sampling and vascular models.

PubMed

Mikkelsen, Irene Klærke; Jones, P Simon; Ribe, Lars Riisgaard; Alawneh, Josef; Puig, Josep; Bekke, Susanne Lise; Tietze, Anna; Gillard, Jonathan H; Warburton, Elisabeth A; Pedraza, Salva; Baron, Jean-Claude; Østergaard, Leif; Mouridsen, Kim

2015-07-01

Lesion detection in acute stroke by computed-tomography perfusion (CTP) can be affected by incomplete bolus coverage in veins and hypoperfused tissue, so-called bolus truncation (BT), and low contrast-to-noise ratio (CNR). We examined the BT-frequency and hypothesized that image down-sampling and a vascular model (VM) for perfusion calculation would improve normo- and hypoperfused tissue classification. CTP datasets from 40 acute stroke patients were retrospectively analysed for BT. In 16 patients with hypoperfused tissue but no BT, repeated 2-by-2 image down-sampling and uniform filtering was performed, comparing CNR to perfusion-MRI levels and tissue classification to that of unprocessed data. By simulating reduced scan duration, the minimum scan-duration at which estimated lesion volumes came within 10% of their true volume was compared for VM and state-of-the-art algorithms. BT in veins and hypoperfused tissue was observed in 9/40 (22.5%) and 17/40 patients (42.5%), respectively. Down-sampling to 128 × 128 resolution yielded CNR comparable to MR data and improved tissue classification (p = 0.0069). VM reduced minimum scan duration, providing reliable maps of cerebral blood flow and mean transit time: 5 s (p = 0.03) and 7 s (p < 0.0001), respectively). BT is not uncommon in stroke CTP with 40-s scan duration. Applying image down-sampling and VM improve tissue classification. • Too-short imaging duration is common in clinical acute stroke CTP imaging. • The consequence is impaired identification of hypoperfused tissue in acute stroke patients. • The vascular model is less sensitive than current algorithms to imaging duration. • Noise reduction by image down-sampling improves identification of hypoperfused tissue by CTP.

Recommendations and administration of the HPV vaccine to 11- to 12-year-old girls and boys: a statewide survey of Georgia vaccines for children provider practices.

PubMed

Luque, John S; Tarasenko, Yelena N; Dixon, Betty T; Vogel, Robert L; Tedders, Stuart H

2014-10-01

This study explores the prevalence and provider- and practice-related correlates of physician recommendation and administration of the quadrivalent human papillomavirus (HPV) vaccine, Gardasil, to 11- to 12-year-old girls and the intention to recommend the HPV vaccine to 11- to 12-year-old boys in Georgia. The study also describes physician knowledge about and barriers to HPV vaccination. This cross-sectional study was conducted from December 2010 to February 2011. The study sample was drawn using the Georgia Vaccines for Children (VFC) provider list as a sampling frame and probability 1-stage cluster sampling with counties as clusters. The final analytic sample was restricted to 206 provider locations. Weighted percentages and corresponding statistics were calculated accounting for selection probabilities, nonresponse, and the cluster sample design. Among Georgia VFC providers attending to 11- to 12-year-old girls, 46% had always recommended that their patients get the HPV vaccination and 41% had vaccinated their female patients. Among Georgia VFC providers attending to 11- to 12-year-old boys, 20% would always recommend that their male patients get vaccinated.Physicians most frequently endorsed costs of stocking the vaccine (73%), upfront costs (69%), vaccination (68%), and insurance reimbursements (63%) as barriers to their HPV vaccination practices. Despite the Advisory Committee on Immunization Practices' recommendations on HPV vaccination, the prevalence of recommending and administering the HPV vaccine to female and male patients, aged 11 to 12 years, by VFC providers is an ongoing challenge in Georgia.

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

PubMed

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

2012-05-01

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

Phadiatop Seropositivity in Schizophrenia Patients and Controls: A Preliminary Study

PubMed Central

Okusaga, Olaoluwa; Hamilton, Robert G.; Can, Adem; Igbide, Ajirioghene; Giegling, Ina; Hartmann, Annette M.; Konte, Bettina; Friedl, Marion; Reeves, Gloria M; Rujescu, Dan; Postolache, Teodor T.

2014-01-01

There is a dearth of information on the association of atopy with schizophrenia. The few available studies used population-based registers to classify the atopy status of the patients but this strategy is not reliable. This study measured seropositivity with a multiallergen screen of allergen specific IgE antibodies in schizophrenia patients versus healthy controls. A subset of 66 schizophrenia patients and 34 healthy controls were randomly selected from a large comparative study of schizophrenia patients and controls. The Phadiatop multi-allergen screen was performed on sera from all the participants to assess their atopic status. Logistic regression was used to calculate the odds ratio for the association of schizophrenia with Phadiatop seropositivity as a measure of atopy. The prevalence of Phadiatop seropositivity was significantly lower (χ2 4.59, p = 0.032) and there was a reduced odds ratio for atopy in schizophrenia patients relative to controls (OR 0.40; 95% CI 0.17 to 0.94, p = 0.036). Though limited by a relatively small sample size and potentially confounded by anti-psychotic medications, this study suggests that the prevalence of atopy is lower in patients with schizophrenia. Replicating these results in larger samples could add to our growing understanding of immunological implications in mental illness. PMID:25346942

[Detection of antibodies against Legionella pneumophila from pleural effusion--a case report of Legionnaire's pneumonia with pleural effusion].

PubMed

Xu, L; Wang, P; Chen, S

1994-06-01

Using TAT and ELISA, 50 samples of pleural effusion and sera from patients infected with non-Legionella pneumophila were detected for antibodies against Legionella pneumophila serogroups 1 and 6, respectively. The average titre and upper limit value (99%, mean + 2.326S) calculated. In addition, a pleural effusion and a serum from a patient with Legionnaire's pneumonia were also detected by TAT and ELISA. The result showed that the titre of this antibody in his pleural effusion was not only over the upper limit, but also higher than that in his serum.

Influence of drugs of abuse and alcohol upon patients admitted to acute psychiatric wards: physician's assessment compared to blood drug concentrations.

PubMed

Mordal, Jon; Medhus, Sigrid; Holm, Bjørn; Mørland, Jørg; Bramness, Jørgen G

2013-06-01

In acute psychiatric services, rapid and accurate detection of psychoactive substance intake may be required for appropriate diagnosis and intervention. The aim of this study was to investigate the relationship between (a) drug influence as assessed by physicians and (b) blood drug concentrations among patients admitted to acute psychiatric wards. We also explored the possible effects of age, sex, and psychotic symptoms on physician's assessment of drug influence. In a cross-sectional study, the sample comprised 271 consecutive admissions from 2 acute psychiatric wards. At admission, the physician on call performed an overall judgment of drug influence. Psychotic symptoms were assessed with the positive subscale of the Positive and Negative Syndrome Scale. Blood samples were screened for a wide range of psychoactive substances, and quantitative results were used to calculate blood drug concentration scores. Patients were judged as being under the influence of drugs and/or alcohol in 28% of the 271 admissions. Psychoactive substances were detected in 56% of the blood samples. Altogether, 15 different substances were found; up to 8 substances were found in samples from 1 patient. Markedly elevated blood drug concentration scores were estimated for 15% of the patients. Physician's assessment was positively related to the blood drug concentration scores (r = 0.52; P < 0.001), to symptoms of excitement, and to the detection of alcohol, cannabis, and amphetamines. The study demonstrates the major impact of alcohol and drugs in acute psychiatric settings and illustrates the challenging nature of the initial clinical assessment.

Assessing sensitivity to change: choosing the appropriate change coefficient.

PubMed

Stratford, Paul W; Riddle, Daniel L

2005-04-05

The past 20-years have seen the development and evaluation of many health status measures. Unlike the high standards demanded of those who conduct and report clinical intervention trials, the methodological rigor for studies examining the sensitivity to change of health status measures are less demanding. It is likely that the absence of a criterion standard for change in health status contributes to this shortcoming. To increase confidence in the results of these types of studies investigators have often calculated multiple change coefficients for the same patient sample. The purpose of this report is to identify the conflict that arises when multiple change coefficients are applied to the same patient sample. Three families of change coefficients based on different assumptions concerning the sample composition are identified: (1) the sample is homogeneous with respect to change; (2) subgroups of patients who truly change by different amounts exist; (3) individual patients, many of whom truly change by different amounts exist. We present several analyses which illustrate a major conceptual conflict: the signal (a measure's true ability to detect change) for some of these coefficients appears in the noise term (measurement error) of the others. We speculate that this dilemma occurs as a result of insufficient preparatory work such as pilot studies to establish the likely change characteristic of the patient population of interest. Uncertainty in the choice of change coefficient could be overcome by conducting pilot studies to ascertain the likely change characteristic of the population of interest. Once the population's change characteristic is identified, the choice of change coefficient should be clear.

[The cost of polypharmacy in patients with type 2 diabetes mellitus].

PubMed

García A, Luz María; Villarreal R, Enrique; Galicia R, Liliana; Martínez G, Lidia; Vargas D, Emma Rosa

2015-05-01

Polypharmacy or the concomitant use of three or more medications, may increase the complexity of health care and its costs. To determine the costs of polypharmacy in patients with Type 2 Diabetes Mellitus in a Mexican population sample. Analysis of health care costs in 257 patients with Type 2 Diabetes Mellitus from two family care facilities, who had at least five consultations during one year. The cost of professional care by family physicians, pharmacological care and medications were considered to calculate the total expenses. The price of medications and the number of units consumed in one year were used to determine pharmacological expenses. Medications were grouped to determine costs derived from complications and concomitant diseases. Costs were calculated in US dollars (USD). The mean cost derived from family physician fees was USD 82.32 and from pharmacy fees USD 29.37. The mean cost of medications for diabetes treatment was USD 33.31, for the management of complications USD 13.9 and for management of concomitant diseases USD 23.7, rendering a total cost of USD 70.92. Thus, the total annual care cost of a diabetic patient was USD 182.61. Medications represent less than 50% of total expenses of diabetic patients with polypharmacy.

Validity of hearing impairment calculation methods for prediction of self-reported hearing handicap.

PubMed

John, Andrew B; Kreisman, Brian M; Pallett, Stephen

2012-01-01

Worker's compensation for hearing loss caused by occupational noise exposure is calculated by varying methods, from state to state within the United States (US), with many employing arithmetic formulas based on the pure-tone audiogram, to quantify hearing loss. Several assumptions unsupported or weakly supported by empirical data underlie these formulas. The present study evaluated the ability of various arithmetic hearing impairment calculations to predict a self-reported hearing handicap in a sample of presenting with sensorineural hearing loss. 204 adults (127 male, 77 female) ranging in age from 18 to 94 served as participants. The sample was selected to exclude patients who had been referred for hearing testing for a medicolegal examination or a hearing conservation appointment. A hearing handicap was measured by the Hearing Handicap Inventory for Adults/for the Elderly (HHIA/E). The covariance analysis of linear structural equations was used to assess the relative strength of correlation with the HHIA/E score among the six formulas and various forms of pure-tone average. The results revealed that all the hearing impairment calculations examined were significantly, but weakly, correlated with the self-reported hearing impairment scores. No significant differences among the predictive abilities of the impairment calculations were evident; however, the average binaural impairment assigned differed significantly among the six calculations examined. Individuals who demonstrated 0% impairment had significantly lower (i.e., better) HHIA/E scores compared to those with non-zero impairment for each formula. These results supported the idea that audiometric data provided an insufficient explanation for real-world hearing difficulties.

The Clinical and Economic Burden of Hyperkalemia on Medicare and Commercial Payers.

PubMed

Fitch, Kathryn; Woolley, J Michael; Engel, Tyler; Blumen, Helen

2017-06-01

Hyperkalemia (serum potassium >5.0 mEq/L) may be caused by reduced kidney function and drugs affecting the renin-angiotensin-aldosterone system and is often present in patients with chronic kidney disease (CKD). To quantify the burden of hyperkalemia in US Medicare fee-for-service and commercially insured populations using real-world claims data, focusing on prevalence, comorbidities, mortality, medical utilization, and cost. A descriptive, retrospective claims data analysis was performed on patients with hyperkalemia using the 2014 Medicare 5% sample and the 2014 Truven Health Analytics MarketScan Commercial Claims and Encounter databases. The starting study samples required patient insurance eligibility during ≥1 months in 2014. The identification of hyperkalemia and other comorbidities required having ≥1 qualifying claims in 2014 with an appropriate International Classification of Diseases, Ninth Revision, Clinical Modification diagnosis code in any position. To address the differences between patients with and without hyperkalemia, CKD subsamples were analyzed separately. Mortality rates were calculated in the Medicare sample population only. The claims were grouped into major service categories; the allowed costs reflected all costs incurred by each cohort divided by the total number of member months for that cohort. The prevalence of hyperkalemia in the Medicare and commercially insured samples was 2.3% and 0.09%, respectively. Hyperkalemia was associated with multiple comorbidities, most notably CKD. The prevalence of CKD in the Medicare and the commercially insured members with hyperkalemia was 64.8% and 31.8%, respectively. After adjusting for CKD severity, the annual mortality rate for Medicare patients with CKD and hyperkalemia was 24.9% versus 10.4% in patients with CKD without hyperkalemia. The allowed costs in patients with CKD and hyperkalemia in the Medicare and commercially insured cohorts were more than twice those in patients with CKD without hyperkalemia. Inpatient care accounted for >50% of costs in patients with CKD and hyperkalemia. Hyperkalemia is associated with substantial clinical and economic burden among US commercially insured and Medicare populations.

Circulating miR-132-3p as a Candidate Diagnostic Biomarker for Malignant Mesothelioma

PubMed Central

Gawrych, Katarzyna; Casjens, Swaantje; Brik, Alexander; Lehnert, Martin; Taeger, Dirk; Pesch, Beate; Kollmeier, Jens; Bauer, Torsten T.; Johnen, Georg; Brüning, Thomas

2017-01-01

The use of circulating microRNAs as biomarkers has opened new opportunities for diagnosis of cancer because microRNAs exhibit tumor-specific expression profiles. The aim of this study was the identification of circulating microRNAs in human plasma as potential biomarkers for the diagnosis of malignant mesothelioma. For discovery, TaqMan Low Density Array Human MicroRNA Cards were used to analyze 377 microRNAs in plasma samples from 21 mesothelioma patients and 21 asbestos-exposed controls. For verification, individual TaqMan microRNA assays were used for quantitative real-time PCR in plasma samples from 22 mesothelioma patients and 44 asbestos-exposed controls. The circulating miR-132-3p showed different expression levels between mesothelioma patients and asbestos-exposed controls. For discrimination, sensitivity of 86% and specificity of 61% were calculated. Circulating miR-132-3p in plasma was not affected by hemolysis and no impact of age or smoking status on miR-132-3p levels could be observed. For the combination of miR-132-3p with the previously described miR-126, sensitivity of 77% and specificity of 86% were calculated. The results of this study indicate that miR-132-3p might be a new promising diagnostic biomarker for malignant mesothelioma. It is indicated that the combination of miR-132-3p with other individual biomarkers improves the biomarker performance. PMID:28321148

Characteristics of randomised trials on diseases in the digestive system registered in ClinicalTrials.gov: a retrospective analysis.

PubMed

Wildt, Signe; Krag, Aleksander; Gluud, Liselotte

2011-01-01

Objectives To evaluate the adequacy of reporting of protocols for randomised trials on diseases of the digestive system registered in http://ClinicalTrials.gov and the consistency between primary outcomes, secondary outcomes and sample size specified in http://ClinicalTrials.gov and published trials. Methods Randomised phase III trials on adult patients with gastrointestinal diseases registered before January 2009 in http://ClinicalTrials.gov were eligible for inclusion. From http://ClinicalTrials.gov all data elements in the database required by the International Committee of Medical Journal Editors (ICMJE) member journals were extracted. The subsequent publications for registered trials were identified. For published trials, data concerning publication date, primary and secondary endpoint, sample size, and whether the journal adhered to ICMJE principles were extracted. Differences between primary and secondary outcomes, sample size and sample size calculations data in http://ClinicalTrials.gov and in the published paper were registered. Results 105 trials were evaluated. 66 trials (63%) were published. 30% of trials were registered incorrectly after their completion date. Several data elements of the required ICMJE data list were not filled in, with missing data in 22% and 11%, respectively, of cases concerning the primary outcome measure and sample size. In 26% of the published papers, data on sample size calculations were missing and discrepancies between sample size reporting in http://ClinicalTrials.gov and published trials existed. Conclusion The quality of registration of randomised controlled trials still needs improvement.

Violent patients: what Italian psychiatrists feel and how this could change their patient care.

PubMed

Catanesi, Roberto; Carabellese, Felice; Candelli, Chiara; Valerio, Antonia; Martinelli, Domenico

2010-06-01

The study takes a detailed look at psychiatric patient violence towards their psychiatrists. It takes into consideration the views and opinions of Italian psychiatrists, whether they have experienced violent behaviour first hand and, if so, which type of aggression and whether this caused them to modify their behaviour towards the patient and his or her treatment. A multiple-choice questionnaire is sent to all members of the Italian Society of Psychiatry, with 1,202 psychiatrists responding (20.23% of the sample). The data are evaluated using SPSS with chi-square test calculations for discrete and continuous variables and t-testing for independent samples (significance p < .05). Almost all psychiatrists (90.9%) have experienced verbal aggression; 72% have been threatened with dangerous objects and 64.58% have suffered physical aggression. Physical aggression experiences result in a 50% increase in the probability of modifying one's therapeutic behaviour. Significant differences emerge between the psychiatrists, according to differences in age and career experience. Psychiatrists state that they do not consider themselves to be adequately prepared to deal with the violence of patients, and almost all psychiatrists felt the need for specific training in how to manage such violence.

Do we treat our patients or rather periodontal microbes with adjunctive antibiotics in periodontal therapy? A 16S rDNA microbial community analysis.

PubMed

Hagenfeld, Daniel; Koch, Raphael; Jünemann, Sebastian; Prior, Karola; Harks, Inga; Eickholz, Peter; Hoffmann, Thomas; Kim, Ti-Sun; Kocher, Thomas; Meyle, Jörg; Kaner, Doğan; Schlagenhauf, Ulrich; Ehmke, Benjamin; Harmsen, Dag

2018-01-01

Empiric antibiotics are often used in combination with mechanical debridement to treat patients suffering from periodontitis and to eliminate disease-associated pathogens. Until now, only a few next generation sequencing 16S rDNA amplicon based publications with rather small sample sizes studied the effect of those interventions on the subgingival microbiome. Therefore, we studied subgingival samples of 89 patients with chronic periodontitis (solely non-smokers) before and two months after therapy. Forty-seven patients received mechanical periodontal therapy only, whereas 42 patients additionally received oral administered amoxicillin plus metronidazole (500 and 400 mg, respectively; 3x/day for 7 days). Samples were sequenced with Illumina MiSeq 300 base pairs paired end technology (V3 and V4 hypervariable regions of the 16S rDNA). Inter-group differences before and after therapy of clinical variables (percentage of sites with pocket depth ≥ 5mm, percentage of sites with bleeding on probing) and microbiome variables (diversity, richness, evenness, and dissimilarity) were calculated, a principal coordinate analysis (PCoA) was conducted, and differential abundance of agglomerated ribosomal sequence variants (aRSVs) classified on genus level was calculated using a negative binomial regression model. We found statistically noticeable decreased richness, and increased dissimilarity in the antibiotic, but not in the placebo group after therapy. The PCoA revealed a clear compositional separation of microbiomes after therapy in the antibiotic group, which could not be seen in the group receiving mechanical therapy only. This difference was even more pronounced on aRSV level. Here, adjunctive antibiotics were able to induce a microbiome shift by statistically noticeably reducing aRSVs belonging to genera containing disease-associated species, e.g., Porphyromonas, Tannerella, Treponema, and Aggregatibacter, and by noticeably increasing genera containing health-associated species. Mechanical therapy alone did not statistically noticeably affect any disease-associated taxa. Despite the difference in microbiome modulation both therapies improved the tested clinical parameters after two months. These results cast doubt on the relevance of the elimination and/or reduction of disease-associated taxa as a main goal of periodontal therapy.

Application of flexible endoscopy-based biopsy in the diagnosis of tumour pathologies in otorhinolaryngology.

PubMed

Saga, Carlos; Olalde, Manuel; Larruskain, Ekhiñe; Álvarez, Leire; Altuna, Xabier

Interventional endoscopy allows us to act on the pathology of the patient with minimal discomfort, low costs and high efficiency. We assessed the validity of flexible endoscopic biopsies in our hospital, in lesions suspected of malignancy in the rhino-pharyngo-laryngeal space. Retrospective study of patients with a pathology suspected of malignancy assessed between 2006-2016 in our centre. We evaluated the effectiveness, the tolerance and the number of complications. We calculated the cost reduction in comparison with direct laryngoscopy in the operating room. We compared our sample with others of similar characteristics described in the literature. Thirty patients were studied with a flexible endoscopic biopsy during that period. Nineteen patients obtained positive results which allowed them to start treatment for their pathology. Seven cases had no evidence of malignancy and required another biopsy under general anaesthesia, which confirmed the carcinoma diagnosis. Two samples ruled out malignancy which was confirmed by laryngeal microsurgery. One case showed inflammation and the lesion was cured after antibiotherapy. It was impossible to collect the sample in one case. Thus, we obtained sensitivity levels of 73% with a specificity of 100%. There were no complications. The cost reduction in our sample was above 80%. Flexible endoscopic biopsy has advantages over direct laryngoscopy that are relevant in the diagnosis of oncological pathology in otorhinolaryngology. Copyright © 2017 Elsevier España, S.L.U. and Sociedad Española de Otorrinolaringología y Cirugía de Cabeza y Cuello. All rights reserved.

Dose calculation with respiration-averaged CT processed from cine CT without a respiratory surrogate

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

Riegel, Adam C.; Ahmad, Moiz; Sun Xiaojun

2008-12-15

Dose calculation for thoracic radiotherapy is commonly performed on a free-breathing helical CT despite artifacts caused by respiratory motion. Four-dimensional computed tomography (4D-CT) is one method to incorporate motion information into the treatment planning process. Some centers now use the respiration-averaged CT (RACT), the pixel-by-pixel average of the ten phases of 4D-CT, for dose calculation. This method, while sparing the tedious task of 4D dose calculation, still requires 4D-CT technology. The authors have recently developed a means to reconstruct RACT directly from unsorted cine CT data from which 4D-CT is formed, bypassing the need for a respiratory surrogate. Using RACTmore » from cine CT for dose calculation may be a means to incorporate motion information into dose calculation without performing 4D-CT. The purpose of this study was to determine if RACT from cine CT can be substituted for RACT from 4D-CT for the purposes of dose calculation, and if increasing the cine duration can decrease differences between the dose distributions. Cine CT data and corresponding 4D-CT simulations for 23 patients with at least two breathing cycles per cine duration were retrieved. RACT was generated four ways: First from ten phases of 4D-CT, second, from 1 breathing cycle of images, third, from 1.5 breathing cycles of images, and fourth, from 2 breathing cycles of images. The clinical treatment plan was transferred to each RACT and dose was recalculated. Dose planes were exported at orthogonal planes through the isocenter (coronal, sagittal, and transverse orientations). The resulting dose distributions were compared using the gamma ({gamma}) index within the planning target volume (PTV). Failure criteria were set to 2%/1 mm. A follow-up study with 50 additional lung cancer patients was performed to increase sample size. The same dose recalculation and analysis was performed. In the primary patient group, 22 of 23 patients had 100% of points within the PTV pass {gamma} criteria. The average maximum and mean {gamma} indices were very low (well below 1), indicating good agreement between dose distributions. Increasing the cine duration generally increased the dose agreement. In the follow-up study, 49 of 50 patients had 100% of points within the PTV pass the {gamma} criteria. The average maximum and mean {gamma} indices were again well below 1, indicating good agreement. Dose calculation on RACT from cine CT is negligibly different from dose calculation on RACT from 4D-CT. Differences can be decreased further by increasing the cine duration of the cine CT scan.« less

An analytic linear accelerator source model for GPU-based Monte Carlo dose calculations.

PubMed

Tian, Zhen; Li, Yongbao; Folkerts, Michael; Shi, Feng; Jiang, Steve B; Jia, Xun

2015-10-21

Recently, there has been a lot of research interest in developing fast Monte Carlo (MC) dose calculation methods on graphics processing unit (GPU) platforms. A good linear accelerator (linac) source model is critical for both accuracy and efficiency considerations. In principle, an analytical source model should be more preferred for GPU-based MC dose engines than a phase-space file-based model, in that data loading and CPU-GPU data transfer can be avoided. In this paper, we presented an analytical field-independent source model specifically developed for GPU-based MC dose calculations, associated with a GPU-friendly sampling scheme. A key concept called phase-space-ring (PSR) was proposed. Each PSR contained a group of particles that were of the same type, close in energy and reside in a narrow ring on the phase-space plane located just above the upper jaws. The model parameterized the probability densities of particle location, direction and energy for each primary photon PSR, scattered photon PSR and electron PSR. Models of one 2D Gaussian distribution or multiple Gaussian components were employed to represent the particle direction distributions of these PSRs. A method was developed to analyze a reference phase-space file and derive corresponding model parameters. To efficiently use our model in MC dose calculations on GPU, we proposed a GPU-friendly sampling strategy, which ensured that the particles sampled and transported simultaneously are of the same type and close in energy to alleviate GPU thread divergences. To test the accuracy of our model, dose distributions of a set of open fields in a water phantom were calculated using our source model and compared to those calculated using the reference phase-space files. For the high dose gradient regions, the average distance-to-agreement (DTA) was within 1 mm and the maximum DTA within 2 mm. For relatively low dose gradient regions, the root-mean-square (RMS) dose difference was within 1.1% and the maximum dose difference within 1.7%. The maximum relative difference of output factors was within 0.5%. Over 98.5% passing rate was achieved in 3D gamma-index tests with 2%/2 mm criteria in both an IMRT prostate patient case and a head-and-neck case. These results demonstrated the efficacy of our model in terms of accurately representing a reference phase-space file. We have also tested the efficiency gain of our source model over our previously developed phase-space-let file source model. The overall efficiency of dose calculation was found to be improved by ~1.3-2.2 times in water and patient cases using our analytical model.

The quality of the reported sample size calculations in randomized controlled trials indexed in PubMed.

PubMed

Lee, Paul H; Tse, Andy C Y

2017-05-01

There are limited data on the quality of reporting of information essential for replication of the calculation as well as the accuracy of the sample size calculation. We examine the current quality of reporting of the sample size calculation in randomized controlled trials (RCTs) published in PubMed and to examine the variation in reporting across study design, study characteristics, and journal impact factor. We also reviewed the targeted sample size reported in trial registries. We reviewed and analyzed all RCTs published in December 2014 with journals indexed in PubMed. The 2014 Impact Factors for the journals were used as proxies for their quality. Of the 451 analyzed papers, 58.1% reported an a priori sample size calculation. Nearly all papers provided the level of significance (97.7%) and desired power (96.6%), and most of the papers reported the minimum clinically important effect size (73.3%). The median (inter-quartile range) of the percentage difference of the reported and calculated sample size calculation was 0.0% (IQR -4.6%;3.0%). The accuracy of the reported sample size was better for studies published in journals that endorsed the CONSORT statement and journals with an impact factor. A total of 98 papers had provided targeted sample size on trial registries and about two-third of these papers (n=62) reported sample size calculation, but only 25 (40.3%) had no discrepancy with the reported number in the trial registries. The reporting of the sample size calculation in RCTs published in PubMed-indexed journals and trial registries were poor. The CONSORT statement should be more widely endorsed. Copyright © 2016 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved.

Is there a correlation between physicians' clinical impressions and patients' perceptions of change? Use of the Perceived Change Scale with inpatients with mental disorders.

PubMed

Pavan, Gabriela; Godoy, Julia Almeida; Monteiro, Ricardo Tavares; Moreschi, Hugo Karling; Nogueira, Eduardo Lopes; Spanemberg, Lucas

2016-01-01

Assessment of the results of treatment for mental disorders becomes more complete when the patient's perspective is incorporated. Here, we aimed to evaluate the psychometric properties and application of the Perceived Change Scale - Patient version (PCS-P) in a sample of inpatients with mental disorders. One hundred and ninety-one psychiatric inpatients answered the PCS-P and the Patients' Satisfaction with Mental Health Services Scale (SATIS) and were evaluated in terms of clinical and sociodemographic data. An exploratory factor analysis (EFA) was performed and internal consistency was calculated. The clinical impressions of the patient, family, and physician were correlated with the patient's perception of change. The EFA indicated a psychometrically suitable four-factor solution. The PCS-P exhibited a coherent relationship with SATIS and had a Cronbach's alpha value of 0.856. No correlations were found between the physician's clinical global impression of improvement and the patient's perception of change, although a moderate positive correlation was found between the patients' clinical global impression of improvement and the change perceived by the patient. The PCS-P exhibited adequate psychometric proprieties in a sample of inpatients with mental disorders. The patient's perception of change is an important dimension for evaluation of outcomes in the treatment of mental disorders and differs from the physician's clinical impression of improvement. Evaluation of positive and negative perceptions of the various dimensions of the patient's life enables more precise consideration of the patient's priorities and interests.

Regional metabolic liver function measured in patients with cirrhosis by 2-[¹⁸F]fluoro-2-deoxy-D-galactose PET/CT.

PubMed

Sørensen, Michael; Mikkelsen, Kasper S; Frisch, Kim; Villadsen, Gerda E; Keiding, Susanne

2013-06-01

There is a clinical need for methods that can quantify regional hepatic function non-invasively in patients with cirrhosis. Here we validate the use of 2-[(18)F]fluoro-2-deoxy-d-galactose (FDGal) PET/CT for measuring regional metabolic function to this purpose, and apply the method to test the hypothesis of increased intrahepatic metabolic heterogeneity in cirrhosis. Nine cirrhotic patients underwent dynamic liver FDGal PET/CT with blood samples from a radial artery and a liver vein. Hepatic blood flow was measured by indocyanine green infusion/Fick's principle. From blood measurements, hepatic systemic clearance (Ksyst, Lblood/min) and hepatic intrinsic clearance (Vmax/Km, Lblood/min) of FDGal were calculated. From PET data, hepatic systemic clearance of FDGal in liver parenchyma (Kmet, mL blood/mL liver tissue/min) was calculated. Intrahepatic metabolic heterogeneity was evaluated in terms of coefficient-of-variation (CoV, %) using parametric images of Kmet. Mean approximation of Ksyst to Vmax/Km was 86% which validates the use of FDGal as PET tracer of hepatic metabolic function. Mean Kmet was 0.157 mL blood/mL liver tissue/min, which was lower than 0.274 mL blood/mL liver tissue/min, previously found in healthy subjects (p<0.001), in accordance with decreased metabolic function in cirrhotic livers. Mean CoV for Kmet in liver tissue was 24.4% in patients and 14.4% in healthy subjects (p<0.0001). The degree of intrahepatic metabolic heterogeneity correlated positively with HVPG (p<0.05). A 20-min dynamic FDGal PET/CT with arterial sampling provides an accurate measure of regional hepatic metabolic function in patients with cirrhosis. This is likely to have clinical implications for the assessment of patients with liver disease as well as treatment planning and monitoring. Copyright © 2013 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.

Cardiorespiratory dynamics measured from continuous ECG monitoring improves detection of deterioration in acute care patients: A retrospective cohort study.

PubMed

Moss, Travis J; Clark, Matthew T; Calland, James Forrest; Enfield, Kyle B; Voss, John D; Lake, Douglas E; Moorman, J Randall

2017-01-01

Charted vital signs and laboratory results represent intermittent samples of a patient's dynamic physiologic state and have been used to calculate early warning scores to identify patients at risk of clinical deterioration. We hypothesized that the addition of cardiorespiratory dynamics measured from continuous electrocardiography (ECG) monitoring to intermittently sampled data improves the predictive validity of models trained to detect clinical deterioration prior to intensive care unit (ICU) transfer or unanticipated death. We analyzed 63 patient-years of ECG data from 8,105 acute care patient admissions at a tertiary care academic medical center. We developed models to predict deterioration resulting in ICU transfer or unanticipated death within the next 24 hours using either vital signs, laboratory results, or cardiorespiratory dynamics from continuous ECG monitoring and also evaluated models using all available data sources. We calculated the predictive validity (C-statistic), the net reclassification improvement, and the probability of achieving the difference in likelihood ratio χ2 for the additional degrees of freedom. The primary outcome occurred 755 times in 586 admissions (7%). We analyzed 395 clinical deteriorations with continuous ECG data in the 24 hours prior to an event. Using only continuous ECG measures resulted in a C-statistic of 0.65, similar to models using only laboratory results and vital signs (0.63 and 0.69 respectively). Addition of continuous ECG measures to models using conventional measurements improved the C-statistic by 0.01 and 0.07; a model integrating all data sources had a C-statistic of 0.73 with categorical net reclassification improvement of 0.09 for a change of 1 decile in risk. The difference in likelihood ratio χ2 between integrated models with and without cardiorespiratory dynamics was 2158 (p value: <0.001). Cardiorespiratory dynamics from continuous ECG monitoring detect clinical deterioration in acute care patients and improve performance of conventional models that use only laboratory results and vital signs.

SU-F-J-23: Field-Of-View Expansion in Cone-Beam CT Reconstruction by Use of Prior Information

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

Haga, A; Magome, T; Nakano, M

Purpose: Cone-beam CT (CBCT) has become an integral part of online patient setup in an image-guided radiation therapy (IGRT). In addition, the utility of CBCT for dose calculation has actively been investigated. However, the limited size of field-of-view (FOV) and resulted CBCT image with a lack of peripheral area of patient body prevents the reliability of dose calculation. In this study, we aim to develop an FOV expanded CBCT in IGRT system to allow the dose calculation. Methods: Three lung cancer patients were selected in this study. We collected the cone-beam projection images in the CBCT-based IGRT system (X-ray volumemore » imaging unit, ELEKTA), where FOV size of the provided CBCT with these projections was 410 × 410 mm{sup 2} (normal FOV). Using these projections, CBCT with a size of 728 × 728 mm{sup 2} was reconstructed by a posteriori estimation algorithm including a prior image constrained compressed sensing (PICCS). The treatment planning CT was used as a prior image. To assess the effectiveness of FOV expansion, a dose calculation was performed on the expanded CBCT image with region-of-interest (ROI) density mapping method, and it was compared with that of treatment planning CT as well as that of CBCT reconstructed by filtered back projection (FBP) algorithm. Results: A posteriori estimation algorithm with PICCS clearly visualized an area outside normal FOV, whereas the FBP algorithm yielded severe streak artifacts outside normal FOV due to under-sampling. The dose calculation result using the expanded CBCT agreed with that using treatment planning CT very well; a maximum dose difference was 1.3% for gross tumor volumes. Conclusion: With a posteriori estimation algorithm, FOV in CBCT can be expanded. Dose comparison results suggested that the use of expanded CBCTs is acceptable for dose calculation in adaptive radiation therapy. This study has been supported by KAKENHI (15K08691).« less

Spectrophotometric photodynamic detection involving extracorporeal treatment with hexaminolevulinate for bladder cancer cells in voided urine.

PubMed

Nakai, Yasushi; Ozawa, Toshiyuki; Mizuno, Fumiko; Onishi, Sayuri; Owari, Takuya; Hori, Syunta; Morizawa, Yosuke; Tatsumi, Yosihiro; Miyake, Makito; Tanaka, Nobumichi; Tsuruta, Daisuke; Fujimoto, Kiyohide

2017-11-01

To evaluate the feasibility of hexaminolevulinate (HAL) for the photodynamic detection of cancer cells in voided urine. This study included 50 patients with bladder cancer that was confirmed histologically after transurethral resection (bladder cancer group) and 50 outpatients without a history of urothelial carcinoma or cancer-related findings (no malignancy group). One third of the voided urine samples were incubated with aminolevulinic acid (ALA-treated samples), one third were incubated with HAL (HAL-treated samples), and the remaining samples were incubated without treatment (untreated samples). For detecting cellular protoporphyrin IX levels, the intensity of the samples at the excitation wavelength of 405 nm was measured using a spectrophotometer. The difference between the intensity of the ALA-treated or HAL-treated samples and the untreated samples at 635 nm was calculated. HAL-induced fluorescence cytology (HFC) showed that the difference was significantly higher in patients with high-grade tumors than in those with low-grade tumors (p = 0.0003) and the difference was significantly higher in patients with low-grade tumors than in those without a history of urothelial carcinoma or cancer-related findings (p = 0.021). The areas under the receiver operating characteristic curves of ALA-induced fluorescence cytology (AFC) and HFC were 0.77 and 0.81, respectively. The AUC of HFC was significantly higher than that of AFC (p < 0.0001). The overall sensitivity values for conventional cytology, AFC, and HFC were 49, 74, and 74%, respectively. The overall specificity values for AFC and HFC were 70 and 94%, respectively. Spectrophotometric photodynamic detection involving extracorporeal treatment with HAL for bladder cancer cells in voided urine showed high accuracy. This bladder cancer detection method is easy and cost-effective, and has the potential for clinical use.

The Power of Low Back Pain Trials: A Systematic Review of Power, Sample Size, and Reporting of Sample Size Calculations Over Time, in Trials Published Between 1980 and 2012.

PubMed

Froud, Robert; Rajendran, Dévan; Patel, Shilpa; Bright, Philip; Bjørkli, Tom; Eldridge, Sandra; Buchbinder, Rachelle; Underwood, Martin

2017-06-01

A systematic review of nonspecific low back pain trials published between 1980 and 2012. To explore what proportion of trials have been powered to detect different bands of effect size; whether there is evidence that sample size in low back pain trials has been increasing; what proportion of trial reports include a sample size calculation; and whether likelihood of reporting sample size calculations has increased. Clinical trials should have a sample size sufficient to detect a minimally important difference for a given power and type I error rate. An underpowered trial is one within which probability of type II error is too high. Meta-analyses do not mitigate underpowered trials. Reviewers independently abstracted data on sample size at point of analysis, whether a sample size calculation was reported, and year of publication. Descriptive analyses were used to explore ability to detect effect sizes, and regression analyses to explore the relationship between sample size, or reporting sample size calculations, and time. We included 383 trials. One-third were powered to detect a standardized mean difference of less than 0.5, and 5% were powered to detect less than 0.3. The average sample size was 153 people, which increased only slightly (∼4 people/yr) from 1980 to 2000, and declined slightly (∼4.5 people/yr) from 2005 to 2011 (P < 0.00005). Sample size calculations were reported in 41% of trials. The odds of reporting a sample size calculation (compared to not reporting one) increased until 2005 and then declined (Equation is included in full-text article.). Sample sizes in back pain trials and the reporting of sample size calculations may need to be increased. It may be justifiable to power a trial to detect only large effects in the case of novel interventions. 3.

Evaluation of individual quality of life among hemodialysis patients: nominated themes using SEIQoL-adapted.

PubMed

Matlabi, Hossein; Ahmadzadeh, Sharareh

2017-01-01

Quality of life (QoL) has become an important issue for patients with chronic renal failure diseases who are permanently undergoing hemodialysis. In this study, an adapted schedule for the evaluation of individual quality of life (SEIQoL-adapted) was used to evaluate QoL among hemodialysis patients, to explore their views about the most important aspects of life satisfaction. A multiple approach design and convenience sampling were applied to recruit 53 patients from a hemodialysis unit in Iran. Data were collected through structured interviews and then analyzed using conventional content analysis. A total score for QoL was calculated using scale guideline. The most important aspects of life were health, family, financial status, living conditions, leisure activities, relationships and socializing, religious and spiritual issues, medical knowledge, and therapies or treatments. The calculated mean QoL score was 66.2, indicating a relatively high life satisfaction. Males had higher QoL scores than females in both married and single groups. Moreover, the relationships between the QoL scores and education, job and marital status were not statistically significant. The SEIQoL-adapted revealed reasonable lay definitions of QoL in a group of patients following chronic renal failure. The patients' views of the aspects of life could be used by health policy makers, clinicians, and caregivers as a reliable guide to the most important priorities for treatment and medical interventions.

Pre-Analytical Components of Risk in Four Branches of Clinical Laboratory in Romania--Prospective Study.

PubMed

David, Remona E; Dobreanu, Minodora

2016-01-01

Development of quality measurement principles is a strategic point for each clinical laboratory. Preexamination process is the most critical and the most difficult to be managed. The aim of this study is to identify, quantify, and monitor the nonconformities of the pre-analytical process using quality indicators that can affect the patient's health safety in four different locations of a Romanian private clinical laboratory. The study group consisted of all the analysis requests received by the departments of biochemistry, hematology, and coagulation from January through March 2015. In order to collect the pre-analytical nonconformities, we created a "Risk Budget", using the entries from the "Evidence notebook--non-conform samples" from the above mentioned departments. The laboratory established the quality indicators by means of the risk management technique in order to identify and control the sources of errors, FMEA (Failure Modes and Effects Analyses), which had been implemented and monitored for its purposes and special needs. For the assessment of the control level over the processes, the results were transformed on the Six Sigma scale, using the Westgard calculation method and being obtained in this way the frequency with which an error may occur. (https://www.westgard. com/six-sigma-calculators.htm). The obtained results prove that the quantification and monitoring of the indicators can be a control instrument for the pre-analytic activities. The calculation of the Six Sigma value adds extra information to the study because it allows the detection of the processes which need improvement (Sigma value higher than 4 represents a well controlled process). The highest rates were observed for the hemolyzed and the lipemic samples, in the department of biochemistry and hemolyzed, insufficient sample volume, or clotted samples for the department of hematology and coagulation. Significant statistical differences between laboratories participating in the study have been recorded for these indicators. The elaborated study between the four branches of a Romanian private clinical laboratory was a challenge, and it helped in choosing strategic decisions regarding the improvement of the patient's health safety in the institution, corresponding to the accreditation requirements in accordance with ISO 15189:2013.

Air and smear sample calculational tool for Fluor Hanford Radiological control

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

BAUMANN, B.L.

2003-07-11

A spreadsheet calculation tool was developed to automate the calculations performed for determining the concentration of airborne radioactivity and smear counting as outlined in HNF-13536, Section 5.2.7, ''Analyzing Air and Smear Samples''. This document reports on the design and testing of the calculation tool. Radiological Control Technicians (RCTs) will save time and reduce hand written and calculation errors by using an electronic form for documenting and calculating work place air samples. Current expectations are RCTs will perform an air sample and collect the filter or perform a smear for surface contamination. RCTs will then survey the filter for gross alphamore » and beta/gamma radioactivity and with the gross counts utilize either hand calculation method or a calculator to determine activity on the filter. The electronic form will allow the RCT with a few key strokes to document the individual's name, payroll, gross counts, instrument identifiers; produce an error free record. This productivity gain is realized by the enhanced ability to perform mathematical calculations electronically (reducing errors) and at the same time, documenting the air sample.« less

Correlation between Serum Uric Acid Level and Microalbuminuria in Type-2 Diabetic Nephropathy

PubMed Central

Latif, Hina; Iqbal, Adil; Rathore, Rabia; Butt, Nasir Farooq

2017-01-01

Objective: To measure the correlation between microalbuminuria and serum uric acid level in Type-2 diabetic nephropathy. Methods: This cross-sectional study was done in department of Medicine, Mayo hospital Lahore from August 2014 to February 2015. A total of 200 patients with Type-2 diabetic nephropathy were enrolled in the study. Demographic data and contact details were obtained. Serum Uric acid and microalbuminuria by albumin to creatinine ratio (ACR) in random urine sample was measured at the time of inclusion of patients. All the information was collected through a pre-defined proforma. Pearson correlation coefficient and t-test were used to assess correlation and significance respectively. Results: Out of 200 cases, 29%(n=58) were between 16-40 years of age while 71%(n=142) were between 41-65 years of age, Mean ± SD was calculated as 48.1±10.26 years, 48.5%(n=97) were male and 51.5%(n=103) were females, Mean serum uric acid level was calculated as 6.99±1.01 mg/dL while microalbuminuria was calculated as 5.63±1.08 mg/mmol, r value was 0.0838 which is a positive correlation. Conclusion: The results of our study concluded that level of serum uric acid and microalbuminuria are significantly correlated to nephropathy in patients having Type-2 diabetes mellitus. PMID:29492061

ENHANCEMENT OF LEARNING ON SAMPLE SIZE CALCULATION WITH A SMARTPHONE APPLICATION: A CLUSTER-RANDOMIZED CONTROLLED TRIAL.

PubMed

Ngamjarus, Chetta; Chongsuvivatwong, Virasakdi; McNeil, Edward; Holling, Heinz

2017-01-01

Sample size determination usually is taught based on theory and is difficult to understand. Using a smartphone application to teach sample size calculation ought to be more attractive to students than using lectures only. This study compared levels of understanding of sample size calculations for research studies between participants attending a lecture only versus lecture combined with using a smartphone application to calculate sample sizes, to explore factors affecting level of post-test score after training sample size calculation, and to investigate participants’ attitude toward a sample size application. A cluster-randomized controlled trial involving a number of health institutes in Thailand was carried out from October 2014 to March 2015. A total of 673 professional participants were enrolled and randomly allocated to one of two groups, namely, 341 participants in 10 workshops to control group and 332 participants in 9 workshops to intervention group. Lectures on sample size calculation were given in the control group, while lectures using a smartphone application were supplied to the test group. Participants in the intervention group had better learning of sample size calculation (2.7 points out of maximnum 10 points, 95% CI: 24 - 2.9) than the participants in the control group (1.6 points, 95% CI: 1.4 - 1.8). Participants doing research projects had a higher post-test score than those who did not have a plan to conduct research projects (0.9 point, 95% CI: 0.5 - 1.4). The majority of the participants had a positive attitude towards the use of smartphone application for learning sample size calculation.

Small intestinal malabsorption in chronic alcoholism: a retrospective study of alcoholic patients by the ¹⁴C-D-xylose breath test.

PubMed

Hope, Håvar; Skar, Viggo; Sandstad, Olav; Husebye, Einar; Medhus, Asle W

2012-04-01

The ¹⁴C-D-xylose breath test was used at Ullevål University Hospital in the period from 1986 TO 1995 for malabsorption testing. The objective of this retrospective study was to reveal whether patients with chronic alcoholism may have intestinal malabsorption. The consecutive ¹⁴C-D-xylose breath test database was reviewed and patients with the diagnosis of chronic alcoholism were identified. ¹⁴C-D-xylose breath test results of the alcoholic patients were compared with the results of untreated celiac patients and patient and healthy controls. In the ¹⁴C-D-xylose breath test, ¹⁴C-D-xylose was dissolved in water and given orally after overnight fast. Breath samples were taken at 30-min intervals for 210 min, and ¹⁴CO₂ : ¹²CO₂ ratios were calculated for each time point, presenting a time curve for ¹⁴C-D-xylose absorption. Urine was collected after 210 min and the fraction of the total d-xylose passed was calculated (U%). ¹⁴CO₂ in breath and ¹⁴C-D-xylose in urine were analyzed using liquid scintillation. Both breath and urine analysis revealed a pattern of malabsorption in alcoholics comparable with untreated celiac patients, with significantly reduced absorption of d-xylose compared with patient and healthy controls. Alcoholic patients have a significantly reduced ¹⁴C-D-xylose absorption, comparable with untreated celiac patients. This indicates a reduced intestinal function in chronic alcoholism.

Clinical utility of pH paper versus pH meter in the measurement of critical gastric pH in stress ulcer prophylaxis.

PubMed

Bradley, J S; Phillips, J O; Cavanaugh, J E; Metzler, M H

1998-11-01

To evaluate the clinical utility of measuring gastric pH with a pH meter vs. pH paper in critical care patients. Prospective comparison of gastric pH measurements, using both pH meter and pH paper. Surgical intensive care unit (ICU) at a rural Midwestern university medical center. Fifty-one patients who received therapy for prophylaxis of stress ulcers in the surgical ICU. Therapy for stress ulcer prophylaxis was monitored. The pH of 985 gastric samples, taken from 51 patients, was measured with both pH meter and pH paper. The pH meter and pH paper measures demonstrated a concordance correlation coefficient of .896. The mean difference between the two measures (pH paper - pH meter) was estimated to be between -0.4 and 1.4, suggesting a positive bias for the paper. The prevalence of events representing clinically relevant differences between the pH meter and pH paper in the measurement of the same gastric sample was calculated. The frequency with which each of the events occurred consecutively (or, in one case, two nearly consecutive events on the same day) was also calculated. Bias in a clinically relevant range was estimated. A set of "probability profiles" was constructed. A hand-held pH meter and pH paper are not interchangeable measures of gastric pH. The pH paper exhibits an appreciable positive bias compared with a hand-held pH meter in the clinically relevant range of 2 to 6. More research is needed to determine if that bias affects treatment outcomes. We recommend the use of a pH meter for patients who demonstrate pH readings of < or = 4, consecutive with readings of < or = 5.

Detection of epidermal growth factor receptor gene T790M mutation in cytology samples using the cobas® EGFR mutation test.

PubMed

Satouchi, Miyako; Tanaka, Hiroshi; Yoshioka, Hiroshige; Shimokawaji, Tadasuke; Mizuno, Keiko; Takeda, Koji; Yoshino, Ichiro; Seto, Takashi; Kurata, Takayasu; Tashiro, Naoki; Hagiwara, Koichi

2017-09-01

Detection of epidermal growth factor receptor (EGFR) gene mutations is essential in deciding therapeutic strategy in non-small cell lung cancer (NSCLC) patients at initial diagnosis. Moreover, in EGFR mutation-positive (EGFRm) NSCLC patients, re-biopsy at disease progression to clarify resistance mechanisms is also important. However, collecting histology samples is often difficult because of inaccessibility and invasiveness. In some cases, only cytology samples can be collected, and studies have reported that cytology samples are appropriate for EGFR gene mutation testing. The cobas ® EGFR Mutation Test (Roche Molecular Systems Inc., Branchburg, New Jersey, USA) is approved as a companion diagnostic for osimertinib, a third-generation EGFR-tyrosine kinase inhibitor approved in Japan. However, it is not clear whether the EGFR T790M mutation can be detected in cytology samples using this test. The primary objective of this study was to assess concordance of EGFR T790M gene mutation detection between histology and matched cytology samples using the cobas ® EGFR Mutation Test. We conducted a multicenter, observational study in Japan. Overall, 41 EGFRm NSCLC patients who had both histology and cytology samples collected at the same time at re-biopsy and with the results of EGFR mutation test using histology samples were enrolled. The EGFR mutation status of both sample types was tested using the cobas ® EGFR Mutation Test and the concordance rates were calculated. The EGFR T790M mutation detection rate in histology and cytology samples was 42.5% and 37.5%, respectively. The overall percent agreement between the histology and cytology samples was 91.7%. These data demonstrate that the cobas ® EGFR Mutation Test can detect the EGFR T790M mutation in both cytology and histology samples. Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved.

The influence of procedure delay on resource use: a national study of patients with open tibial fracture.

PubMed

Sears, Erika Davis; Burke, James F; Davis, Matthew M; Chung, Kevin C

2013-03-01

The purpose of this study was to (1) understand national variation in delay of emergency procedures in patients with open tibial fracture at the hospital level and (2) compare length of stay and cost in patients cared for at the best- and worst-performing hospitals for delay. The authors retrospectively analyzed the 2003 to 2009 Nationwide Inpatient Sample. Adult patients with open tibial fracture were included. Hospital probability of delay in performing emergency procedures beyond the day of admission was calculated. Multilevel linear regression random-effects models were created to evaluate the relationship between the treating hospital's tendency for delay (in quartiles) and the log-transformed outcomes of length of stay and cost. The final sample included 7029 patients from 332 hospitals. Patients treated at hospitals in the fourth (worst) quartile for delay were estimated to have 12 percent (95 percent CI, 2 to 21 percent) higher cost compared with patients treated at hospitals in the first quartile. In addition, patients treated at hospitals in the fourth quartile had an estimated 11 percent (95 percent CI, 4 to 17 percent) longer length of stay compared with patients treated at hospitals in the first quartile. Patients with open tibial fracture treated at hospitals with more timely initiation of surgical care had lower cost and shorter length of stay than patients treated at hospitals with less timely initiation of care. Policies directed toward mitigating variation in care may reduce unnecessary waste.

Quantitative optical frequency domain imaging assessment of in-stent structures in patients with ST-segment elevation myocardial infarction: impact of imaging sampling rate.

PubMed

Muramatsu, Takashi; García-García, Hector M; Lee, Il Soo; Bruining, Nico; Onuma, Yoshinobu; Serruys, Patrick W

2012-01-01

The impact of the sampling rate (SR) of optical frequency domain imaging (OFDI) on quantitative assessment of in-stent structures (ISS) such as plaque prolapse and thrombus remains unexplored. OFDI after stenting was performed in ST-segment elevation myocardial infarction (STEMI) patients using a TERUMO OFDI system (Terumo Europe, Leuven, Belgium) with 160 frames/s and pullback speed of 20 mm/s. A total of 126 stented segments were analyzed. ISS were classified as either attached or non-attached to stent area boundaries. The volume, mean area and largest area of ISS were assessed according to 4 frequencies of SR, corresponding to distances between the analyzed frames of 0.125, 0.25, 0.50 and 1.0 mm. ISS volume was calculated by integrating cross-sectional ISS areas multiplied by each sampling distance using the disk summation method. The volume and mean area of ISS became significantly larger, while the largest area became significantly smaller as sampling distance became larger (1.11 mm(2) for 0.125 mm vs. 1.00 mm(2) for 1.0 mm, P for trend=0.036). In addition, variance of difference was positively associated with increasing width of sampling distance. Quantification of ISS is significantly influenced by the applied frequency of SR. This should be taken into account when designing future OFDI studies in which quantitative assessment of ISS is critical for the evaluation of STEMI patients.

Depressive Symptoms in Patients Referred to a Tertiary Lyme Center: High Prevalence in Those Without Evidence of Lyme Borreliosis.

PubMed

Zomer, Tizza P; Vermeeren, Yolande M; Landman, Gijs W; Zwerink, Marlies; van Hees, Babette C; van Bemmel, Thomas; van Kooten, Barend

2017-10-30

Controversy exists whether mood disorders, such as depression, are associated with Lyme borreliosis (LB). The study objective was to assess prevalence of depressive symptoms in subgroups of patients referred to a tertiary Lyme center, to investigate whether depressive symptoms can be used in clinical practice to discriminate for LB. This cohort study included adult patients who visited a tertiary Lyme center between January 2008 and December 2014. Prior to medical consultation, serum samples were taken and the Beck Depression Inventory II was completed to assess depressive symptoms. Lyme diagnosis was retrospectively extracted from the patient's medical record. Patients were classified based on clinical LB and serology results. Prevalence of moderate/severe depressive symptoms was calculated. Using logistic regression, odds ratios with 95% confidence intervals (CIs) were calculated for moderate/severe depressive symptoms. In total, 1454 patients were included. Prevalence of moderate/severe depressive symptoms was lowest in patients with no clinical LB and positive serology (15.3%), higher in patients with clinical LB with positive and negative serology (19.3% and 20.9% respectively), and highest in patients with no clinical LB and negative serology (29.3%). The odds ratio for moderate/severe depressive symptoms in patients with LB and positive serology was 0.71 (95% CI, .50-1.03) compared to patients with no LB and negative serology. The prevalence of depressive symptoms was similar in patients with LB compared to patients with no evidence of infection. This suggests that depressive symptoms cannot be used to discriminate for LB in a tertiary Lyme center. © The Author 2017. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.

Risk of Retinal Artery Occlusion in Patients With End-Stage Renal Disease

PubMed Central

Chang, Yuh-Shin; Weng, Shih-Feng; Chang, Chun; Wang, Jhi-Joung; Tseng, Sung-Huei; Ko, Shun-Yao; Su, Shih-Bin; Huang, Chien-Cheng; Wang, Jiu-Yao; Jan, Ren-Long

2016-01-01

Abstract There is globally increasing prevalence and incidence in end-stage renal disease (ESRD). These patients are frequently reported to have retinal abnormalities and both diseases share some systemic risk factors. Hence, it is clinically relevant to determine whether ESRD is a predictor of retinal artery occlusion (RAO). To investigate the risk of RAO in ESRD patients. A retrospective, nationwide, matched cohort study. The study included 93,766 ESRD patients recruited between 2000 and 2009 from the Taiwan National Health Insurance Research Database. The same number control group included age- and sex-matched patients without ESRD selected from the Taiwan Longitudinal Health Insurance Database, 2000. Data for each patient were collected from the index date until December 2011. The incidence and risk of RAO were compared between the 2 groups. The hazard ratio (HR) for RAO after adjustment for potential confounders was calculated using Cox proportional hazards regression. Kaplan–Meier analysis was used to calculate the cumulative RAO incidence rate. In total, 237 ESRD patients and 73 controls exhibited RAO during follow-up; thus, the RAO incidence rate in ESRD patients was 4.49 times (95% confidence interval (CI), 3.45–5.83) that in the control patients. After adjustment for potential confounders, including diabetes mellitus, hypertension, hyperlipidemia, congestive heart failure, and coronary artery disease, ESRD patients were 2.78 times (95% CI, 2.02–3.84) more likely to develop RAO in cohort for the total sample. Among patients with hypertension, the RAO incidence rate was significantly higher in the ESRD group, and hypertension significantly increased RAO risk even after adjustment for other confounders in the cohort. ESRD increases the risk of RAO, particularly in ESRD patients with hypertension. Therefore, clinicians should educate ESRD patients about RAO and ensure appropriate blood pressure control. PMID:27057891

Risk of Retinal Artery Occlusion in Patients With End-Stage Renal Disease: A Retrospective Large-Scale Cohort Study.

PubMed

Chang, Yuh-Shin; Weng, Shih-Feng; Chang, Chun; Wang, Jhi-Joung; Tseng, Sung-Huei; Ko, Shun-Yao; Su, Shih-Bin; Huang, Chien-Cheng; Wang, Jiu-Yao; Jan, Ren-Long

2016-04-01

There is globally increasing prevalence and incidence in end-stage renal disease (ESRD). These patients are frequently reported to have retinal abnormalities and both diseases share some systemic risk factors. Hence, it is clinically relevant to determine whether ESRD is a predictor of retinal artery occlusion (RAO).To investigate the risk of RAO in ESRD patients.A retrospective, nationwide, matched cohort study. The study included 93,766 ESRD patients recruited between 2000 and 2009 from the Taiwan National Health Insurance Research Database. The same number control group included age- and sex-matched patients without ESRD selected from the Taiwan Longitudinal Health Insurance Database, 2000. Data for each patient were collected from the index date until December 2011.The incidence and risk of RAO were compared between the 2 groups. The hazard ratio (HR) for RAO after adjustment for potential confounders was calculated using Cox proportional hazards regression. Kaplan-Meier analysis was used to calculate the cumulative RAO incidence rate.In total, 237 ESRD patients and 73 controls exhibited RAO during follow-up; thus, the RAO incidence rate in ESRD patients was 4.49 times (95% confidence interval (CI), 3.45-5.83) that in the control patients. After adjustment for potential confounders, including diabetes mellitus, hypertension, hyperlipidemia, congestive heart failure, and coronary artery disease, ESRD patients were 2.78 times (95% CI, 2.02-3.84) more likely to develop RAO in cohort for the total sample. Among patients with hypertension, the RAO incidence rate was significantly higher in the ESRD group, and hypertension significantly increased RAO risk even after adjustment for other confounders in the cohort.ESRD increases the risk of RAO, particularly in ESRD patients with hypertension. Therefore, clinicians should educate ESRD patients about RAO and ensure appropriate blood pressure control.

In-hospital fall-risk screening in 4,735 geriatric patients from the LUCAS project.

PubMed

Neumann, L; Hoffmann, V S; Golgert, S; Hasford, J; Von Renteln-Kruse, W

2013-03-01

In-hospital falls in older patients are frequent, but the identification of patients at risk of falling is challenging. Aim of this study was to improve the identification of high-risk patients. Therefore, a simplified screening-tool was developed, validated, and compared to the STRATIFY predictive accuracy. Retrospective analysis of 4,735 patients; evaluation of predictive accuracy of STRATIFY and its single risk factors, as well as age, gender and psychotropic medication; splitting the dataset into a learning and a validation sample for modelling fall-risk screening and independent, temporal validation. Geriatric clinic at an academic teaching hospital in Hamburg, Germany. 4,735 hospitalised patients ≥65 years. Sensitivity, specificity, positive and negative predictive value, Odds Ratios, Youden-Index and the rates of falls and fallers were calculated. There were 10.7% fallers, and the fall rate was 7.9/1,000 hospital days. In the learning sample, mental alteration (OR 2.9), fall history (OR 2.1), and insecure mobility (Barthel-Index items 'transfer' + 'walking' score = 5, 10 or 15) (OR 2.3) had the most strongest association to falls. The LUCAS Fall-Risk Screening uses these risk factors, and patients with ≥2 risk factors contributed to the high-risk group (30.9%). In the validation sample, STRATIFY SENS was 56.8, SPEC 59.6, PPV 13.5 and NPV 92.6 vs. LUCAS Fall-Risk Screening was SENS 46.0, SPEC 71.1, PPV 14.9 and NPV 92.3. Both the STRATIFY and the LUCAS Fall-Risk Screening showed comparable results in defining a high-risk group. Impaired mobility and cognitive status were closely associated to falls. The results do underscore the importance of functional status as essential fall-risk factor in older hospitalised patients.

Nitric oxide levels in patients with diabetes mellitus: A systematic review and meta-analysis.

PubMed

Assmann, Taís S; Brondani, Letícia A; Bouças, Ana P; Rheinheimer, Jakeline; de Souza, Bianca M; Canani, Luís H; Bauer, Andrea C; Crispim, Daisy

2016-12-30

Altered serum nitric oxide (NO) levels in patients with diabetes mellitus (DM) have been reported by different studies; however, results are still controversial. Until this date, no meta-analysis evaluated the association of NO levels with DM. Thus, this paper describes a meta-analysis conducted to evaluate if there is a relationship between NO levels and type 1 DM (T1DM) or type 2 DM (T2DM). A literature search was done to identify all studies that investigated NO levels between T1DM or T2DM patients (cases) and non-diabetic subjects (controls). Measurement of nitrate and nitrite (NOx - the stable NO products) were used to estimate NO concentrations because they closely reflect NO bioavailability. Weighted mean differences (WMD) of NOx levels between case and control samples were calculated for T1DM and T2DM groups. Thirty studies were eligible for inclusion in the meta-analysis (8 in T1DM samples and 22 in T2DM samples). NOx levels were increased in European T1DM patients compared with controls [random effect model (REM) WMD = 8.55, 95% CI 2.88 - 14.21]. No other ethnicity was evaluated in T1DM studies. NOx levels were also increased in both European (REM WMD = 18.76, 95% CI 1.67 - 35.85) and Asian (REM WMD = 18.41, 95% CI 8.01 - 28.81) T2DM patients, but not in Latin American patients compared with controls. This meta-analysis detected a significant increase in NOx levels in European T1DM patients as well as European and Asian T2DM patients. Further studies in other ethnicities are necessary to confirm these data. Copyright © 2016 Elsevier Inc. All rights reserved.

Chromosomal Aberrations and Survival after Unrelated Donor Hematopoietic Stem Cell Transplant in Patients with Fanconi Anemia.

PubMed

Wang, Youjin; Zhou, Weiyin; Alter, Blanche P; Wang, Tao; Spellman, Stephen R; Haagenson, Michael; Yeager, Meredith; Lee, Stephanie J; Chanock, Stephen J; Savage, Sharon A; Gadalla, Shahinaz M

2018-06-04

Studies of chromosomal aberrations in blood or bone marrow of patients with Fanconi anemia (FA) have focused on their associations with leukemic transformation. The role of such abnormalities on outcomes after hematopoietic cell transplantation (HCT) is unclear. We used genome-wide single nucleotide polymorphism arrays to identify chromosomal aberrations in pre-HCT blood samples from 73 patients with FA who received unrelated donor HCT for severe aplastic anemia between 1991 and 2007. Outcome data and blood samples were available through the Center for International Blood and Marrow Transplant Research. For survival analyses, we used the Kaplan-Meier estimator to calculate the survival probabilities and the exact log-rank test to compare the survival differences across groups. Chromosomal aberrations were detected in 16 (22%) patients; most frequent were clonal copy loss in chromosome 7 (9.6%), clonal copy gains in the long arm (q) of chromosome 1 (chr1q + ) (8.2%), and clonal or complete copy gains in the q arm of chromosome 3 (chr3q + ) (8.2%). Seven (9.6%) patients had alterations in 3 or more chromosomes. Poor post-HCT overall survival (OS) was noted in patients with chr3q +  (P = .04), or those with abnormalities in ≥3 chromosomes (P = .03). The 1-year OS was 0% versus 45% in patients with either alteration versus its absence. No statistically significant differences in 1-year OS were noted in patients carrying deletions in chr7 (29% versus 42%; log-rank P = .74). The study is limited by the small sample size. A larger, prospective study is warranted to validate our findings in light of recent improvement in transplant modalities and outcomes. Copyright © 2018. Published by Elsevier Inc.

Validation of "nine equivalents of nursing manpower use score" on an independent data sample.

PubMed

Rothen, H U; Küng, V; Ryser, D H; Zürcher, R; Regli, B

1999-06-01

To compare the recently developed "nine equivalents of nursing manpower use score" (NEMS) with the simplified Therapeutic Intervention Scoring System (TISS-28). Prospective single centre study. Adult 30-bed medical-surgical intensive care unit (ICU) in a tertiary care university hospital. Data from all patients admitted in 1997 to the ICU were included in the study. NEMS and TISS-28 items were recorded prospectively for each nursing shift. There were three shifts per day. The Simplified Acute Physiology Score (SAPS) II was calculated for the first 24 h of ICU stay and each patient's basic demographic data were collected. The agreement between NEMS and TISS-28 was assessed by calculating the mean difference and the standard deviation of the differences between the two measures. Further, regression techniques and Pearson's correlation were used. Altogether, 2743 patients with a total of 28,220 nursing shifts were included; 62% of the shifts were used for postoperative/trauma patients and 38% for medical patients. Mean NEMS was 26.0 +/- 8.1 and mean TISS-28 was 26.5 +/- 7.9. The scores differed by < or = 3 points in 49 % of all shifts. The bias was -0.5 +/- 5.3 (95% confidence interval -0.47 to -0.60) and the limits of agreement were -11.1 to +10.1. The relation between the two systems was NEMS = 4.7 +/- 0.8 x TISS-28 (r = 0.78, r2 = 0.62, p < 0.001). Including postoperative/trauma patients only: NEMS = 1.9 +/- 0.9 x TISS-28, for medical patients this equation was: NEMS = 6.0 + 0.8 x TISS-28. First-day SAPS II explained 11% of the variability in first-shift NEMS and 5% of the variability in first-shift TISS-28. This study confirms a good agreement between TISS-28 and NEMS in a large, independent sample. However, as shown by the differences between medical and postoperative/trauma patients, a change in case mix may result in different regression equations. Further, wide limits of agreement indicate that there may be a rather large variability between the two measures at the individual level.

Management of Pulmonary Nodules by Community Pulmonologists: A Multicenter Observational Study.

PubMed

Tanner, Nichole T; Aggarwal, Jyoti; Gould, Michael K; Kearney, Paul; Diette, Gregory; Vachani, Anil; Fang, Kenneth C; Silvestri, Gerard A

2015-12-01

Pulmonary nodules (PNs) are a common reason for referral to pulmonologists. The majority of data for the evaluation and management of PNs is derived from studies performed in academic medical centers. Little is known about the prevalence and diagnosis of PNs, the use of diagnostic testing, or the management of PNs by community pulmonologists. This multicenter observational record review evaluated 377 patients aged 40 to 89 years referred to 18 geographically diverse community pulmonary practices for intermediate PNs (8-20 mm). Study measures included the prevalence of malignancy, procedure/test use, and nodule pretest probability of malignancy as calculated by two previously validated models. The relationship between calculated pretest probability and management decisions was evaluated. The prevalence of malignancy was 25% (n = 94). Nearly one-half of the patients (46%, n = 175) had surveillance alone. Biopsy was performed on 125 patients (33.2%). A total of 77 patients (20.4%) underwent surgery, of whom 35% (n = 27) had benign disease. PET scan was used in 141 patients (37%). The false-positive rate for PET scan was 39% (95% CI, 27.1%-52.1%). Pretest probability of malignancy calculations showed that 9.5% (n = 36) were at a low risk, 79.6% (n = 300) were at a moderate risk, and 10.8% (n = 41) were at a high risk of malignancy. The rate of surgical resection was similar among the three groups (17%, 21%, 17%, respectively; P = .69). A substantial fraction of intermediate-sized nodules referred to pulmonologists ultimately prove to be lung cancer. Despite advances in imaging and nonsurgical biopsy techniques, invasive sampling of low-risk nodules and surgical resection of benign nodules remain common, suggesting a lack of adherence to guidelines for the management of PNs.

Intradialytic Laughter Yoga therapy for haemodialysis patients: a pre-post intervention feasibility study.

PubMed

Bennett, Paul N; Parsons, Trisha; Ben-Moshe, Ros; Neal, Merv; Weinberg, Melissa K; Gilbert, Karen; Ockerby, Cherene; Rawson, Helen; Herbu, Corinne; Hutchinson, Alison M

2015-06-09

Laughter Yoga consists of physical exercise, relaxation techniques and simulated vigorous laughter. It has been associated with physical and psychological benefits for people in diverse clinical and non-clinical settings, but has not yet been tested in a haemodialysis setting. The study had three aims: 1) to examine the feasibility of conducting Laughter Yoga for patients with end stage kidney disease in a dialysis setting; 2) to explore the psychological and physiological impact of Laughter Yoga for these patients; and 3) to estimate the sample size required for future research. Pre/post intervention feasibility study. Eighteen participants were recruited into the study and Laughter Yoga therapists provided a four week intradialytic program (30-min intervention three times per week). Primary outcomes were psychological items measured at the first and last Laughter Yoga session, including: quality of life; subjective wellbeing; mood; optimism; control; self-esteem; depression, anxiety and stress. Secondary outcomes were: blood pressure, intradialytic hypotensive episodes and lung function (forced expiratory volume). Dialysis nurses exposed to the intervention completed a Laughter Yoga attitudes and perceptions survey (n = 11). Data were analysed using IBM SPSS Statistics v22, including descriptive and inferential statistics, and sample size estimates were calculated using G*Power. One participant withdrew from the study for medical reasons that were unrelated to the study during the first week (94 % retention rate). There were non-significant increases in happiness, mood, and optimism and a decrease in stress. Episodes of intradialytic hypotension decreased from 19 pre and 19 during Laughter Yoga to 4 post Laughter Yoga. There was no change in lung function or blood pressure. All nurses agreed or strongly agreed that Laughter Yoga had a positive impact on patients' mood, it was a feasible intervention and they would recommend Laughter Yoga to their patients. Sample size calculations for future research indicated that a minimum of 207 participants would be required to provide sufficient power to detect change in key psychological variables. This study provides evidence that Laughter Yoga is a safe, low-intensity form of intradialytic physical activity that can be successfully implemented for patients in dialysis settings. Larger studies are required, however, to determine the effect of Laughter Yoga on key psychological variables. Australian New Zealand Clinical Trials Registry - ACTRN12614001130651 . Registered 23 October 2014.

Quantitative evaluation of capillaroscopic microvascular changes in patients with established coronary heart disease.

PubMed

Sanchez-Garcia, M Esther; Ramirez-Lara, Irene; Gomez-Delgado, Francisco; Yubero-Serrano, Elena M; Leon-Acuña, Ana; Marin, Carmen; Alcala-Diaz, Juan F; Camargo, Antonio; Lopez-Moreno, Javier; Perez-Martinez, Pablo; Tinahones, Francisco José; Ordovas, Jose M; Caballero, Javier; Blanco-Molina, Angeles; Lopez-Miranda, Jose; Delgado-Lista, Javier

2018-02-23

Microcirculation disturbances have been associated to most of the cardiovascular risk factors as well as to multiple inflammatory diseases. However, whether these abnormalities are specifically augmented in patients with coronary heart disease is still unknown. We aimed to evaluate if there is a relationship between the presence of coronary heart disease and the existence of functional and structural capillary abnormalities evaluated in the cutaneous microcirculation by videocapillaroscopy. Two matched samples of 30 participants with and without coronary heart disease but with similar clinical and anthropometric characteristics were evaluated by videocapillaroscopy at the dorsal skin of the third finger of the non-dominant hand. We calculated basal capillary density as well as capillary density after a period of arterial and venous occlusion in order to evaluate functionality and maximum capillary density. We also measured capillary recruitment. Microvascular capillary density at rest was significantly lower in patients suffering from coronary heart disease than in controls. This fact was also found after dynamic tests (arterial and venous occlusion), suggesting functional impairments. Capillary recruitment of the samples was not different in our sample. In our study, patients with coronary heart disease exhibit functional and structural microvascular disturbances. Although this is a very preliminary study, these findings open the door for further studying the microvascular functionality in coronary patients and how it relates to the response to treatment and/or the prognosis of the disease. Copyright © 2017 Elsevier España, S.L.U. All rights reserved.

Patient adherence to transdermal rivastigmine after switching from oral donepezil: a retrospective claims database study.

PubMed

Tian, Haijun; Abouzaid, Safiya; Chen, Wei; Kahler, Kristijan H; Kim, Edward

2013-01-01

To examine patient adherence before and after switching from donepezil to the rivastigmine patch. This retrospective cohort study used the MarketScan Commercial and Medicare data sets (2004 to 2009). Patients with a diagnosis of Alzheimer disease who were new donepezil users and were subsequently switched to the rivastigmine patch were included. The proportion of days covered (PDC) and PDC difference between donepezil and the rivastigmine patch were calculated from the time of initiation to the switch, capped at 1 year after the first respective claim. PDC was calculated as the number of days with drugs available divided by the number of days in the respective follow-up periods. The sample included 772 patients (mean age 77 y; 58% female). The mean time between switching from donepezil to the rivastigmine patch was 579 (SD=317.3) days. The mean PDC for the rivastigmine patch was highest among patients who switched within 3 months (80.4% vs. 90.7%; P=0.04) and within 7 to 9 months (61.3% vs. 71.0%; P=0.05) of initiating donepezil. When adherence was analyzed in increments of 1 year, patients who switched to the rivastigmine patch within the first year of treatment had significantly greater adherence to rivastigmine compared with those who were on donepezil (PDC 69.3% vs. 60.6%; P=0.0004). Switching from donepezil to the rivastigmine patch seems to be associated with increased adherence, especially in patients who switched within the first year of initiating donepezil.

Evaluation of oxidative status in patients with brucellosis.

PubMed

Serefhanoglu, Kivanc; Taskin, Abdullah; Turan, Hale; Timurkaynak, Funda Ergin; Arslan, Hande; Erel, Ozcan

2009-08-01

Oxidative stress can be defined as an increase in oxidants and/or a decrease in antioxidant capacity. We aimed to determine total antioxidant capacity (TAC), total peroxide, malondialdehyde and catalase levels in plasma samples, and calculation of oxidative stress index (OSI) in patients with brucellosis to evaluate their oxidative status using a novel automated method. Sixty-nine patients with brucellosis and 69 healthy control subjects were included in the present study. Plasma levels of total peroxide and malondialdehyde were significantly increased in patients as compared with healthy controls (p<0.001 and p<0.001, respectively). In contrast, TAC level was significantly lower in patients as compared with controls (p<0.001). There was no statistically significant difference between the catalase results of the two groups (p>0.05). OSI level was significantly increased in patients as compared with healthy controls (p<0.001). In conclusion, oxidants were increased and antioxidants were decreased in patients with brucellosis. Oxidative stress was increased in patients with brucellosis.

Kisspeptin and LH pulsatile temporal coupling in PCOS patients.

PubMed

Katulski, Krzysztof; Podfigurna, Agnieszka; Czyzyk, Adam; Meczekalski, Blazej; Genazzani, Alessandro D

2018-05-04

To evaluate the temporal coupling between spontaneous kisspeptin and luteinizing hormone (LH) pulsatile releases in polycystic ovary syndrome (PCOS) patients. We examined 71 patients diagnosed with PCOS. A 2 h pulsatility study was performed to evaluate serum kisspeptin and LH pulse frequency and concentration, sampled every 10 min; baseline follicle-stimulating hormone (FSH), estradiol (E2), prolactin (PRL), cortisol, 17-hydroksy-progesterone (17OHP), testosterone (T), free testosterone index (FTI, and insulin levels were also measured. Detect and Specific Concordance (SC) algorithms were used to evaluate the temporal coupling associations between spontaneous episodic secretion of kisspeptin and LH. All PCOS patients demonstrated LH and kisspeptin pulsatile secretions. When the SC index was calculated across the sample of PCOS patients (n = 71), no temporal coupling was observed between kisspeptin and LH pulses. When PCOS patients were subdivided according to their menstrual cyclicity, oligomenorrheic patients demonstrated elevated kisspeptin pulse frequency. Additionally, the SC index reveled a temporal coupling between kisspeptin and LH secretory peaks only in eumenorrheic patients (n = 30, intermenstrual interval < 45 days). Oligomenorrheic PCOS patients (intermenstrual interval > 45 days) did not demonstrate temporal coupling between kisspeptin and LH secretory peaks. The study of the endogenous kisspeptin and LH pulsatile release revealed the temporal coupling of kisspeptin with LH secretory pulses only in eumenorrheic. This data supports the hypothesis that neuroendocrine impairments in PCOS affect the coupling of kisspeptin with LH pulses and potentially worsen as the disease progresses, becoming unequivocally evident in oligomenorrheic PCOS patients.

Agreement Rate of Rapid Urease Test, Conventional PCR, and Scorpion Real-Time PCR in Detecting Helicobacter Pylori from Tonsillar Samples of Patients with Chronic Tonsillitis

PubMed Central

Najafipour, Reza; Farivar, Taghi Naserpour; Pahlevan, Ali Akbar; Johari, Pouran; Safdarian, Farshid; Asefzadeh, Mina

2012-01-01

Background: Helicobacter pylori is capable of inducing systemic inflammatory reactions through immunological processes. There are several methods to identify the presence of H. pylori in clinical samples including rapid urease test (RUT), conventional polymerase chain reaction (PCR), and the Scorpion real-time PCR. Aim: The aim of the present study is to compare the agreement rate of these tests in identifying H. pylori in tonsillar biopsy specimens collected from patients with chronic tonsillitis. Materials and Methods: A total of 103 tonsil biopsy samples from patients with clinical signs of chronic tonsillitis were examined with RUT, PCR, and Scorpion real-time PCR. The degree of agreement between the three tests was later calculated. Results: There was a poor degree of agreement between RUT and PCR and also RUT and Scorpion real-time PCR (Kappa=0.269 and 0.249, respectively). In contrast with RUT, there was a strong degree of agreement between PCR and Scorpion real-time PCR (Kappa=0.970). Conclusion: The presence of a strong agreement between the Scorpion real-time PCR and PCR as well as its technical advantage over the conventional PCR assay, made the Scorpion real-time PCR an appropriate laboratory test to investigate the presence of H. pylori in tonsillar biopsy specimens in patients suffering from chronic tonsillitis. PMID:22754245

Effect of patient selection method on provider group performance estimates.

PubMed

Thorpe, Carolyn T; Flood, Grace E; Kraft, Sally A; Everett, Christine M; Smith, Maureen A

2011-08-01

Performance measurement at the provider group level is increasingly advocated, but different methods for selecting patients when calculating provider group performance have received little evaluation. We compared 2 currently used methods according to characteristics of the patients selected and impact on performance estimates. We analyzed Medicare claims data for fee-for-service beneficiaries with diabetes ever seen at an academic multispeciality physician group in 2003 to 2004. We examined sample size, sociodemographics, clinical characteristics, and receipt of recommended diabetes monitoring in 2004 for the groups of patients selected using 2 methods implemented in large-scale performance initiatives: the Plurality Provider Algorithm and the Diabetes Care Home method. We examined differences among discordantly assigned patients to determine evidence for differential selection regarding these measures. Fewer patients were selected under the Diabetes Care Home method (n=3558) than the Plurality Provider Algorithm (n=4859). Compared with the Plurality Provider Algorithm, the Diabetes Care Home method preferentially selected patients who were female, not entitled because of disability, older, more likely to have hypertension, and less likely to have kidney disease and peripheral vascular disease, and had lower levels of predicted utilization. Diabetes performance was higher under Diabetes Care Home method, with 67% versus 58% receiving >1 A1c tests, 70% versus 65% receiving ≥1 low-density lipoprotein (LDL) test, and 38% versus 37% receiving an eye examination. The method used to select patients when calculating provider group performance may affect patient case mix and estimated performance levels, and warrants careful consideration when comparing performance estimates.

Epigenetic Silencing of the MLH1 Promoter in Relation to the Development of Gastric Cancer and its use as a Biomarker for Patients with Microsatellite Instability: a Systematic Analysis.

PubMed

Hu, Guimei; Qin, Lijun; Zhang, Xinjun; Ye, Guoliang; Huang, Tao

2018-01-01

Human mutL homolog 1 (MLH1) promoter methylation was reported in gastric cancer (GC). This study determined the clinicopathological, prognostic, and diagnostic effects of MLH1 promoter methylation in GC. The combined odds ratio (OR) or hazard ratio (HR) and their corresponding 95% confidence intervals (95% CI) were calculated. The pooled sensitivity, specificity, and area under the curve (AUC) were analyzed. A total of 4654 GC patients and 3669 non-malignant controls were identified in this systematic analysis. MLH1 promoter methylation was significantly higher in GC samples than in gastric adenomas, chronic gastritis, adjacent tissues, normal gastric mucosa, and normal healthy blood samples, but it exhibited a similar frequency in GC vs. intestinal metaplasia and dysplasia samples. MLH1 promoter methylation correlated with age and microsatellite instability (MSI), but it was not associated with gender, H. pylori infection, smoking, drinking behaviors, pathological histology, tumor differentiation, clinical stage, lymph node status, distant metastasis, or overall survival of GC. MLH1 promoter methylation exhibited a poor sensitivity value (< 0.5) in patients with GC compared with adjacent tissues, gastric adenomas, chronic gastritis, normal gastric mucosa, and normal healthy blood samples. The pooled sensitivity, specificity, and AUC of MLH1 promoter methylation in GC with MSI vs. GC with microsatellite stability (MSS) samples were 0.64, 0.96, and 0.90, respectively. Our results suggest that the detection of MLH1 promoter methylation may be a potential prognostic biomarker for GC patients with MSI. © 2018 The Author(s). Published by S. Karger AG, Basel.

Evaluation of the Correlation Coefficient of Polyethylene Glycol Treated and Direct Prolactin Results and Comparability with Different Assay System Results.

PubMed

Pal, Shyamali

2017-12-01

The presence of Macro prolactin is a significant cause of elevated prolactin resulting in misdiagnosis in all automated systems. Poly ethylene glycol (PEG) pretreatment is the preventive process but such process includes the probability of loss of a fraction of bioactive prolactin. Surprisingly, PEG treated EQAS & IQAS samples in Cobas e 411 are found out to be correlating with direct results of at least 3 immunoassay systems and treated and untreated Cobas e 411 results are comparable by a correlation coefficient. Comparison of EQAS, IQAS and patient samples were done to find out the trueness of such correlation factor. Study with patient's results have established the correlation coefficient is valid for very small concentration of prolactin also. EQAS, IQAS and 150 patient samples were treated with PEG and prolactin results of treated and untreated samples obtained from Roche Cobas e 411. 25 patient's results (treated) were compared with direct results in Advia Centaur, Architect I & Access2 systems. Correlation coefficient was obtained from trend line of the treated and untreated results. Two tailed p-value obtained from regression coefficient(r) and sample size. The correlation coefficient is in the range (0.761-0.771). Reverse correlation range is (1.289-1.301). r value of two sets of calculated results were 0.995. Two tailed p- value is zero approving dismissal of null hypothesis. The z-score of EQAS does not always assure authenticity of resultsPEG precipitation is correlated by the factor 0.761 even in very small concentrationsAbbreviationsGFCgel filtration chromatographyPEGpolyethylene glycolEQASexternal quality assurance systemM-PRLmacro prolactinPRLprolactinECLIAelectro-chemiluminescence immunoassayCLIAclinical laboratory improvement amendmentsIQASinternal quality assurance systemrregression coefficient.

High frequency of primary hyperaldosteronism among hypertensive patients from a primary care area in Sweden.

PubMed

Westerdahl, Christina; Bergenfelz, Anders; Isaksson, Anders; Wihl, Anders; Nerbrand, Christina; Valdemarsson, Stig

2006-09-01

To search for primary hyperaldosteronism (PHA) among previously known hypertensive patients in primary care, using the aldosterone/renin ratio (ARR), and to evaluate clinical and biochemical characteristics in patients with high or normal ratio. Patient survey study. The study population was recruited by written invitation among hypertensive patients in two primary care areas in Sweden. A total of 200 patients met the criteria and were included in the study. The ARR was calculated from serum aldosterone and plasma renin concentrations. The cut-off level for ARR was set to 100, as confirmed in 28 healthy subjects. Patients with increased ARR were considered for a confirmatory test, using the fludrocortisone suppression test. Of 200 patients, 50 patients had ARR > 100; 26 patients were further evaluated by fludrocortisone suppression test. Seventeen of these patients had an incomplete aldosterone inhibition. In total 17 of 200 evaluated patients (8.5%) had an incomplete suppression with fludrocortisone. This confirms previous reports on a high frequency of PHA. No significant biochemical or clinical differences were found among hypertensive patients with PHA compared with the whole sample.

The effects of intra-fraction organ motion on the delivery of intensity-modulated field with a multileaf collimator.

PubMed

Chui, Chen-Shou; Yorke, Ellen; Hong, Linda

2003-07-01

Intensity-modulated radiation therapy can be conveniently delivered with a multileaf collimator. With this method, the entire field is not delivered at once, but rather it is composed of many subfields defined by the leaf positions as a function of beam on time. At any given instant, only these subfields are delivered. During treatment, if the organ moves, part of the volume may move in or out of these subfields. Due to this interplay between organ motion and leaf motion the delivered dose may be different from what was planned. In this work, we present a method that calculates the effects of organ motion on delivered dose. The direction of organ motion may be parallel or perpendicular to the leaf motion, and the effect can be calculated for a single fraction or for multiple fractions. Three breast patients and four lung patients were included in this study,with the amplitude of the organ motion varying from +/- 3.5 mm to +/- 10 mm, and the period varying from 4 to 8 seconds. Calculations were made for these patients with and without organ motion, and results were examined in terms of isodose distribution and dose volume histograms. Each calculation was repeated ten times in order to estimate the statistical uncertainties. For selected patients, calculations were also made with conventional treatment technique. The effects of organ motion on conventional techniques were compared relative to that on IMRT techniques. For breast treatment, the effect of organ motion primarily broadened the penumbra at the posterior field edge. The dose in the rest of the treatment volume was not significantly affected. For lung treatment, the effect also broadened the penumbra and degraded the coverage of the planning target volume (PTV). However, the coverage of the clinical target volume (CTV) was not much affected, provided the PTV margin was adequate. The same effects were observed for both IMRT and conventional treatment techniques. For the IMRT technique, the standard deviations of ten samples of a 30-fraction calculation were very small for all patients, implying that over a typical treatment course of 30 fractions, the delivered dose was very close to the expected value. Hence, under typical clinical conditions, the effect of organ motion on delivered dose can be calculated without considering the interplay between the organ motion and the leaf motion. It can be calculated as the weighted average of the dose distribution without organ motion with the distribution of organ motion. Since the effects of organ motion on dose were comparable for both IMRT and conventional techniques, the PTV margin should remain the same for both techniques.

Universal multiplex PCR and CE for quantification of SMN1/SMN2 genes in spinal muscular atrophy.

PubMed

Wang, Chun-Chi; Chang, Jan-Gowth; Jong, Yuh-Jyh; Wu, Shou-Mei

2009-04-01

We established a universal multiplex PCR and CE to calculate the copy number of survival motor neuron (SMN1 and SMN2) genes for clinical screening of spinal muscular atrophy (SMA). In this study, one universal fluorescent primer was designed and applied for multiplex PCR of SMN1, SMN2 and two internal standards (CYBB and KRIT1). These amplicons were separated by conformation sensitive CE. Mixture of hydroxyethyl cellulose and hydroxypropyl cellulose were used in this CE system. Our method provided the potential to separate two 390-bp PCR products that differ in a single nucleotide. Differentiation and quantification of SMN1 and SMN2 are essential for clinical screening of SMA patients and carriers. The DNA samples included 22 SMA patients, 45 parents of SMA patients (obligatory carriers) and 217 controls. For evaluating accuracy, those 284 samples were blind-analyzed by this method and denaturing high pressure liquid chromatography (DHPLC). Eight of the total samples showed different results. Among them, two samples were diagnosed as having only SMN2 gene by DHPLC, however, they contained both SMN1 and SMN2 by our method. They were further confirmed by DNA sequencing. Our method showed good agreement with the DNA sequencing. The multiplex ligation-dependent probe amplification (MLPA) was used for confirming the other five samples, and showed the same results with our CE method. For only one sample, our CE showed different results with MLPA and DNA sequencing. One out of 284 samples (0.35%) belonged to mismatching. Our method provided a better accurate method and convenient method for clinical genotyping of SMA disease.

Assessment of Type I Interferon Signaling in Pediatric Inflammatory Disease.

PubMed

Rice, Gillian I; Melki, Isabelle; Frémond, Marie-Louise; Briggs, Tracy A; Rodero, Mathieu P; Kitabayashi, Naoki; Oojageer, Anthony; Bader-Meunier, Brigitte; Belot, Alexandre; Bodemer, Christine; Quartier, Pierre; Crow, Yanick J

2017-02-01

Increased type I interferon is considered relevant to the pathology of a number of monogenic and complex disorders spanning pediatric rheumatology, neurology, and dermatology. However, no test exists in routine clinical practice to identify enhanced interferon signaling, thus limiting the ability to diagnose and monitor treatment of these diseases. Here, we set out to investigate the use of an assay measuring the expression of a panel of interferon-stimulated genes (ISGs) in children affected by a range of inflammatory diseases. A cohort study was conducted between 2011 and 2016 at the University of Manchester, UK, and the Institut Imagine, Paris, France. RNA PAXgene blood samples and clinical data were collected from controls and symptomatic patients with a genetically confirmed or clinically well-defined inflammatory phenotype. The expression of six ISGs was measured by quantitative polymerase chain reaction, and the median fold change was used to calculate an interferon score (IS) for each subject compared to a previously derived panel of 29 controls (where +2 SD of the control data, an IS of >2.466, is considered as abnormal). Results were correlated with genetic and clinical data. Nine hundred ninety-two samples were analyzed from 630 individuals comprising symptomatic patients across 24 inflammatory genotypes/phenotypes, unaffected heterozygous carriers, and controls. A consistent upregulation of ISG expression was seen in 13 monogenic conditions (455 samples, 265 patients; median IS 10.73, interquartile range (IQR) 5.90-18.41), juvenile systemic lupus erythematosus (78 samples, 55 patients; median IS 10.60, IQR 3.99-17.27), and juvenile dermatomyositis (101 samples, 59 patients; median IS 9.02, IQR 2.51-21.73) compared to controls (78 samples, 65 subjects; median IS 0.688, IQR 0.427-1.196), heterozygous mutation carriers (89 samples, 76 subjects; median IS 0.862, IQR 0.493-1.942), and individuals with non-molecularly defined autoinflammation (89 samples, 69 patients; median IS 1.07, IQR 0.491-3.74). An assessment of six ISGs can be used to define a spectrum of inflammatory diseases related to enhanced type I interferon signaling. If future studies demonstrate that the IS is a reactive biomarker, this measure may prove useful both in the diagnosis and the assessment of treatment efficacy.

The importance of having a flexible scope ISO 15189 accreditation and quality specifications based on biological variation--the case of validation of the biochemistry analyzer Dimension Vista.

PubMed

Fernandez-Calle, Pilar; Pelaz, Sandra; Oliver, Paloma; Alcaide, Maria Jose; Gomez-Rioja, Ruben; Buno, Antonio; Iturzaeta, Jose Manuel

2013-01-01

Technological innovation requires the laboratories to ensure that modifications or incorporations of new techniques do not alter the quality of their results. In an ISO 15189 accredited laboratory, flexible scope accreditation facilitates the inclusion of these changes prior to accreditation body evaluation. A strategy to perform the validation of a biochemistry analyzer in an accredited laboratory having a flexible scope is shown. A validation procedure including the evaluation of imprecision and bias of two Dimension Vista analysers 1500 was conducted. Comparability of patient results between one of them and the lately replaced Dimension RxL Max was evaluated. All studies followed the respective Clinical and Laboratory Standards Institute (CLSI) protocols. 30 chemistry assays were studied. Coefficients of variation, percent bias and total error were calculated for all tests and biological variation was considered as acceptance criteria. Quality control material and patient samples were used as test materials. Interchangeability of the results was established by processing forty patients' samples in both devices. 27 of the 30 studied parameters met allowable performance criteria. Sodium, chloride and magnesium did not fulfil acceptance criteria. Evidence of interchangeability of patient results was obtained for all parameters except magnesium, NT-proBNP, cTroponin I and C-reactive protein. A laboratory having a well structured and documented validation procedure can opt to get a flexible scope of accreditation. In addition, performing these activities prior to use on patient samples may evidence technical issues which must be corrected to minimize their impact on patient results.

Average of delta: a new quality control tool for clinical laboratories.

PubMed

Jones, Graham R D

2016-01-01

Average of normals is a tool used to control assay performance using the average of a series of results from patients' samples. Delta checking is a process of identifying errors in individual patient results by reviewing the difference from previous results of the same patient. This paper introduces a novel alternate approach, average of delta, which combines these concepts to use the average of a number of sequential delta values to identify changes in assay performance. Models for average of delta and average of normals were developed in a spreadsheet application. The model assessed the expected scatter of average of delta and average of normals functions and the effect of assay bias for different values of analytical imprecision and within- and between-subject biological variation and the number of samples included in the calculations. The final assessment was the number of patients' samples required to identify an added bias with 90% certainty. The model demonstrated that with larger numbers of delta values, the average of delta function was tighter (lower coefficient of variation). The optimal number of samples for bias detection with average of delta was likely to be between 5 and 20 for most settings and that average of delta outperformed average of normals when the within-subject biological variation was small relative to the between-subject variation. Average of delta provides a possible additional assay quality control tool which theoretical modelling predicts may be more valuable than average of normals for analytes where the group biological variation is wide compared with within-subject variation and where there is a high rate of repeat testing in the laboratory patient population. © The Author(s) 2015.

Calculation of Blood Dose in Patients Treated With 131I Using MIRD, Imaging, and Blood Sampling Methods.

PubMed

Piruzan, Elham; Haghighatafshar, Mahdi; Faghihi, Reza; Entezarmahdi, Seyed Mohammad

2016-03-01

Radioiodine therapy is known as the most effective treatment of differentiated thyroid carcinoma (DTC) to ablate remnant thyroid tissue after surgery. In patients with DTC treated with radioiodine, internal radiation dosimetry of radioiodine is useful for radiation risk assessment. The aim of this study is to describe a method to estimate the absorbed dose to the blood using medical internal radiation dosimetry methods. In this study, 23 patients with DTC with different administrated activities, 3.7, 4.62, and 5.55 GBq after thyroidectomy, were randomly selected. Blood dosimetry of treated patients was performed with external whole body counting using a dual-head gamma camera imaging device and also with blood sample activity measurements using a dose calibrator. Absorbed dose to the blood was measured at 2, 6, 12, 24, 48, and 96 hours after the administration of radioiodine with the 2 methods. Based on the results of whole body counting and blood sample activity dose rate measurements, 96 hours after administration of 3.7, 4.62, and 5.55 GBq of radioiodine, absorbed doses to patients' blood were 0.65 ± 0.20, 0.67 ± 0.18, 0.79 ± 0.51 Gy, respectively. Increasing radioiodine activity from 3.7 to 5.55 GBq increased blood dose significantly, while there was no significant difference in blood dose between radioiodine dosages of 3.7 and 4.62 GBq. Our results revealed a significant correlation between the blood absorbed dose and blood sample activity and between the blood absorbed dose and whole body counts 24 to 48 hours after the administration of radioiodine.

Se status in normal and pathological human individuals before and after Se supplementation

NASA Astrophysics Data System (ADS)

Bellisola, G.; Cinque, G.; Galassini, S.; Guidi, G. C.; Liu, N. Q.; Moschini, G.

1996-04-01

The determination of selenium in plasma and in urine samples has been suggested for the assessment of Se status in human individuals. The kidney is of fundamental importance in Se homeostasis: with low Se intake its excretion will be decreased and with high Se intake it will be increased. In 21 patients with kidney disease (8 with normal kidney function and 13 with moderate renal failure) Se was measured in 1 ml of urine by PIXE after preconcentration of the sample. The total urine volume was measured to calculate total daily Se excretion. The same procedure was applied to 14 normal individuals for comparison. All individuals were then supplemented orally with selenite for 8 weeks (Se = 600 μg/day) and the procedure was repeated. The behaviour of the major selenoproteins was also investigated by measuring glutathione peroxidase activities in plasma, in platelets and in erythrocyte samples. For renal function, serum and urine creatinine concentrations were utilised and creatinine clearances were calculated. Results obtained were compared before and after Se treatment and between groups. Some correlation studies were carried out between Se and kidney functions and/or selenoperoxidase activities.

Headache and temporo mandibular disorders: epidemiological assessment.

PubMed

D'Urso, Anna; Serritella, Emanuela; Tolevski Meshkova, Doria; Falisi, Giovanni; Di Paolo, Carlo

2016-04-01

Temporo mandibular disorders (TMDs) and headache are closely related pathologies. The aim of this study was to determine the prevalence, incidence, and the intensity of headache in 3304 dysfunctional patients (G1) at the Service of Clinical Gnathology of the Head-Neck Assistance Department of Umberto I Polyclinic at Sapienza University of Rome. G1 is composed by two subgroups of patient S1 (N.=2375) and S2 (N.=929) analyzed in different periods, respectively 1996-2006 and 2011-2013. The findings were compared with those of a control group of subjects from the general Italian population recently reported elsewhere. The prevalence of headache in the dysfunctional population was analyzed by calculating the proportion of that population who tested positive to cephalic pain for the entire study period. The incidence of headache has been calculated by determining the proportion cases of headache in TMD population, during the period analyzed among those considered at risk at the beginning of the examination period. The intensity of cephalic pain was evaluated using the Verbal Numeric Scale. Confidence Intervals (CI) at the 95% confidence level were calculated to get a precise estimate of research data. Comparison of G1 and control sample did not reveal many important differences, respectively with a headache prevalence of 49.5% (95%CI 47.8%-51.2%) and 42.8%(95%CI 46.8-38.8%). However, comparison of S1, which constituted a sample similar in numbers to the control sample and was observed during a similar time period, revealed a clearly greater prevalence of headache in the dysfunctional population 67.3% (95%CI 64.3-70.3%) than in the general representative population of Italian people 42.8% (95%CI 46.8-38.8%). The incidence of headache in the dysfunctional population was 39.49% (95%CI 37.79-41.19%). Headache incidence in the first subgroup (S1) was 32.7%(95%CI 34.6-30.8%), while in S2 was 59.24%(95%CI 56.24-62.24%), demonstrating an increase of incidence in the second subgroup analyzed. In G1 the average intensity of headache was severe (VNS>50). Headache is more intense in dysfunctional patients of the second subgroups (S2) than the first subgroup (S1) VNS 24.91 (95%CI 23.11-26.71) vs. 70.00 (95%CI 67.0-73.0). These findings confirm the existence of a relationship between headache and TMDs, showing that a dysfunctional patient has a greater predisposition to headache than a non-dysfunctional subject.

More experiences with the Tzanck smear test: cytologic findings in cutaneous granulomatous disorders.

PubMed

Durdu, Murat; Baba, Mete; Seçkin, Deniz

2009-09-01

Granulomatous dermatitis is a distinctive histopathologic cutaneous reaction pattern against various infectious and noninfectious agents. Cytologically, granulomatous dermatitis shows granulomas and multinucleated giant cells. Various etiologic agents of granulomatous diseases can also be identified. We aimed to investigate Tzanck smear findings in granulomatous skin diseases. Patients who had granulomas and/or multinucleated giant cells of Langhans, foreign body- and/or Touton type in Tzanck smear tests were included in the study. In these patients, Tzanck preparations were then further evaluated for additional cytologic findings. Samples stained with May-Grünwald-Giemsa stain were evaluated by the same dermatologist throughout the study. In some patients, methylene blue, Gram and/or Erlich-Ziehl-Nielsen stains were also performed. In all of the study cases, the final diagnosis was established after the evaluation of clinical and laboratory findings (including, when appropriate, potassium hydroxide examination; bacterial, leishmanial, and fungal cultures; histopathology; tuberculosis and leishmania polymerase chain reaction). We also calculated the sensitivity and specificity of the Leishman-Donovan body for cutaneous leishmaniasis. Over a 2-year period, 94 of 950 patients (9.9%) in whom Tzanck smear tests were performed had cytologic findings consistent with a granulomatous reaction. In 74 (78.7%) and 20 (21.3%) patients, the granulomatous reaction was due to infectious and noninfectious causes, respectively. Infectious causes included cutaneous leishmaniasis in 65 patients (87.8%), candidal granuloma in two patients, botyromycosis in two patients, and aspergillosis, blastomycosis, mucormycosis, leprosy, and cutaneous tuberculosis in one patient each. In 58 of 74 patients (78.4%) with infectious granulomatous dermatitis, the causes of the granulomas were identified. Noninfectious granulomatous reactions were due to granuloma annulare in 7 patients, sarcoidosis in 5 patients, a foreign body in 4 patients, necrobiosis lipoidica in 2 patients, and juvenile xanthogranuloma in 2 patients. In 17 of 20 patients (85%) with noninfectious granulomatous reactions, the cytologic findings were characteristic of the final diagnoses. The sensitivity and specificity of Leishman-Donovan bodies for cutaneous leishmaniasis were 76.9% and 100%, respectively. All of the samples were evaluated by the same dermatologist throughout the study; therefore no comment could be made regarding the reliability of the Tzanck smear test. In addition, the sensitivity and specificity of Tzanck smear test findings for diseases other than cutaneous leishmaniasis could not be calculated because of an insufficient number of patients. The Tzanck smear test may be a useful diagnostic tool for certain granulomatous skin diseases.

Long-Term Survival Prediction for Coronary Artery Bypass Grafting: Validation of the ASCERT Model Compared With The Society of Thoracic Surgeons Predicted Risk of Mortality.

PubMed

Lancaster, Timothy S; Schill, Matthew R; Greenberg, Jason W; Ruaengsri, Chawannuch; Schuessler, Richard B; Lawton, Jennifer S; Maniar, Hersh S; Pasque, Michael K; Moon, Marc R; Damiano, Ralph J; Melby, Spencer J

2018-05-01

The recently developed American College of Cardiology Foundation-Society of Thoracic Surgeons (STS) Collaboration on the Comparative Effectiveness of Revascularization Strategy (ASCERT) Long-Term Survival Probability Calculator is a valuable addition to existing short-term risk-prediction tools for cardiac surgical procedures but has yet to be externally validated. Institutional data of 654 patients aged 65 years or older undergoing isolated coronary artery bypass grafting between 2005 and 2010 were reviewed. Predicted survival probabilities were calculated using the ASCERT model. Survival data were collected using the Social Security Death Index and institutional medical records. Model calibration and discrimination were assessed for the overall sample and for risk-stratified subgroups based on (1) ASCERT 7-year survival probability and (2) the predicted risk of mortality (PROM) from the STS Short-Term Risk Calculator. Logistic regression analysis was performed to evaluate additional perioperative variables contributing to death. Overall survival was 92.1% (569 of 597) at 1 year and 50.5% (164 of 325) at 7 years. Calibration assessment found no significant differences between predicted and actual survival curves for the overall sample or for the risk-stratified subgroups, whether stratified by predicted 7-year survival or by PROM. Discriminative performance was comparable between the ASCERT and PROM models for 7-year survival prediction (p < 0.001 for both; C-statistic = 0.815 for ASCERT and 0.781 for PROM). Prolonged ventilation, stroke, and hospital length of stay were also predictive of long-term death. The ASCERT survival probability calculator was externally validated for prediction of long-term survival after coronary artery bypass grafting in all risk groups. The widely used STS PROM performed comparably as a predictor of long-term survival. Both tools provide important information for preoperative decision making and patient counseling about potential outcomes after coronary artery bypass grafting. Copyright © 2018 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

Assessment of gallstone predictor: comparative analysis of ultrasonographic and biochemical parameters

PubMed Central

2013-01-01

Background Gallstones represent a significant burden for health care systems worldwide and are one of the most common disorders presenting to emergency room. Ultrasonography, complete blood picture test and liver function tests are procedures of choice in suspected gallstones or biliary diseases. They are the most sensitive, specific, non-invasive and inexpensive tests for the detection of gallstones. Our main objective was to evaluate the relationship of ultrasonographic findings, hemolytic indices and liver function tests with gallstones. Methodology It was a prospective study carried out in Civil Hospital Karachi (DUHS) and Liaquat National Hospital, two largest tertiary care hospitals of Karachi, Pakistan. Duration of the study was from July 2011 to October 2012. The study was carried out on diagnosed, pre-operative and symptomatic patients of cholelithiases. Exclusion criteria were patients of gallbladder and pancreatic carcinoma, emergency operations, patients having age <12 years and non-cooperative patients, who refused to give written consent for participation in the study. Total two tests were performed on each patient after diagnosis by ultrasonography. These were complete blood count and liver function tests. All the demographic data, laboratory findings and ultrasonographic features were noted in a pre-structured Performa. Sample size was calculated by using open-epidemiological sample size calculator prevalence (p) = 35%, d = 5%, and confidence interval (CI) 95% = 350. All the data was entered and analyzed through SPSS 19. Result There were 454 diagnosed and pre-operative cases of gallstones present in the study. There were 120(26.4%) males and 334(73.6%) females, with a mean age of 42.80 ± 12.26 years. Most of the suspects had multiple stones 384 (84.5%) while few had single stones 70(15.4%). Fatty liver was found to be present in 144(31.7%) patients and 92(20.2%) had hepatomegaly. Splenomegaly was present in 16(3.5%) patients. Alkaline phosphatase was elevated in 186(41.0%) patients while SGPT was found to be raised in 160(35.2%). Blood urea nitrogen was found to be elevated in 186(41%) patients and serum creatinine was elevated in 46(10.1%) patients. Conclusion In the light of findings it is recommend that all patients should go through the process of ultrasonography and all the biochemical parameters should be analyzed before surgery. PMID:23618353

Assessment of gallstone predictor: comparative analysis of ultrasonographic and biochemical parameters.

PubMed

Aslam, Hafiz Muhammad; Saleem, Shafaq; Edhi, Muhammad Muzzammil; Shaikh, Hiba Arshad; Khan, Jehanzeb Daniel; Hafiz, Mehak; Saleem, Maria

2013-01-01

Gallstones represent a significant burden for health care systems worldwide and are one of the most common disorders presenting to emergency room. Ultrasonography, complete blood picture test and liver function tests are procedures of choice in suspected gallstones or biliary diseases. They are the most sensitive, specific, non-invasive and inexpensive tests for the detection of gallstones. Our main objective was to evaluate the relationship of ultrasonographic findings, hemolytic indices and liver function tests with gallstones. It was a prospective study carried out in Civil Hospital Karachi (DUHS) and Liaquat National Hospital, two largest tertiary care hospitals of Karachi, Pakistan. Duration of the study was from July 2011 to October 2012. The study was carried out on diagnosed, pre-operative and symptomatic patients of cholelithiases. Exclusion criteria were patients of gallbladder and pancreatic carcinoma, emergency operations, patients having age <12 years and non-cooperative patients, who refused to give written consent for participation in the study. Total two tests were performed on each patient after diagnosis by ultrasonography. These were complete blood count and liver function tests. All the demographic data, laboratory findings and ultrasonographic features were noted in a pre-structured Performa. Sample size was calculated by using open-epidemiological sample size calculator prevalence (p) = 35%, d = 5%, and confidence interval (CI) 95% = 350. All the data was entered and analyzed through SPSS 19. There were 454 diagnosed and pre-operative cases of gallstones present in the study. There were 120(26.4%) males and 334(73.6%) females, with a mean age of 42.80 ± 12.26 years. Most of the suspects had multiple stones 384 (84.5%) while few had single stones 70(15.4%). Fatty liver was found to be present in 144(31.7%) patients and 92(20.2%) had hepatomegaly. Splenomegaly was present in 16(3.5%) patients. Alkaline phosphatase was elevated in 186(41.0%) patients while SGPT was found to be raised in 160(35.2%). Blood urea nitrogen was found to be elevated in 186(41%) patients and serum creatinine was elevated in 46(10.1%) patients. In the light of findings it is recommend that all patients should go through the process of ultrasonography and all the biochemical parameters should be analyzed before surgery.

[Interpreting change scores of the Behavioural Rating Scale for Geriatric Inpatients (GIP)].

PubMed

Diesfeldt, H F A

2013-09-01

The Behavioural Rating Scale for Geriatric Inpatients (GIP) consists of fourteen, Rasch modelled subscales, each measuring different aspects of behavioural, cognitive and affective disturbances in elderly patients. Four additional measures are derived from the GIP: care dependency, apathy, cognition and affect. The objective of the study was to determine the reproducibility of the 18 measures. A convenience sample of 56 patients in psychogeriatric day care was assessed twice by the same observer (a professional caregiver). The median time interval between rating occasions was 45 days (interquartile range 34-58 days). Reproducibility was determined by calculating intraclass correlation coefficients (ICC agreement) for test-retest reliability. The minimal detectable difference (MDD) was calculated based on the standard error of measurement (SEM agreement). Test-retest reliability expressed by the ICCs varied from 0.57 (incoherent behaviour) to 0.93 (anxious behaviour). Standard errors of measurement varied from 0.28 (anxious behaviour) to 1.63 (care dependency). The results show how the GIP can be applied when interpreting individual change in psychogeriatric day care participants.

40 CFR 89.418 - Raw emission sampling calculations.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 20 2011-07-01 2011-07-01 false Raw emission sampling calculations. 89... Test Procedures § 89.418 Raw emission sampling calculations. (a) The final test results shall be... measured on a wet basis. This section is applicable only for measurements made on raw exhaust gas...

40 CFR 89.418 - Raw emission sampling calculations.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 20 2010-07-01 2010-07-01 false Raw emission sampling calculations. 89... Test Procedures § 89.418 Raw emission sampling calculations. (a) The final test results shall be... measured on a wet basis. This section is applicable only for measurements made on raw exhaust gas...

Means and method of sampling flow related variables from a waterway in an accurate manner using a programmable calculator

Treesearch

Rand E. Eads; Mark R. Boolootian; Steven C. [Inventors] Hankin

1987-01-01

Abstract - A programmable calculator is connected to a pumping sampler by an interface circuit board. The calculator has a sediment sampling program stored therein and includes a timer to periodically wake up the calculator. Sediment collection is controlled by a Selection At List Time (SALT) scheme in which the probability of taking a sample is proportional to its...

Obsessive-compulsive disorder and its relationship with disgust vulnerability and conscientiousness.

PubMed

Inchausti, Felix; Delgado, Ana R; Prieto, Gerardo

2015-01-01

The aim of this study was to analyze the relationship between Obsessive-Compulsive Disorder (OCD) symptoms, disgust vulnerability, and the Five Factor Model (FFM) of personality. The sample consisted of 100 adult patients with OCD as a primary diagnosis and 246 with other anxiety disorders (OADs), who responded to OCD, disgust vulnerability, anxiety, depression and personality questionnaires. To perform parametric statistical calculations, all questionnaire scores were transformed from raw ordinal-scale scores to Rasch measures, with interval properties. OCD patients scored significantly higher than OAD patients on DPSS-R Disgust Sensitivity and DPSS-R Disgust Propensity, with a large effect size observed on Disgust Propensity. Furthermore, strong correlations were observed between DPSS-R Propensity to Disgust model scores and DOCS Contamination model scores. Finally, NEO FFI Conscientiousness trait was significantly higher in OCD patients.

Does IGF-1 play a role in the etiopathogenesis of non-functioning adrenocortical adenoma?

PubMed

Bahadir, C T; Ecemis, G C; Atmaca, H

2018-03-14

The aim of this study was to investigate the possible association of insulin-like growth factor-1 (IGF-1) with the pathogenesis of non-functioning adrenocortical adenomas (NFAs). This study included 50 female patients (mean age 54 years) with NFAs, 55 patients (mean age 48 years; 20 male, 35 female) with acromegaly and 38 female control subjects (mean age 58 years). Body mass index (BMI) and waist circumference (WC) of the subjects were recorded and blood samples for IGF-1 were taken. Insulin resistance was calculated using the homeostatic model assessment (HOMA) score. Since most of the acromegaly patients had been using medicine that could have effected insulin resistance, HOMA scores were calculated only in patients with NFAs and the controls. Computerized tomography or magnetic resonance imaging was taken of the acromegalics and controls to detect adrenal mass frequency. The mean age was similar among the groups. As expected, the serum IGF-1 levels were significantly higher in patients with acromegaly than in patients with NFAs and the controls (p < 0.001). Although BMI, WC, and serum IGF-1 levels were significantly higher (p < 0.001) in patients with NFAs, the HOMA scores were similar between patients with NFAs and control groups. Although none of the control subjects had adrenal masses, NFAs were detected in 14 (25%) out of 55 acromegalic patients. Higher serum IGF-1 levels in patients with NFAs compared to the control group and an increased prevalence of NFAs in acromegaly patients compared to control subjects and the general population suggest an association of IGF-1 with the etiopathogenesis of NFA.

Association between the rapid shallow breathing index and extubation success in patients with traumatic brain injury

PubMed Central

dos Reis, Helena França Correia; Almeida, Mônica Lajana Oliveira; da Silva, Mário Ferreira; Moreira, Julião Oliveira; Rocha, Mário de Seixas

2013-01-01

Objective To investigate the association between the rapid shallow breathing index and successful extubation in patients with traumatic brain injury. Methods This study was a prospective study conducted in patients with traumatic brain injury of both genders who underwent mechanical ventilation for at least two days and who passed a spontaneous breathing trial. The minute volume and respiratory rate were measured using a ventilometer, and the data were used to calculate the rapid shallow breathing index (respiratory rate/tidal volume). The dependent variable was the extubation outcome: reintubation after up to 48 hours (extubation failure) or not (extubation success). The independent variable was the rapid shallow breathing index measured after a successful spontaneous breathing trial. Results The sample comprised 119 individuals, including 111 (93.3%) males. The average age of the sample was 35.0±12.9 years old. The average duration of mechanical ventilation was 8.1±3.6 days. A total of 104 (87.4%) participants achieved successful extubation. No association was found between the rapid shallow breathing index and extubation success. Conclusion The rapid shallow breathing index was not associated with successful extubation in patients with traumatic brain injury. PMID:24213084

Cost-effectiveness of Collaborative Care for Depression in Human Immunodeficiency Virus Clinics

PubMed Central

Fortney, John C; Gifford, Allen L; Rimland, David; Monson, Thomas; Rodriguez-Barradas, Maria C.; Pyne, Jeffrey M

2015-01-01

Objective To examine the cost-effectiveness of the HITIDES intervention. Design Randomized controlled effectiveness and implementation trial comparing depression collaborative care with enhanced usual care. Setting Three Veterans Health Administration (VHA) HIV clinics in the Southern US. Subjects 249 HIV-infected patients completed the baseline interview; 123 were randomized to the intervention and 126 to usual care. Intervention HITIDES consisted of an off-site HIV depression care team that delivered up to 12 months of collaborative care. The intervention used a stepped-care model for depression treatment and specific recommendations were based on the Texas Medication Algorithm Project and the VA/Department of Defense Depression Treatment Guidelines. Main outcome measure(s) Quality-adjusted life years (QALYs) were calculated using the 12-Item Short Form Health Survey, the Quality of Well Being Scale, and by converting depression-free days to QALYs. The base case analysis used outpatient, pharmacy, patient, and intervention costs. Cost-effectiveness was calculated using incremental cost effectiveness ratios (ICERs) and net health benefit (NHB). ICER distributions were generated using nonparametric bootstrap with replacement sampling. Results The HITIDES intervention was more effective and cost-saving compared to usual care in 78% of bootstrapped samples. The intervention NHB was positive and therefore deemed cost-effective using an ICER threshold of $50,000/QALY. Conclusions In HIV clinic settings this intervention was more effective and cost-saving compared to usual care. Implementation of off-site depression collaborative care programs in specialty care settings may be a strategy that not only improves outcomes for patients, but also maximizes the efficient use of limited healthcare resources. PMID:26102447

A clinical trial design using the concept of proportional time using the generalized gamma ratio distribution.

PubMed

Phadnis, Milind A; Wetmore, James B; Mayo, Matthew S

2017-11-20

Traditional methods of sample size and power calculations in clinical trials with a time-to-event end point are based on the logrank test (and its variations), Cox proportional hazards (PH) assumption, or comparison of means of 2 exponential distributions. Of these, sample size calculation based on PH assumption is likely the most common and allows adjusting for the effect of one or more covariates. However, when designing a trial, there are situations when the assumption of PH may not be appropriate. Additionally, when it is known that there is a rapid decline in the survival curve for a control group, such as from previously conducted observational studies, a design based on the PH assumption may confer only a minor statistical improvement for the treatment group that is neither clinically nor practically meaningful. For such scenarios, a clinical trial design that focuses on improvement in patient longevity is proposed, based on the concept of proportional time using the generalized gamma ratio distribution. Simulations are conducted to evaluate the performance of the proportional time method and to identify the situations in which such a design will be beneficial as compared to the standard design using a PH assumption, piecewise exponential hazards assumption, and specific cases of a cure rate model. A practical example in which hemorrhagic stroke patients are randomized to 1 of 2 arms in a putative clinical trial demonstrates the usefulness of this approach by drastically reducing the number of patients needed for study enrollment. Copyright © 2017 John Wiley & Sons, Ltd.

Differences in Brain Adaptive Functional Reorganization in Right and Left Total Brachial Plexus Injury Patients.

PubMed

Feng, Jun-Tao; Liu, Han-Qiu; Xu, Jian-Guang; Gu, Yu-Dong; Shen, Yun-Dong

2015-09-01

Total brachial plexus avulsion injury (BPAI) results in the total functional loss of the affected limb and induces extensive brain functional reorganization. However, because the dominant hand is responsible for more cognitive-related tasks, injuries on this side induce more adaptive changes in brain function. In this article, we explored the differences in brain functional reorganization after injuries in unilateral BPAI patients. We applied resting-state functional magnetic resonance imaging scanning to 10 left and 10 right BPAI patients and 20 healthy control subjects. The amplitude of low-frequency fluctuation (ALFF), which is a resting-state index, was calculated for all patients as an indication of the functional activity level of the brain. Two-sample t-tests were performed between left BPAI patients and controls, right BPAI patients and controls, and between left and right BPAI patients. Two-sample t-tests of the ALFF values revealed that right BPAIs induced larger scale brain reorganization than did left BPAIs. Both left and right BPAIs elicited a decreased ALFF value in the right precuneus (P < 0.05, Alphasim corrected). In addition, right BPAI patients exhibited increased ALFF values in a greater number of brain regions than left BPAI patients, including the inferior temporal gyrus, lingual gyrus, calcarine sulcus, and fusiform gyrus. Our results revealed that right BPAIs induced greater extents of brain functional reorganization than left BPAIs, which reflected the relatively more extensive adaptive process that followed injuries of the dominant hand. Copyright © 2015 Elsevier Inc. All rights reserved.

[Identification of an ideal noninvasive method to detect A3243G gene mutation in MELAS syndrome].

PubMed

Ma, Yi-nan; Fang, Fang; Yang, Yan-ling; Zhang, Ying; Wang, Song-tao; Xu, Yu-feng; Pei, Pei; Yuan, Yun; Bu, Ding-fang; Qi, Yu

2008-12-16

To identify a better non-invasive method to detect the carrier of mitochondrial A3243G mutation, a cause of mitochondrial encephalopathy-lactic acidosis-stroke like episode (MELAS) syndrome. DNA was extracted from the peripheral blood, urine, hair follicle, and saliva of 25 MELAS syndrome patients carrying A3243G mutation and their mothers and other maternal relatives, 33 persons in number, and the muscle tissues from 5 patients obtained by biopsy. A3243G mutation was detected by PCR-RFLP method, and the A3243G mutation ratio was identified by measuring the density of each band and calculation with the software AlphaEase 5.0. A3243G mutations were detected in all tissues of the 25 MELAS patients. The A3243G mutation ratio in urine was 62% +/- 9%, significantly higher than that in the blood [(36% +/- 10%), t = -11.13, P < 0.01]. A3243G mutations were detected in at least one tissue of the 28 maternal relatives. The A3243G mutation rates in their urine samples was 33.0% (5.0% - 70.4%), significantly higher than that in their blood samples [8.0% (0 - 33.3%), z = -4.197, P < 0.01]. There was no significant difference in A3243G mutation ratio among the samples of hair follicle, saliva, and blood. The A3243G mutation ratio in urine is significantly higher than those in blood samples of the patients and their maternal relatives. A noninvasive method, A3243G mutation ratio analysis of urine is superior to that in blood.

Using the numerical method in 1836, James Jackson bridged French therapeutic epistemology and American medical pragmatism.

PubMed

Kahn, Linda G; Morabia, Alfredo

2015-04-01

To review James Jackson's analysis of bloodletting among pneumonitis patients at the newly founded Massachusetts General Hospital, in which he implemented the numerical method advocated by Pierre-Charles-Alexandre Louis. The study sample included 34 cases of clinically diagnosed pneumonitis admitted to Massachusetts General Hospital between April 19, 1825, and May 10, 1835, and discharged alive. Patient data were extracted from meticulously kept case books. Jackson calculated mean number of venesections, ounces of blood taken, and days of convalescence within groups stratified by day of the disease when first bloodletting occurred. He also calculated average convalescence within groups stratified by age, sex, prior health, vesication, and day of the disease when the patients were admitted to the hospital. To Jackson's surprise, it "seemed to be of less importance, whether our patients were bled or not, than whether they entered the hospital early or late" after the onset of the pneumonitis. Bloodletting was ineffective. Our multivariate reanalysis of his data confirms his conclusion. Outstandingly for his time, Jackson ruled out unwarranted effects of covariates by tabulating their numerical relations to the duration of pneumonia. Using novel gathering of patient clinical data from hospital records and quantitative analytical methods, Jackson contributed results that challenged conventional wisdom and bridged French therapeutic epistemology and American medical pragmatism. Copyright © 2015 Elsevier Inc. All rights reserved.

Impaired or Not Impaired, That Is the Question: Navigating the Challenges Associated with Using Canadian Normative Data in a Comprehensive Test Battery That Contains American Tests

PubMed Central

Chevalier, Thérèse M.; Stewart, Garth; Nelson, Monty; McInerney, Robert J.; Brodie, Norman

2016-01-01

It has been well documented that IQ scores calculated using Canadian norms are generally 2–5 points lower than those calculated using American norms on the Wechsler IQ scales. However, recent findings have demonstrated that the difference may be significantly larger for individuals with certain demographic characteristics, and this has prompted discussion about the appropriateness of using the Canadian normative system with a clinical population in Canada. This study compared the interpretive effects of applying the American and Canadian normative systems in a clinical sample. We used a multivariate analysis of variance (ANOVA) to calculate differences between IQ and Index scores in a clinical sample, and mixed model ANOVAs to assess the pattern of differences across age and ability level. As expected, Full Scale IQ scores calculated using Canadian norms were systematically lower than those calculated using American norms, but differences were significantly larger for individuals classified as having extremely low or borderline intellectual functioning when compared with those who scored in the average range. Implications of clinically different conclusions for up to 52.8% of patients based on these discrepancies highlight a unique dilemma facing Canadian clinicians, and underscore the need for caution when choosing a normative system with which to interpret WAIS-IV results in the context of a neuropsychological test battery in Canada. Based on these findings, we offer guidelines for best practice for Canadian clinicians when interpreting data from neuropsychological test batteries that include different normative systems, and suggestions to assist with future test development. PMID:27246955

Caution regarding the choice of standard deviations to guide sample size calculations in clinical trials.

PubMed

Chen, Henian; Zhang, Nanhua; Lu, Xiaosun; Chen, Sophie

2013-08-01

The method used to determine choice of standard deviation (SD) is inadequately reported in clinical trials. Underestimations of the population SD may result in underpowered clinical trials. This study demonstrates how using the wrong method to determine population SD can lead to inaccurate sample sizes and underpowered studies, and offers recommendations to maximize the likelihood of achieving adequate statistical power. We review the practice of reporting sample size and its effect on the power of trials published in major journals. Simulated clinical trials were used to compare the effects of different methods of determining SD on power and sample size calculations. Prior to 1996, sample size calculations were reported in just 1%-42% of clinical trials. This proportion increased from 38% to 54% after the initial Consolidated Standards of Reporting Trials (CONSORT) was published in 1996, and from 64% to 95% after the revised CONSORT was published in 2001. Nevertheless, underpowered clinical trials are still common. Our simulated data showed that all minimal and 25th-percentile SDs fell below 44 (the population SD), regardless of sample size (from 5 to 50). For sample sizes 5 and 50, the minimum sample SDs underestimated the population SD by 90.7% and 29.3%, respectively. If only one sample was available, there was less than 50% chance that the actual power equaled or exceeded the planned power of 80% for detecting a median effect size (Cohen's d = 0.5) when using the sample SD to calculate the sample size. The proportions of studies with actual power of at least 80% were about 95%, 90%, 85%, and 80% when we used the larger SD, 80% upper confidence limit (UCL) of SD, 70% UCL of SD, and 60% UCL of SD to calculate the sample size, respectively. When more than one sample was available, the weighted average SD resulted in about 50% of trials being underpowered; the proportion of trials with power of 80% increased from 90% to 100% when the 75th percentile and the maximum SD from 10 samples were used. Greater sample size is needed to achieve a higher proportion of studies having actual power of 80%. This study only addressed sample size calculation for continuous outcome variables. We recommend using the 60% UCL of SD, maximum SD, 80th-percentile SD, and 75th-percentile SD to calculate sample size when 1 or 2 samples, 3 samples, 4-5 samples, and more than 5 samples of data are available, respectively. Using the sample SD or average SD to calculate sample size should be avoided.

The Multitheoretical List of Therapeutic Interventions - 30 items (MULTI-30).

PubMed

Solomonov, Nili; McCarthy, Kevin S; Gorman, Bernard S; Barber, Jacques P

2018-01-16

To develop a brief version of the Multitheoretical List of Therapeutic Interventions (MULTI-60) in order to decrease completion time burden by approximately half, while maintaining content coverage. Study 1 aimed to select 30 items. Study 2 aimed to examine the reliability and internal consistency of the MULTI-30. Study 3 aimed to validate the MULTI-30 and ensure content coverage. In Study 1, the sample included 186 therapist and 255 patient MULTI ratings, and 164 ratings of sessions coded by trained observers. Internal consistency (Chronbach's alpha and McDonald's omega) was calculated and confirmatory factor analysis was conducted. Psychotherapy experts rated content relevance. Study 2 included a sample of 644 patient and 522 therapist ratings, and 793 codings of psychotherapy sessions. In Study 3, the sample included 33 codings of sessions. A series of regression analyses was conducted to examine replication of previously published findings using the MULTI-30. The MULTI-30 was found valid, reliable, and internally consistent across 2564 ratings examined across the three studies presented. The MULTI-30 a brief and reliable process measure. Future studies are required for further validation.

Estimation of Monocrotophos renal elimination half-life in humans.

PubMed

Jose, Arun; Selvakumar, Ratnasamy; Peter, John Victor; Karthik, Gunasekaran; Fleming, Denise Helen; Fleming, Jude Joseph

2015-01-01

Monocrotophos, implicated in about 1/4th of organophosphate poisonings in our centre, is associated with the highest mortality (24%). Yet data on its pharmacokinetics in humans is limited. We estimated the renal elimination half-life of monocrotophos. Consecutive patients presenting with monocrotophos overdose over a 2-month period who had normal renal function were recruited. Monocrotophos in plasma and urine were quantitated by high-performance liquid chromatography. Urine was obtained from catheterised samples at 0-2, 2-4, 4-6, 6-8, 8-12 and 12-24 h. Plasma specimens were collected at the time of admission, and at the midpoint of the urine sample collections at 1, 3, 5, 7, 10, 15 and 21 h. Renal elimination half-life was calculated from the cumulative amount excreted in the urine. The cohort of 5 male patients, aged 35.8 ± 2.94 years, presented with typical organophosphate (cholinergic) toxidrome following intentional monocrotophos overdose. All patients required mechanical ventilation; one patient died. Plasma data was available from 5 patients and urine data from 3 patients. The median renal elimination half-life was 3.3 (range: 1.9-5.0 h). Plasma monocrotophos values, as natural log, fell in a linear fashion up to around 10 h after admission. After the 10-hour period, there was a secondary rise in values in all the 3 patients in whom sampling was continued after 10 h. A renal elimination half-life of 3.3 h for monocrotophos is consistent with a water-soluble compound which is rapidly cleared from the plasma. The secondary rise in plasma monocrotophos values suggests possible re-distribution. Determining the elimination profile of this compound will help develop better strategies for treatment.

Mutational Landscape of cfDNA Identifies Distinct Molecular Features Associated With Therapeutic Response to First-Line Platinum-Based Doublet Chemotherapy in Patients with Advanced NSCLC

PubMed Central

Jiang, Tao; Li, Xuefei; Wang, Jianfei; Su, Chunxia; Han, Wenbo; Zhao, Chao; Wu, Fengying; Gao, Guanghui; Li, Wei; Chen, Xiaoxia; Li, Jiayu; Zhou, Fei; Zhao, Jing; Cai, Weijing; Zhang, Henghui; Du, Bo; Zhang, Jun; Ren, Shengxiang; Zhou, Caicun; Yu, Hui; Hirsch, Fred R.

2017-01-01

Rationale To investigate whether the mutational landscape of circulating cell-free DNA (cfDNA) could predict and dynamically monitor the response to first-line platinum-based chemotherapy in patients with advanced non-small-cell lung cancer (NSCLC). Methods Eligible patients were included and blood samples were collected from a phase III trial. Both cfDNA fragments and fragmented genomic DNA were extracted for enrichment in a 1.15M size panel covering exon regions of 1,086 genes. Molecular mutational burden (MMB) was calculated to investigate the relationship between molecular features of cfDNA and response to chemotherapy. Results In total, 52 eligible cases were enrolled and their blood samples were prospectively collected at baseline, every cycle of chemotherapy and time of disease progression. At baseline, alterations of 17 genes were found. Patients with partial response (PR) had significantly lower baseline MMB of these genes than those patients with either stable disease (SD) (P = 0.0006) or progression disease (PD) (P = 0.0074). Further analysis revealed that the mutational landscape of cfDNA from pretreatment blood samples were distinctly different among patients with PR vs. SD/PD. For patients with baseline TP53 mutation, those with PR experienced a significant reduction in MMB whereas patients with SD or PD experienced an increase after two, three or four cycles of chemotherapy. Furthermore, patients with low MMB had superior response rate and significantly longer progression-free survival than those with high MMB. Conclusion This study indicated that the mutational landscape of cfDNA has potential clinical value to predict the therapeutic response to first-line platinum-based doublet chemotherapy in NSCLC patients. At the single gene level, dynamic change of molecular mutational burden of TP53 is valuable to monitor efficacy (and, therefore, might aid in early recognition of resistance and relapse) in patients harboring this mutation at baseline. PMID:29187901

Use of Therapeutic Drug Monitoring, Electronic Health Record Data, and Pharmacokinetic Modeling to Determine the Therapeutic Index of Phenytoin and Lamotrigine

PubMed Central

Ku, Lawrence C.; Wu, Huali; Greenberg, Rachel G.; Hill, Kevin D.; Gonzalez, Daniel; Hornik, Christoph P.; Berezny, Alysha; Guptill, Jeffrey T.; Jiang, Wenlei; Zheng, Nan; Cohen-Wolkowiez, Michael; Melloni, Chiara

2016-01-01

Background Defining a drug's therapeutic index (TI) is important for patient safety and regulating the development of generic drugs. For many drugs, the TI is unknown. A systematic approach was developed to characterize the TI of a drug using therapeutic drug monitoring and electronic health record (EHR) data with pharmacokinetic (PK) modeling. This approach was first tested on phenytoin, which has a known TI, and then applied to lamotrigine, which lacks a defined TI. Methods Retrospective EHR data from patients in a tertiary hospital were used to develop phenytoin and lamotrigine population PK models and to identify adverse events (anemia, thrombocytopenia, and leukopenia) and efficacy outcomes (seizure-free). Phenytoin and lamotrigine concentrations were simulated for each day with an adverse event or seizure. Relationships between simulated concentrations and adverse events and efficacy outcomes were used to calculate the TI for phenytoin and lamotrigine. Results For phenytoin, 93 patients with 270 total and 174 free concentrations were identified. A de novo 1-compartment PK model with Michaelis-Menten kinetics described the data well. Simulated average total and free concentrations of 10-15 and 1.0-1.5 μg/mL were associated with both adverse events and efficacy in 50% of patients, resulting in a TI of 0.7–1.5. For lamotrigine, 45 patients with 53 concentrations were identified. A published 1-compartment model was adapted to characterize the PK data. No relationships between simulated lamotrigine concentrations and safety or efficacy endpoints were seen; therefore, the TI could not be calculated. Conclusions This approach correctly determined the TI of phenytoin but was unable to determine the TI of lamotrigine due to a limited sample size. The use of therapeutic drug monitoring and EHR data to aid in narrow TI drug classification is promising, but it requires an adequate sample size and accurate characterization of concentration–response relationships. PMID:27764025

Use of Therapeutic Drug Monitoring, Electronic Health Record Data, and Pharmacokinetic Modeling to Determine the Therapeutic Index of Phenytoin and Lamotrigine.

PubMed

Ku, Lawrence C; Wu, Huali; Greenberg, Rachel G; Hill, Kevin D; Gonzalez, Daniel; Hornik, Christoph P; Berezny, Alysha; Guptill, Jeffrey T; Jiang, Wenlei; Zheng, Nan; Cohen-Wolkowiez, Michael; Melloni, Chiara

2016-12-01

Defining a drug's therapeutic index (TI) is important for patient safety and regulating the development of generic drugs. For many drugs, the TI is unknown. A systematic approach was developed to characterize the TI of a drug using therapeutic drug monitoring and electronic health record (EHR) data with pharmacokinetic (PK) modeling. This approach was first tested on phenytoin, which has a known TI, and then applied to lamotrigine, which lacks a defined TI. Retrospective EHR data from patients in a tertiary hospital were used to develop phenytoin and lamotrigine population PK models and to identify adverse events (anemia, thrombocytopenia, and leukopenia) and efficacy outcomes (seizure-free). Phenytoin and lamotrigine concentrations were simulated for each day with an adverse event or seizure. Relationships between simulated concentrations and adverse events and efficacy outcomes were used to calculate the TI for phenytoin and lamotrigine. For phenytoin, 93 patients with 270 total and 174 free concentrations were identified. A de novo 1-compartment PK model with Michaelis-Menten kinetics described the data well. Simulated average total and free concentrations of 10-15 and 1.0-1.5 mcg/mL were associated with both adverse events and efficacy in 50% of patients, resulting in a TI of 0.7-1.5. For lamotrigine, 45 patients with 53 concentrations were identified. A published 1-compartment model was adapted to characterize the PK data. No relationships between simulated lamotrigine concentrations and safety or efficacy endpoints were seen; therefore, the TI could not be calculated. This approach correctly determined the TI of phenytoin but was unable to determine the TI of lamotrigine due to a limited sample size. The use of therapeutic drug monitoring and EHR data to aid in narrow TI drug classification is promising, but it requires an adequate sample size and accurate characterization of concentration-response relationships.

[Opportunity cost for men who visit family medicine units in the city of Querétaro, Mexico].

PubMed

Martínez Carranza, Edith Olimpia; Villarreal Ríos, Enrique; Vargas Daza, Emma Rosa; Galicia Rodríguez, Liliana; Martínez González, Lidia

2010-12-01

To determine the opportunity cost for men who seek care in the family medicine units (FMU) of the Mexican Social Security Institute (IMSS, Instituto Mexicano del Seguro Social) in the city of Querétaro. A sample was selected of 807 men, ages 20 to 59 years, who sought care through the family medicine, laboratory, and pharmacy services provided by the FMU at the IMSS in Querétaro. Patients referred for emergency services and those who left the facilities without receiving care were excluded. The sample (n = 807) was calculated using the averages for an infinite population formula, with a confidence interval of 95% (CI95%) and an average opportunity cost of US$5.5 for family medicine, US$3.1 for laboratory services, and US$2.3 for pharmacy services. Estimates included the amount of time spent on travel, waiting, and receiving care; the number of people accompanying the patient, and the cost per minute of paid and unpaid job activities. The opportunity cost was calculated using the estimated cost per minute for travel, waiting, and receiving care for patients and their companions. The opportunity cost for the patient travel was estimated at US$0.97 (CI95%: 0.81-1.15), while wait time was US$5.03 (CI95%: 4.08-6.09) for family medicine, US$0.06 (CI95%: 0.05-0.08) for pharmacy services, and US$1.89 (CI95%: 1.56-2.25) for laboratory services. The average opportunity cost for an unaccompanied patient visit varied between US$1.10 for pharmacy services alone and US$8.64 for family medicine, pharmacy, and laboratory services. The weighted opportunity cost for family medicine was US$6.24. Given that the opportunity cost for men who seek services in FMU corresponds to more than half of a minimum salary, it should be examined from an institutional perspective whether this is the best alternative for care.

Cardiorespiratory dynamics measured from continuous ECG monitoring improves detection of deterioration in acute care patients: A retrospective cohort study

PubMed Central

Clark, Matthew T.; Calland, James Forrest; Enfield, Kyle B.; Voss, John D.; Lake, Douglas E.; Moorman, J. Randall

2017-01-01

Background Charted vital signs and laboratory results represent intermittent samples of a patient’s dynamic physiologic state and have been used to calculate early warning scores to identify patients at risk of clinical deterioration. We hypothesized that the addition of cardiorespiratory dynamics measured from continuous electrocardiography (ECG) monitoring to intermittently sampled data improves the predictive validity of models trained to detect clinical deterioration prior to intensive care unit (ICU) transfer or unanticipated death. Methods and findings We analyzed 63 patient-years of ECG data from 8,105 acute care patient admissions at a tertiary care academic medical center. We developed models to predict deterioration resulting in ICU transfer or unanticipated death within the next 24 hours using either vital signs, laboratory results, or cardiorespiratory dynamics from continuous ECG monitoring and also evaluated models using all available data sources. We calculated the predictive validity (C-statistic), the net reclassification improvement, and the probability of achieving the difference in likelihood ratio χ2 for the additional degrees of freedom. The primary outcome occurred 755 times in 586 admissions (7%). We analyzed 395 clinical deteriorations with continuous ECG data in the 24 hours prior to an event. Using only continuous ECG measures resulted in a C-statistic of 0.65, similar to models using only laboratory results and vital signs (0.63 and 0.69 respectively). Addition of continuous ECG measures to models using conventional measurements improved the C-statistic by 0.01 and 0.07; a model integrating all data sources had a C-statistic of 0.73 with categorical net reclassification improvement of 0.09 for a change of 1 decile in risk. The difference in likelihood ratio χ2 between integrated models with and without cardiorespiratory dynamics was 2158 (p value: <0.001). Conclusions Cardiorespiratory dynamics from continuous ECG monitoring detect clinical deterioration in acute care patients and improve performance of conventional models that use only laboratory results and vital signs. PMID:28771487

Dried blood spot analysis of an iron chelator--deferasirox and its potential application to therapeutic drug monitoring.

PubMed

Nirogi, Ramakrishna; Ajjala, Devender Reddy; Kandikere, Vishwottam; Aleti, Raghupathi; Srikakolapu, SuryaRao; Vurimindi, Himabindu

2012-10-15

Deferasirox is an iron chelating agent for the treatment of transfusional iron over load in patients with chronic anemia. These anemic patients require close monitoring of the deferasirox exposures for ensuring its therapeutic efficacy. Dried blood spot (DBS) sampling methodology has the advantages of low volume of blood withdrawal and ease of transportation and storage over liquid blood methods. A LC-MS/MS based analytical method was developed using reversed phase column with gradient elution program and quantitated in MRM mode. Linearity range for the liquid blood was 1-1000 ng/mL and for DBS was 5-5000 ng/mL under similar mass spectrometry conditions. The method was validated with respective (M-H)(-) ions, m/z 372→118 for deferasirox and m/z 410→348 for fluvastatin (internal standard). The validated method was applied for the analysis of DBS samples from a rat pharmacokinetic study and results were compared against liquid blood samples from the same animal. The mean C(max) from DBS sample (1121 ng/mL) was comparable to mean C(max) found in blood samples (1015 ng/mL) at 2h after oral dose of deferasirox. All the other calculated pharmacokinetic parameters were quite comparable for both liquid blood and DBS samples. Copyright © 2012. Published by Elsevier B.V.

Optimized keratometry and total corneal astigmatism for toric intraocular lens calculation.

PubMed

Savini, Giacomo; Næser, Kristian; Schiano-Lomoriello, Domenico; Ducoli, Pietro

2017-09-01

To compare keratometric astigmatism (KA) and different modalities of measuring total corneal astigmatism (TCA) for toric intraocular lens (IOL) calculation and optimize corneal measurements to eliminate the residual refractive astigmatism. G.B. Bietti Foundation IRCCS, Rome, Italy. Prospective case series. Patients who had a toric IOL were enrolled. Preoperatively, a Scheimpflug camera (Pentacam HR) was used to measure TCA through ray tracing. Different combinations of measurements at a 3.0 mm diameter, centered on the pupil or the corneal vertex and performed along a ring or within it, were compared. Keratometric astigmatism was measured using the same Scheimpflug camera and a corneal topographer (Keratron). Astigmatism was analyzed with Næser's polar value method. The optimized preoperative corneal astigmatism was back-calculated from the postoperative refractive astigmatism. The study comprised 62 patients (64 eyes). With both devices, KA produced an overcorrection of with-the-rule (WTR) astigmatism by 0.6 diopter (D) and an undercorrection of against-the-rule (ATR) astigmatism by 0.3 D. The lowest meridional error in refractive astigmatism was achieved by the TCA pupil/zone measurement in WTR eyes (0.27 D overcorrection) and the TCA apex/zone measurement in ATR eyes (0.07 D undercorrection). In the whole sample, no measurement allowed more than 43.75% of eyes to yield an absolute error in astigmatism magnitude lower than 0.5 D. Optimized astigmatism values increased the percentage of eyes with this error up to 57.81%, with no difference compared with the Barrett calculator and the Abulafia-Koch calculator. Compared with KA, TCA improved calculations for toric IOLs; however, optimization of corneal astigmatism measurements led to more accurate results. Copyright © 2017 ASCRS and ESCRS. Published by Elsevier Inc. All rights reserved.

Physical fitness reference standards in fibromyalgia: The al-Ándalus project.

PubMed

Álvarez-Gallardo, I C; Carbonell-Baeza, A; Segura-Jiménez, V; Soriano-Maldonado, A; Intemann, T; Aparicio, V A; Estévez-López, F; Camiletti-Moirón, D; Herrador-Colmenero, M; Ruiz, J R; Delgado-Fernández, M; Ortega, F B

2017-11-01

We aimed (1) to report age-specific physical fitness levels in people with fibromyalgia of a representative sample from Andalusia; and (2) to compare the fitness levels of people with fibromyalgia with non-fibromyalgia controls. This cross-sectional study included 468 (21 men) patients with fibromyalgia and 360 (55 men) controls. The fibromyalgia sample was geographically representative from southern Spain. Physical fitness was assessed with the Senior Fitness Test battery plus the handgrip test. We applied the Generalized Additive Model for Location, Scale and Shape to calculate percentile curves for women and fitted mean curves using a linear regression for men. Our results show that people with fibromyalgia reached worse performance in all fitness tests than controls (P < 0.001) in all age ranges (P < 0.001). This study provides a comprehensive description of age-specific physical fitness levels among patients with fibromyalgia and controls in a large sample of patients with fibromyalgia from southern of Spain. Physical fitness levels of people with fibromyalgia from Andalusia are very low in comparison with age-matched healthy controls. This information could be useful to correctly interpret physical fitness assessments and helping health care providers to identify individuals at risk for losing physical independence. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Rilpivirine versus etravirine validity in NNRTI-based treatment failure in Thailand.

PubMed

Teeranaipong, Phairote; Sirivichayakul, Sunee; Mekprasan, Suwanna; Ruxrungtham, Kiat; Putcharoen, Opass

2014-01-01

Etravirine (ETR) and rilpivirine (RPV) are the second-generation non-nucleoside reverse transcriptase inhibitors (NNRTI) for treatment of HIV-1 infection. Etravirine is recommended for patients with virologic failure from first generation NNRTI-based regimen [1]. RPV has profile with similar properties to ETR but this agent is approved for treatment-naïve patients [2]. In Thailand, ETR is approximately 45 times more expensive than RPV. We aimed to study the patterns of genotypic resistance and possibility of using RPV in patients with virologic failure from two common NNRTI-based regimens: efavirenz (EFV)- or nevirapine (NVP)-based regimen. Data of clinical samples with confirmed virologic failure during 2003-2010 were reviewed. We selected the samples from patients who failed EFV- or NVP-based regimen. Resistance-associated mutations (RAMs) were determined by IAS-USA Drug Resistance Mutations. DUET, Monogram scoring system and Stanford Genotypic Resistance Interpretation were applied to determine the susceptibility of ETR and RPV. A total of 2086 samples were analyzed. Samples from 1482 patients with virologic failure from NVP-based regimen treatment failure (NVP group) and 604 patients with virologic failure from EFV-based regimen treatment failure (EFV group) were included. 95% of samples were HIV-1 CRF01_AE subtype. Approximately 80% of samples in each group had one to three NNRTI-RAMs and 20% had four to seven NNRTI-RAMs. 181C mutation was the most common NVP-associated RAM (54.3% vs 14.7%, p<0.01). 103N mutation was the most common EFV-associated RAM (56.5% vs 19.1%, p<0.01). The calculated scores from all three scoring systems were concordant. In NVP group, 165 (11.1%) and 161 (10.9%) patients were susceptible to ETR and RPV, respectively (p=0.81). In EFV group, 195 (32.2%) and 191 (31.6%) patients were susceptible to ETR and RPV, respectively (p=0.81). The proportions of viruses that remained susceptible to ETR and RPV in EFV group were significantly higher than NPV group (ETR susceptibility 32.2% vs 11.1%, p<0.01, RPV susceptibility 31.6% vs 10.9%, p<0.01), respectively. RPV might be a cost saving and reasonable second line NNRTI for patients who failed EFV- or NVP-containing regimens, especially in resource-limited setting because these two agents have comparable susceptibility identified by genotyping. From our study, approximately 30% of patients who failed EFV-based regimens had viruses that remained susceptible to RPV.

40 CFR 600.208-77 - Sample calculation.

Code of Federal Regulations, 2010 CFR

2010-07-01

... ECONOMY AND CARBON-RELATED EXHAUST EMISSIONS OF MOTOR VEHICLES Fuel Economy Regulations for 1977 and Later Model Year Automobiles-Procedures for Calculating Fuel Economy Values § 600.208-77 Sample calculation...

10 CFR Appendix to Part 474 - Sample Petroleum-Equivalent Fuel Economy Calculations

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 3 2010-01-01 2010-01-01 false Sample Petroleum-Equivalent Fuel Economy Calculations Appendix to Part 474 Energy DEPARTMENT OF ENERGY ENERGY CONSERVATION ELECTRIC AND HYBRID VEHICLE RESEARCH, DEVELOPMENT, AND DEMONSTRATION PROGRAM; PETROLEUM-EQUIVALENT FUEL ECONOMY CALCULATION Pt. 474, App. Appendix to Part 474—Sample...

40 CFR 90.419 - Raw emission sampling calculations-gasoline fueled engines.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 20 2011-07-01 2011-07-01 false Raw emission sampling calculations... KILOWATTS Gaseous Exhaust Test Procedures § 90.419 Raw emission sampling calculations—gasoline fueled... selected as the basis for mass emission calculations using the raw gas method. ER03JY95.022 Where: WHC...

40 CFR 90.419 - Raw emission sampling calculations-gasoline fueled engines.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 20 2010-07-01 2010-07-01 false Raw emission sampling calculations... KILOWATTS Gaseous Exhaust Test Procedures § 90.419 Raw emission sampling calculations—gasoline fueled... selected as the basis for mass emission calculations using the raw gas method. ER03JY95.022 Where: WHC...

Quantify patient-specific coronary material property and its impact on stress/strain calculations using in vivo IVUS data and 3D FSI models: a pilot study

PubMed Central

Guo, Xiaoya; Zhu, Jian; Maehara, Akiko; Monoly, David; Samady, Habib; Wang, Liang; Billiar, Kristen L.; Zheng, Jie; Yang, Chun; Mintz, Gary S.; Giddens, Don P.; Tang, Dalin

2016-01-01

Computational models have been used to calculate plaque stress and strain for plaque progression and rupture investigations. An intravascular ultrasound (IVUS)-based modeling approach is proposed to quantify in vivo vessel material properties for more accurate stress/strain calculations. In vivo Cine IVUS and VH-IVUS coronary plaque data were acquired from one patient with informed consent obtained. Cine IVUS data and 3D thin-slice models with axial stretch were used to determine patient-specific vessel material properties. Twenty full 3D fluid–structure interaction models with ex vivo and in vivo material properties and various axial and circumferential shrink combinations were constructed to investigate the material stiffness impact on stress/strain calculations. The approximate circumferential Young’s modulus over stretch ratio interval [1.0, 1.1] for an ex vivo human plaque sample and two slices (S6 and S18) from our IVUS data were 1631, 641, and 346 kPa, respectively. Average lumen stress/strain values from models using ex vivo, S6 and S18 materials with 5 % axial shrink and proper circumferential shrink were 72.76, 81.37, 101.84 kPa and 0.0668, 0.1046, and 0.1489, respectively. The average cap strain values from S18 material models were 150–180 % higher than those from the ex vivo material models. The corresponding percentages for the average cap stress values were 50–75 %. Dropping axial and circumferential shrink consideration led to stress and strain over-estimations. In vivo vessel material properties may be considerably softer than those from ex vivo data. Material stiffness variations may cause 50–75 % stress and 150–180 % strain variations. PMID:27561649

Effect of Reiki therapy on pain and anxiety in adults: an in-depth literature review of randomized trials with effect size calculations.

PubMed

Thrane, Susan; Cohen, Susan M

2014-12-01

The objective of this study was to calculate the effect of Reiki therapy for pain and anxiety in randomized clinical trials. A systematic search of PubMed, ProQuest, Cochrane, PsychInfo, CINAHL, Web of Science, Global Health, and Medline databases was conducted using the search terms pain, anxiety, and Reiki. The Center for Reiki Research also was examined for articles. Studies that used randomization and a control or usual care group, used Reiki therapy in one arm of the study, were published in 2000 or later in peer-reviewed journals in English, and measured pain or anxiety were included. After removing duplicates, 49 articles were examined and 12 articles received full review. Seven studies met the inclusion criteria: four articles studied cancer patients, one examined post-surgical patients, and two analyzed community dwelling older adults. Effect sizes were calculated for all studies using Cohen's d statistic. Effect sizes for within group differences ranged from d = 0.24 for decrease in anxiety in women undergoing breast biopsy to d = 2.08 for decreased pain in community dwelling adults. The between group differences ranged from d = 0.32 for decrease of pain in a Reiki versus rest intervention for cancer patients to d = 4.5 for decrease in pain in community dwelling adults. Although the number of studies is limited, based on the size Cohen's d statistics calculated in this review, there is evidence to suggest that Reiki therapy may be effective for pain and anxiety. Continued research using Reiki therapy with larger sample sizes, consistently randomized groups, and standardized treatment protocols is recommended. Copyright © 2014 American Society for Pain Management Nursing. Published by Elsevier Inc. All rights reserved.

Effect of Reiki Therapy on Pain and Anxiety in Adults: An In-Depth Literature Review of Randomized Trials with Effect Size Calculations

PubMed Central

Thrane, Susan; Cohen, Susan M.

2013-01-01

Objective To calculate the effect of Reiki therapy for pain and anxiety in randomized clinical trials. Data Sources A systematic search of PubMed, ProQuest, Cochrane, PsychInfo, CINAHL, Web of Science, Global Health, and Medline databases was conducted using the search terms pain, anxiety, and Reiki. The Center for Reiki Research was also examined for articles. Study Selection Studies that used randomization and a control or usual care group, used Reiki therapy in one arm of the study, published in 2000 or later in peer-reviewed journals in English, and measured pain or anxiety were included. Results After removing duplicates, 49 articles were examined and 12 articles received full review. Seven studies met the inclusion criteria: four articles studied cancer patients; one examined post-surgical patients; and two analyzed community dwelling older adults. Effect sizes were calculated for all studies using Cohen’s d statistic. Effect sizes for within group differences ranged from d=0.24 for decrease in anxiety in women undergoing breast biopsy to d=2.08 for decreased pain in community dwelling adults. The between group differences ranged from d=0.32 for decrease of pain in a Reiki versus rest intervention for cancer patients to d=4.5 for decrease in pain in community dwelling adults. Conclusions While the number of studies is limited, based on the size Cohen’s d statistics calculated in this review, there is evidence to suggest that Reiki therapy may be effective for pain and anxiety. Continued research using Reiki therapy with larger sample sizes, consistently randomized groups, and standardized treatment protocols is recommended. PMID:24582620

Assessing errors in the determination of base excess.

PubMed

Mentel, Alexander; Bach, Friedhelm; Schüler, Joerg; Herrmann, Walter; Koster, Andreas; Crystal, George J; Gatzounis, Georgios; Mertzlufft, Fritz

2002-05-01

We compared estimates for base excess of extracellular fluid (BE(ecf); mmol/L) obtained in five clinically used blood gas analyzers: AVL Compact 2 (Roche Diagnostics, Mannheim, Germany), Ciba-Corning 860 (Bayer Diagnostics, Fernwald, Germany), IL 1620 (Instrumentation Laboratories, Lexington, MA), Stat Profile Ultra (Nova Biomedical, Waltham, MA), and ABL 510 (Radiometer, Copenhagen, Denmark). A total of 134 measurements per analyzer were obtained in arterial and venous blood samples from 10 patients undergoing cardiac surgery and 65 measurements per analyzer in venous blood samples from 2 healthy volunteers. The blood samples were equilibrated in a tonometer with gases of known composition (37 degrees C). Additional theoretical studies were performed to evaluate the relationship between pH and calculated BE(ecf) value (with varied PCO(2)) using the formulas of the various analyzers. The standard deviations of repeated measurements were 0.24 mmol/L for ABL 510 and approximately 0.45 mmol/L for the other 4 analyzers. The maximal systematic difference between the average of all measurements of each analyzer was 3.7 mmol/L; this was primarily attributable to differences in measuring pH, and, to a lesser extent, to differences in calculation and determination of PCO(2). Comparison of the results from samples with different oxygen saturation showed that the relative alkalinity of deoxygenated hemoglobin (Haldane effect) can also influence the determinations of BE(ecf). A clinically useful way to quantify nonrespiratory disturbances of the acid-base balance is calculation of the base excess of extracellular fluid by using blood gas analyzers. In this study, we found significant variability in estimates of base excess of extracellular fluid obtained with five analyzers from different manufacturers. This variability is attributable to multiple factors, including lack of correction for deoxygenated hemoglobin (Haldane effect).

Clinical Significance of Tissue Factor and CD13 Double-Positive Microparticles in Sirs Patients with Trauma and Severe Sepsis.

PubMed

Matsumoto, Hisatake; Yamakawa, Kazuma; Ogura, Hiroshi; Koh, Taichin; Matsumoto, Naoya; Shimazu, Takeshi

2017-04-01

Activated immune cells such as monocytes are key factors in systemic inflammatory response syndrome (SIRS) following trauma and sepsis. Activated monocytes induce almost all tissue factor (TF) expression contributing to inflammation and coagulation. TF and CD13 double-positive microparticles (TF/CD13MPs) are predominantly released from these activated monocytes. This study aimed to evaluate TF/CD13MPs and assess their usefulness as a biomarker of pathogenesis in early SIRS following trauma and sepsis. This prospective study comprising 24 trauma patients, 25 severe sepsis patients, and 23 healthy controls was conducted from November 2012 to February 2015. Blood samples were collected from patients within 24 h after injury and diagnosis of severe sepsis and from healthy controls. Numbers of TF/CD13MPs were measured by flow cytometry immediately thereafter. Injury Severity Score (ISS) and Acute Physiology and Chronic Health Evaluation (APACHE) II and Sequential Organ Failure Assessment (SOFA) scores were calculated at patient enrollment. APACHE II and SOFA scores and International Society of Thrombosis and Haemostasis (ISTH) overt disseminated intravascular coagulation (DIC) diagnostic criteria algorithm were calculated at the time of enrollment of severe sepsis patients. Numbers of TF/CD13MPs were significantly increased in both trauma and severe sepsis patients versus controls and correlated significantly with ISS and APACHE II score in trauma patients and with APACHE II and ISTH DIC scores in severe sepsis patients. Increased numbers of TF/CD13MPs correlated significantly with severities in the acute phase in trauma and severe sepsis patients, suggesting that TF/CD13MPs are important in the pathogenesis of early SIRS following trauma and sepsis.

Colour Doppler and microbubble contrast agent ultrasonography do not improve cancer detection rate in transrectal systematic prostate biopsy sampling.

PubMed

Taverna, Gianluigi; Morandi, Giovanni; Seveso, Mauro; Giusti, Guido; Benetti, Alessio; Colombo, Piergiuseppe; Minuti, Francesco; Grizzi, Fabio; Graziotti, Pierpaolo

2011-12-01

What's known on the subject? and What does the study add? Transrectal gray-scale ultrasonography guided prostate biopsy sampling is the method for diagnosing prostate cancer (PC) in patients with an increased prostate specific antigen level and/or abnormal digital rectal examination. Several imaging strategies have been proposed to optimize the diagnostic value of biopsy sampling, although at the first biopsy nearly 10-30% of PC still remains undiagnosed. This study compares the PC detection rate when employing Colour Doppler ultransongraphy with or without the injection of SonoVue™ microbubble contrast agent, versus the transrectal ultrasongraphy-guided systematic biopsy sampling. The limited accuracy, sensitivity, specificity and the additional cost of using the contrast agent do not justify its routine application in PC detection. • To compare prostate cancer (PC) detection rate employing colour Doppler ultrasonography with or without SonoVue™ contrast agent with transrectal ultrasonography-guided systematic biopsy sampling. • A total of 300 patients with negative digital rectal examination and transrectal grey-scale ultrasonography, with PSA values ranging between 2.5 and 9.9 ng/mL, were randomized into three groups: 100 patients (group A) underwent transrectal ultrasonography-guided systematic bioptic sampling; 100 patients (group B) underwent colour Doppler ultrasonography, and 100 patients (group C) underwent colour Doppler ultrasonography before and during the injection of SonoVue™. • Contrast-enhanced targeted biopsies were sampled into hypervascularized areas of peripheral, transitional, apical or anterior prostate zones. • All the patients included in Groups B and C underwent a further 13 systematic prostate biopsies. The cancer detection rate was calculated for each group. • In 88 (29.3%) patients a histological diagnosis of PC was made, whereas 22 (7.4%) patients were diagnosed with high-grade prostatic intraepithelial neoplasia or atypical small acinar proliferation. • No significant differences were found among the three groups for cancer detection rate (P= 0.329). • Additionally, low sensitivity, specificity and accuracy of colour Doppler with or without SonoVue™ contrast agent were found. • Prostate cancer detection rate does not significantly improve with the use of colour Doppler ultrasonography with or without SonoVue™. • Although no collateral effects have been highlighted, the combined use of colour Doppler ultrasonography and SonoVue™ determines adjunctive costs and increases the mean time for taking a single prostate biopsy. © 2011 THE AUTHORS. BJU INTERNATIONAL © 2011 BJU INTERNATIONAL.

The Clinical and Economic Burden of Hyperkalemia on Medicare and Commercial Payers

PubMed Central

Fitch, Kathryn; Woolley, J. Michael; Engel, Tyler; Blumen, Helen

2017-01-01

Background Hyperkalemia (serum potassium >5.0 mEq/L) may be caused by reduced kidney function and drugs affecting the renin-angiotensin-aldosterone system and is often present in patients with chronic kidney disease (CKD). Objective To quantify the burden of hyperkalemia in US Medicare fee-for-service and commercially insured populations using real-world claims data, focusing on prevalence, comorbidities, mortality, medical utilization, and cost. Methods A descriptive, retrospective claims data analysis was performed on patients with hyperkalemia using the 2014 Medicare 5% sample and the 2014 Truven Health Analytics MarketScan Commercial Claims and Encounter databases. The starting study samples required patient insurance eligibility during ≥1 months in 2014. The identification of hyperkalemia and other comorbidities required having ≥1 qualifying claims in 2014 with an appropriate International Classification of Diseases, Ninth Revision, Clinical Modification diagnosis code in any position. To address the differences between patients with and without hyperkalemia, CKD subsamples were analyzed separately. Mortality rates were calculated in the Medicare sample population only. The claims were grouped into major service categories; the allowed costs reflected all costs incurred by each cohort divided by the total number of member months for that cohort. Results The prevalence of hyperkalemia in the Medicare and commercially insured samples was 2.3% and 0.09%, respectively. Hyperkalemia was associated with multiple comorbidities, most notably CKD. The prevalence of CKD in the Medicare and the commercially insured members with hyperkalemia was 64.8% and 31.8%, respectively. After adjusting for CKD severity, the annual mortality rate for Medicare patients with CKD and hyperkalemia was 24.9% versus 10.4% in patients with CKD without hyperkalemia. The allowed costs in patients with CKD and hyperkalemia in the Medicare and commercially insured cohorts were more than twice those in patients with CKD without hyperkalemia. Inpatient care accounted for >50% of costs in patients with CKD and hyperkalemia. Conclusion Hyperkalemia is associated with substantial clinical and economic burden among US commercially insured and Medicare populations. PMID:28794824

Routes of transmission during a nosocomial influenza A(H3N2) outbreak among geriatric patients and healthcare workers.

PubMed

Eibach, D; Casalegno, J-S; Bouscambert, M; Bénet, T; Regis, C; Comte, B; Kim, B-A; Vanhems, P; Lina, B

2014-03-01

Influenza presents a life-threatening infection for hospitalized geriatric patients, who might be nosocomially infected via healthcare workers (HCWs), other patients or visitors. In the 2011/2012 influenza season an influenza A(H3N2) outbreak occurred in the geriatric department at the Hôpital Edouard Herriot, Lyon. To clarify the transmission chain for this influenza A(H3N2) outbreak by sequence analysis and to identify preventive measures. Laboratory testing of patients with influenza-like illness in the acute care geriatric department revealed 22 cases of influenza between 19th February and 15th March 2012. Incidences for patients and HCWs were calculated and possible epidemiological links were analysed using a questionnaire. Neuraminidase and haemagglutinin genes of culture-positive samples and community influenza samples were sequenced and clustered to detect patients with identical viral strains. Sixteen patients and six HCWs were affected, resulting in an attack rate of 24% and 11% respectively. Six nosocomial infections were recorded. The sequence analysis confirmed three independent influenza clusters on three different sections of the geriatric ward. For at least two clusters, an HCW source was determined. Epidemiological and microbiological results confirm influenza transmission from HCWs to patients. A higher vaccination rate, isolation measures and better hand hygiene are recommended in order to prevent outbreaks in future influenza seasons. Copyright © 2014 The Healthcare Infection Society. Published by Elsevier Ltd. All rights reserved.

Evaluation of a short dynamic 18F-fluoride PET/CT scanning method to assess bone metabolic activity in spinal orthopedics.

PubMed

Peters, Marloes J M; Wierts, Roel; Jutten, Elisabeth M C; Halders, Servé G E A; Willems, Paul C P H; Brans, Boudewijn

2015-11-01

A complication after spinal fusion surgery is pseudarthrosis, but its radiological diagnosis is of limited value. (18)F-fluoride PET with its ability to assess bone metabolism activity could be of value. The goal of this study was to assess the clinical feasibility of calculating the static standardized uptake value (SUV) from a short dynamic scan without the use of blood sampling, thereby obtaining all dynamic and static parameters in a scan of only 30 min. This approach was tested on a retrospective patient population with persisting pain after spinal fusion surgery. In 16 patients, SUVs (SUV max, SUV mean) and kinetic parameters (K 1, k 2, k 3, v b, K i,NLR, K 1/k 2, k 3/(k 2 + k 3), K i,patlak) were derived from static and dynamic PET/CT scans of operated and control regions of the spine, after intravenous administration of 156-214 MBq (18)F-fluoride. Parameter differences between control and operated regions, as well as between pseudarthrosis and fused segments were evaluated. SUVmean at 30 and 60 min was calculated from kinetic parameters obtained from the dynamic data set (SUV mean,2TCM). Agreement between measured and calculated SUVs was evaluated through Bland-Altman plots. Overall, statistically significant differences between control and operated regions were observed for SUV max, SUV mean, K i,NLR, K i,patlak, K 1/k 2 and k 3/(k 2 + k 3). Diagnostic CT showed pseudarthrosis in 6/16 patients, while in 10/16 patients, segments were fused. Of all parameters, only those regarding the incorporation of bone [K i,NLR, K i,patlak, k 3/(k 2 + k 3)] differed statistically significant in the intervertebral disc space between the pseudarthrosis and fused patients group. The mean values of the patient-specific blood clearance rate [Formula: see text] differed statistically significant between the pseudarthrosis and the fusion group, with a p value of 0.011. This may correspond with the lack of statistical significance of the SUV values between pseudarthrosis and fused patients. Bland-Altman plots show that calculated SUV mean,2TCM values corresponded well with the measured SUV mean values. This study shows the feasibility of a 30-min dynamic (18)F-fluoride PET/CT scanning and this may provide dynamic parameters clinically relevant to the diagnosis of pseudarthrosis.

Hemodialysis delivery, dialysis dose achievement, and vascular access types in hemodialysis patients from the Gulf Cooperation Council countries enrolled in the dialysis outcomes and practice patterns study phase 5 (2012-2015).

PubMed

AlYousef, Anas; AlGhareeb, Sumaya; Al Wakeel, Jamal; Al-Ghamdi, Saeed M G; Bieber, Brian A; Hassan, Mohamad; Al Maimani, Yacoub; Alkandari, Naser; Ahmed, Haroun Z; Fawzy, Ashraf; Pisoni, Ronald L

2016-11-01

The prospective observational Dialysis Outcomes and Practice Patterns Study (DOPPS) was initiated in late 2012 in national samples of hemodialysis (HD) units (n = 41 study sites) in all six Gulf Cooperation Council (GCC) countries (Bahrain, Kuwait, Oman, Qatar, Saudi Arabia, and the United Arab Emirates). For many years, guidelines have recommended single pool Kt/V ≥1.2 as the minimum adequate dose for chronic HD patients. Here, we report initial DOPPS results regarding HD practices related to dialysis dose achievement in the GCC. A total of 928 adult HD patients were included in this analysis from 41 centers representing all six GCC countries. Baseline descriptive statistics (e.g., mean, standard deviation, median, interquartile range, or percentage) were calculated for the study sample. Results were weighted according to the fraction of HD patients sampled within each participating study site. Mean age varied between 51 years in Bahrain, Oman, and Saudi Arabia, 55 years in the United Arab Emirates (UAE) and Kuwait, and 62 years in Qatar. Mean body mass index (BMI) was the lowest in Oman patients (23.9 kg/m 2 , but the remaining GCC countries had mean BMIs of 25.7-28.9 kg/m 2 and substantial fractions of overweight patients. Median dialysis vintage ranged from 1.52 years in Kuwait to 3.52 years in Oman. Mean treatment time per session varied from 202 min in Saudi Arabia to 230 min in Qatar while mean blood flow rate (BFR) ranged between 267 mL/min in Oman and 310 mL/min in Saudi Arabia. Interdialytic weight gain varied considerably among GCC countries between 3.1 and 4.0 kg. Central venous catheter use was high among GCC countries, ranging from 29% in Oman to 56% in Kuwait, with other countries averaging 30-40% catheter use. Data were available only for 50-76% of patients in four GCC countries (Kuwait, Qatar, Saudi Arabia, and UAE) for calculating single pool Kt/V to indicate dialysis adequacy. When calculated for patients with vintage >1 year and dialyzing three times per week, mean single pool Kt/V was highest in Qatar and the UAE (1.50-1.51), intermediate in Kuwait (1.35), and lowest in Saudi Arabia (1.29). A higher risk of mortality was observed for patients having a single pool Kt/V <1.2 (vs. ≥1.2) [hazard ratio (HR) = 1.71, 95% confidence interval [CI]: 1.01-2.92]. Achievement of Kt/V in the GCC, although lower than in other DOPPS regions such as Europe/ANZ and North America, was similar to that in Japan. Japan and the GCC also share the practice of having a lower blood volume filtered per HD session per kg body weight. These findings suggest that increasing mean BFR and treatment time in the GCC, along with reducing catheter use, would substantially increase overall achievement of Kt/V >1.2 in the GCC, and hence, may improve survival. These mortality findings will need to be confirmed with up-coming GCC-DOPPS 6 analysis.

The interaction of fentanyl on the Cp50 of propofol for loss of consciousness and skin incision.

PubMed

Smith, C; McEwan, A I; Jhaveri, R; Wilkinson, M; Goodman, D; Smith, L R; Canada, A T; Glass, P S

1994-10-01

We have previously demonstrated that the minimum alveolar concentration of isoflurane at 1 atm that is required to prevent movement in 50% of patients or animals exposed to a maximal noxious stimulus is markedly reduced by increasing fentanyl concentrations. Total intravenous anesthesia with propofol is increasing in popularity, yet the propofol concentrations required for total intravenous anesthesia or the interaction between propofol and fentanyl have not yet been defined. Propofol and fentanyl were administered via computer-assisted continuous infusion to provide pseudo-steady-state concentrations and allow equilibration between plasma-blood concentration and their biophase concentration. For the induction of anesthesia patients were randomly allocated to receive propofol only or propofol plus fentanyl 0.2, 0.8, 1.5, 3.0, and 4.5 ng/ml. In each group patients were randomized to target propofol concentrations of 1.5-10 micrograms/ml. At 7 and 10 min arterial blood samples were taken for subsequent measurement of propofol and fentanyl concentrations. At 10 min loss of consciousness was assessed by the patients' ability to respond to a simple verbal command. Thereafter a new target concentration of propofol was entered to ensure loss of consciousness, and succinylcholine was administered to facilitate tracheal intubation. Patients were rerandomized to a new target concentration of propofol (1-19 micrograms/ml) until skin incision. Before skin incision and 1 min after skin incision, arterial blood samples were again obtained for subsequent measurement of fentanyl and propofol concentrations. At skin incision and for 1 min the patient was observed for purposeful movement. Only samples in which the pre- and poststimulus drug concentrations were within 35% of each other were included. The propofol blood concentration at which 50% or 95% of patients did not respond to verbal command (Cp50s and Cp95s, respectively) and to skin incision (Cp50i and Cp95i, respectively), were calculated by logistic regression. There were 56 evaluable patients for calculating the propofol Cp50s and 53 patients for calculating the propofol Cp50i. For propofol alone the Cp50s was 3.3 micrograms/ml and the Cp95s 5.4 microgram/ml. Increasing fentanyl concentrations reduced the Cp50s (P = 0.03), and increasing age decreased the Cp50s (P = 0.04). For propofol alone the Cp50i was 15.2 (95% confidence interval 7.6-22.8) micrograms/ml and the Cp95i 27.4 micrograms/ml. Increasing fentanyl concentrations markedly reduced the Cp50i (P < 0.01), with a 50% reduction in Cp50i produced by 0.63 ng/ml fentanyl. The propofol Cp50i was decreased by 63% with 1 ng/ml fentanyl and 89% by 3 ng/ml fentanyl. At higher fentanyl concentrations the decrease in Cp50i was proportionally less, demonstrating a ceiling effect. We defined the propofol concentration required for loss of consciousness and showed that it is reduced by increasing fentanyl concentration and by increasing age. The propofol concentration (alone) adequate for skin incision is high but is markedly reduced by fentanyl. A ceiling effect in the Cp50i for propofol is seen with fentanyl concentrations greater than 3 ng/ml.

Effect of a training programme on blood culture contamination rate in critical care.

PubMed

Sánchez-Sánchez, M M; Arias-Rivera, S; Fraile-Gamo, P; Jareño-Collado, R; López-Román, S; Vadillo-Obesso, P; García-González, S; Pulido-Martos, M T; Sánchez-Muñoz, E I; Cacho-Calvo, J; Martín-Pellicer, A; Panadero-Del Olmo, L; Frutos-Vivar, F

2018-03-30

Blood culture contamination can occur from extraction to processing; its rate should not exceed 3%. To evaluate the impact of a training programme on the rate of contaminated blood cultures after the implementation of sample extraction recommendations based on the best evidence. Prospective before-after study in a polyvalent intensive care unit with 18 beds. Two phases were established (January-June 2012, October 2012-October 2015) with a training period between them. Main recommendations: sterile technique, surgical mask, double skin disinfection (70° alcohol and 2% alcoholic chlorhexidine), 70° alcohol disinfection of culture flasks and injection of samples without changing needles. Including all blood cultures of patients with extraction request. demographic, severity, pathology, reason for admission, stay and results of blood cultures (negative, positive and contaminated). Basic descriptive statistics: mean (standard deviation), median (interquartile range) and percentage (95% confidence interval). Calculated contamination rates per 100 blood cultures extracted. Bivariate analysis between periods. Four hundred and eight patients were included. Eight hundred and forty-one blood cultures were taken, 33 of which were contaminated. In the demographic variables, severity, diagnosis and stay of patients with contaminated samples, no differences were observed from those with uncontaminated samples. Pre-training vs post-training contamination rates: 14 vs 5.6 per 100 blood cultures extracted (P=.00003). An evidence-based training programme reduced the contamination of samples. It is necessary to continue working on the planning of activities and care to improve the detection of pollutants and prevent contamination of samples. Copyright © 2018 Sociedad Española de Enfermería Intensiva y Unidades Coronarias (SEEIUC). Publicado por Elsevier España, S.L.U. All rights reserved.

Reduced Appendicular Lean Body Mass, Muscle Strength, and Size of Type II Muscle Fibers in Patients with Spondyloarthritis versus Healthy Controls: A Cross-Sectional Study.

PubMed

Røren Nordén, Kristine; Dagfinrud, Hanne; Løvstad, Amund; Raastad, Truls

Introduction . The purpose of this study was to investigate body composition, muscle function, and muscle morphology in patients with spondyloarthritis (SpA). Methods . Ten male SpA patients (mean ± SD age 39 ± 4.1 years) were compared with ten healthy controls matched for sex, age, body mass index, and self-reported level of physical exercise. Body composition was measured by dual energy X-ray absorptiometry. Musculus quadriceps femoris (QF) strength was assessed by maximal isometric contractions prior to test of muscular endurance. Magnetic resonance imaging of QF was used to measure muscle size and calculate specific muscle strength. Percutaneous needle biopsy samples were taken from m. vastus lateralis . Results . SpA patients presented with significantly lower appendicular lean body mass (LBM) ( p = 0.02), but there was no difference in bone mineral density, fat mass, or total LBM. Absolute QF strength was significantly lower in SpA patients ( p = 0.03) with a parallel trend for specific strength ( p = 0.08). Biopsy samples from the SpA patients revealed significantly smaller cross-sectional area (CSA) of type II muscle fibers ( p = 0.04), but no difference in CSA type I fibers. Conclusions . Results indicate that the presence of SpA disease is associated with reduced appendicular LBM, muscle strength, and type II fiber CSA.

Adolescent chronic fatigue syndrome: prevalence, incidence, and morbidity.

PubMed

Nijhof, Sanne L; Maijer, Kimberley; Bleijenberg, Gijs; Uiterwaal, Cuno S P M; Kimpen, Jan L L; van de Putte, Elise M

2011-05-01

To determine nationwide general practitioner (GP)-diagnosed prevalence and pediatrician-diagnosed incidence rates of adolescent chronic fatigue syndrome (CFS), and to assess CFS morbidity. We collected data from a cross-sectional national sample among GPs and prospective registration of new patients with CFS in all pediatric hospital departments in the Netherlands. Study participants were adolescents aged 10 to 18 years. A representative sample of GPs completed questionnaires on the prevalence of CFS in their adolescent patients. Pediatric hospital departments prospectively reported new cases of CFS in adolescent patients. For every new reported case, a questionnaire was sent to the reporting pediatrician and the reported patient to assess CFS morbidity. Prevalence was estimated through the data from GP questionnaires and incidence was estimated on the basis of cases newly reported by pediatricians from January to December 2008. Prevalence was calculated as 111 per 100 000 adolescents and incidence as 12 per 100 000 adolescents per year. Of newly reported patients with CFS, 91% scored at or above cutoff points for severe fatigue and 93% at or above the cutoff points for physical impairment. Forty-five percent of patients with CFS reported >50% school absence during the previous 6 months. Clinically diagnosed incidence and prevalence rates show that adolescent CFS is uncommon compared with chronic fatigue. The primary adverse impact of CFS is extreme disability associated with considerable school absence.

40 CFR Appendix II to Part 600 - Sample Fuel Economy Calculations

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 29 2010-07-01 2010-07-01 false Sample Fuel Economy Calculations II Appendix II to Part 600 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) ENERGY POLICY FUEL ECONOMY AND CARBON-RELATED EXHAUST EMISSIONS OF MOTOR VEHICLES Pt. 600, App. II Appendix II to Part 600—Sample Fuel Economy Calculations (...

7 CFR 51.308 - Methods of sampling and calculation of percentages.

Code of Federal Regulations, 2013 CFR

2013-01-01

... Grades of Apples Methods of Sampling and Calculation of Percentages § 51.308 Methods of sampling and... weigh ten pounds or less, or in any container where the minimum diameter of the smallest apple does not vary more than 1/2 inch from the minimum diameter of the largest apple, percentages shall be calculated...

7 CFR 51.308 - Methods of sampling and calculation of percentages.

Code of Federal Regulations, 2014 CFR

2014-01-01

... Grades of Apples Methods of Sampling and Calculation of Percentages § 51.308 Methods of sampling and... weigh ten pounds or less, or in any container where the minimum diameter of the smallest apple does not vary more than 1/2 inch from the minimum diameter of the largest apple, percentages shall be calculated...

In vivo evaluation of DIAGNOdent for the quantification of occlusal dental caries.

PubMed

Khalife, Moufida A; Boynton, James R; Dennison, Joseph B; Yaman, Peter; Hamilton, James C

2009-01-01

The accurate diagnosis of non-cavitated occlusal caries is generally considered problematic. Induced fluorescence quantified by the DIAGNOdent device (KaVo) gives a reading from 0-99, which may help in the caries diagnostic process. There is some controversy around the implication of increased severity of decay with increased DIAGNOdent readings. This in vivo study assessed the correlation of depth and volume of decay as it was removed by traditional rotary handpieces with DIAGNOdent readings and determined sensitivities/specificities of the device at different cut-off points. Included in the current study were 31 patients providing 60 permanent molar and premolar occlusal surfaces suspected of dentinal decay. DIAGNOdent readings were recorded, along with lesion depth (as measured by periodontal probe) and volume measurements (as calculated from measuring the mass of a polyvinyl siloxane impression of the cavity, divided by the material's calculated density). Clinical detection of decay at the DEJ was used as the gold-standard to calculate an appropriate cut-off. Pearson correlation coefficients indicated that DIAGNOdent readings were weakly correlated with lesion depth (r = 0.47) and lesion volume (also r = 0.47). An appropriate cut-off point for the sample in the current study was calculated between 35 and 40; a more specific cut-off point could not be determined due to the sample size distribution. It was concluded that the DIAGNOdent device should be used as an adjunct in the caries diagnosis and treatment planning process.

Classification of the severe trauma patient with the Abbreviated Injury Scale: degree of correlation between versions 98 and 2005 (2008 update).

PubMed

Abajas Bustillo, Rebeca; Leal Costa, César; Ortego Mate, María Del Carmen; Zonfrillo, Mark R; Seguí Gómez, María; Durá Ros, María Jesús

2018-02-01

To explore differences in severity classifications according to 2 versions of the Abbreviated Injury Scale (AIS): version 2005 (the 2008 update) and the earlier version 98. To determine whether possible differences might have an impact on identifying severe trauma patients. Descriptive study and cross-sectional analysis of a case series of patients admitted to two spanish hospitals with out-of-hospital injuries between February 2012 and February 2013. For each patient we calculated the Injury Severity Score (ISS), the New Injury Severity Score (NISS), and the AIS scores according to versions 98 and 2005. The sample included 699 cases. The mean Severity (SD) age of patients was 52.7 (29.2) years, and 388 (55.5%) were males. Version 98 of the AIS correlated more strongly with both the ISS (2.6%) and the NISS (2.9%). The 2008 update of the AIS (version 2005) classified fewer trauma patients than version 98 at the severity levels indicated by the ISS and NISS.

Abundance of Enterobacteriaceae in the colon mucosa in diverticular disease.

PubMed

Linninge, Caroline; Roth, Bodil; Erlanson-Albertsson, Charlotte; Molin, Göran; Toth, Ervin; Ohlsson, Bodil

2018-02-15

To compare gut bacterial diversity and amount of Enterobacteriaceae in colonic mucosa between patients with and without diverticular disease (DD). Patients in a stable clinical condition with planned elective colonoscopy were included. Blood samples and colon mucosa biopsies were collected at the colonoscopy. Study questionnaires including questions about gastrointestinal symptoms were completed by the patients and physicians. DNA from mucosa samples was isolated and the amount of Enterobacteriaceae was estimated using PCR assay. Terminal restriction fragment length polymorphism was applied to assess microbial diversity. Diversity was estimated by calculations of richness (number of terminal restriction fragments) and Shannon-Wiener and Simpson's indices. A total of 51 patients were included, 16 patients with DD [68 (62-76) years] and 35 controls [62 (40-74) years] without any diverticula. Patients with DD had significantly higher levels of Enterobacteriaceae than those without DD ( P = 0.043), and there was an inverse relationship between the amount of Enterobacteriaceae and the Simpson's index (rs = -0.361, P = 0.033) and the Shannon-Wiener index (rs = -0.299, P = 0.081). The Simpson's index ( P = 0.383), Shannon-Wiener index ( P = 0.401) or number of restrictions fragments ( P = 0.776) did not differ between DD and controls. The majority of patients experienced gastrointestinal symptoms, and 22 patients (43.1%) fulfilled the criteria for irritable bowel syndrome, with no difference between the groups ( P = 0.212). Demography, socioeconomic status, lifestyle habits, inflammatory biomarkers, or symptoms were not related to the amount of Enterobacteriaceae or bacterial diversity. Patients with DD had higher amount of Enterobacteriaceae in the colon mucosa compared to patients without diverticula.

[Epidemiological study on urinary stones in the region of Fez and the risk of recurrence].

PubMed

El Habbani, R; Chaqroune, A; Sqalli Houssaini, T; Arrayhani, M; El Ammari, J; Dami, F; Chouhani, B A; Lahrichi, A

2016-04-01

In Morocco, few works on morpho-constitutional analysis of urinary calculi have been published, especially for patients in the region of Fez. This work aims to make a retrospective epidemiological study on the nature of urinary calculi with patients from the region of Fez and control the urine of the same patients after a period of three months to report on the risk of recurrence. Urinary stones were collected mostly in the nephrology service and urology service at the Hassan II Hospital in Fez. These calculations after being dried for 24 hours at room temperature underwent a morphological analysis, followed by infrared spectroscopic analysis Fourier transform. After a period of about three months, morning urine of the same patients was analyzed by crystalluria to control the presence of crystals that reflect a risk of recurrence. In our series of 123 samples, the age of patients ranges from 2-79 years. The prevalence was higher for men with a sex ratio of 1.3. The results of the analysis calculations showed that 61% were formed of calcium oxalate and 15% of uric acid and 25% of stones were carbapatite, struvite, cystine… The study by crystalluria urine revealed the presence of the crystals in 69% of patients' nephrolithiasis. The results of our study are conformed to the series of results in other regions of Morocco regarding the predominance of calcium oxalate stones. The presence of crystals in the urine of 69% of patients may indicate other recurrences. 4. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

Effect of Education of Principles of Drug Prescription and Calculation through Lecture and Designed Multimedia Software on Nursing Students' Learning Outcomes.

PubMed

Valizadeh, Sousan; Feizalahzadeh, Hossein; Avari, Mina; Virani, Faza

2016-07-01

Medication errors are risk factors for patients' health and may have irrecoverable effects. These errors include medication miscalculations by nurses and nursing students. This study aimed to design a multimedia application in the field of education for drug calculations in order to compare its effectiveness with the lecture method. This study selected 82 nursing students of Tabriz University of Medical Sciences in their second and third semesters in 2015. They were pre-tested by a researcher-made multiple-choice questionnaire on their knowledge of drug administration principles and ability to carry out medicinal calculations before training and were then divided through a random block design into two groups of intervention (education with designed software) and control (lecturing) based on the mean grade of previous semesters and the pre-test score. The knowledge and ability post-test was performed using the same questions after 4 weeks of training, and the data were analyzed with IBM SPSS 20 using independent samples t-test, paired-samples t-test, and ANCOVA. Drug calculation ability significantly increased after training in both the control and experimental groups (p<0.05). However, no significant difference emerged between the two groups in terms of medicinal calculation ability after training (p>0.05). The results showed that both training methods had no significant effect on study participants' knowledge of medicinal principles (p>0.05), whereas the score of knowledge of medicinal principles in the control group increased non-significantly. The results of the Kolmogorov-Smirnov test show that, since p>0.05, the data in the variable of knowledge of drug prescription principles and ability of medicinal calculations had a normal distribution. The use of educational software has no significant effect on nursing students' drug knowledge or medicinal calculation ability. However, an e-learning program can reduce the lecture time and cost of repeated topics, such as medication, suggesting that it can be an effective component in nurse education programs.

SPECT myocardial perfusion imaging as an adjunct to coronary calcium score for the detection of hemodynamically significant coronary artery stenosis

PubMed Central

2012-01-01

Background Coronary artery calcifications (CAC) are markers of coronary atherosclerosis, but do not correlate well with stenosis severity. This study intended to evaluate clinical situations where a combined approach of coronary calcium scoring (CS) and nuclear stress test (SPECT-MPI) is useful for the detection of relevant CAD. Methods Patients with clinical indication for invasive coronary angiography (ICA) were included into our study during 08/2005-09/2008. At first all patients underwent CS procedure as part of the study protocol performed by either using a multidetector computed tomography (CT) scanner or a dual-source CT imager. CAC were automatically defined by dedicated software and the Agatston score was semi-automatically calculated. A stress-rest SPECT-MPI study was performed afterwards and scintigraphic images were evaluated quantitatively. Then all patients underwent ICA. Thereby significant CAD was defined as luminal stenosis ≥75% in quantitative coronary analysis (QCA) in ≥1 epicardial vessel. To compare data lacking Gaussian distribution an unpaired Wilcoxon-Test (Mann–Whitney) was used. Otherwise a Students t-test for unpaired samples was applied. Calculations were considered to be significant at a p-value of <0.05. Results We consecutively included 351 symptomatic patients (mean age: 61.2±12.3 years; range: 18–94 years; male: n=240) with a mean Agatston score of 258.5±512.2 (range: 0–4214). ICA verified exclusion of significant CAD in 66/67 (98.5%) patients without CAC. CAC was detected in remaining 284 patients. In 132/284 patients (46.5%) with CS>0 significant CAD was confirmed by ICA, and excluded in 152/284 (53.5%) patients. Sensitivity for CAD detection by CS alone was calculated as 99.2%, specificity was 30.3%, and negative predictive value was 98.5%. An additional SPECT in patients with CS>0 increased specificity to 80.9% while reducing sensitivity to 87.9%. Diagnostic accuracy was 84.2%. Conclusions In patients without CS=0 significant CAD can be excluded with a high negative predictive value by CS alone. An additional SPECT-MPI in those patients with CS>0 leads to a high diagnostic accuracy for the detection of CAD while reducing the number of patients needing invasive diagnostic procedure. PMID:23206557

Sample size calculation for a proof of concept study.

PubMed

Yin, Yin

2002-05-01

Sample size calculation is vital for a confirmatory clinical trial since the regulatory agencies require the probability of making Type I error to be significantly small, usually less than 0.05 or 0.025. However, the importance of the sample size calculation for studies conducted by a pharmaceutical company for internal decision making, e.g., a proof of concept (PoC) study, has not received enough attention. This article introduces a Bayesian method that identifies the information required for planning a PoC and the process of sample size calculation. The results will be presented in terms of the relationships between the regulatory requirements, the probability of reaching the regulatory requirements, the goalpost for PoC, and the sample size used for PoC.

A microbiological method for determining serum levels of broad spectrum β-lactam antibiotics in critically ill patients.

PubMed

Fridlund, Jimmy; Woksepp, Hanna; Schön, Thomas

2016-10-01

Recent studies show that suboptimal blood levels of β-lactam antibiotics are present in intensive care unit (ICU) patients. A common reference method for assessing drug concentrations is liquid chromatography coupled with mass-spectrometry (LC-MS) which is highly accurate but rarely available outside reference centres. Thus, our aim was to develop a microbiological method for monitoring β-lactam antibiotic serum levels which could be used at any hospital with a microbiological laboratory. The method was developed as a 96-well broth microdilution format to assess the concentrations of cefotaxime (CTX), meropenem (MER), and piperacillin (PIP). Patient serum containing antibiotics were diluted in suspensions of bacteria with known minimal inhibitory concentrations (MICs). Serum antibiotic concentrations were calculated by dividing the MIC with the dilution factor at which the serum inhibited growth of the bacterial suspension. Serum (n=88) from ICU patients at four hospitals in south-east Sweden were analysed and compared to LC-MS analysis. The overall accuracy and precision for spiked samples and patient samples was within the pre-set target of ±20.0% for all drugs. There was a significant correlation between the microbiological assay and LC-MS for the patient samples (CTX: r=0.86, n=31; MER: r=0.96, n=11; PIP: r=0.88, n=39) and the agreement around the clinical cut-off for CTX (4.0mg/l), MER (2.0mg/l) and PIP (16.0mg/l) was 90%, 100% and 87%, respectively. The microbiological method has a performance for determination of serum levels of meropenem, piperacillin and cefotaxime suitable for clinical use. It is an inexpensive method applicable in any microbiology laboratory. Copyright © 2016 Elsevier B.V. All rights reserved.

WHO/INRUD patient care and facility-specific drug use indicators at primary health care centres in Eastern province, Saudi Arabia.

PubMed

El Mahalli, A A; Akl, O A M; Al-Dawood, S F; Al-Nehab, A A; Al-Kubaish, H A; Al-Saeed, S; Elkahky, A A A; Salem, A M A A

2012-11-01

This study aimed to measure the performance of primary health care centres in Eastern province, Saudi Arabia, using the WHO/International Network of Rational Use of Drugs patient care and facility-specific drug use indicators. In a cross-sectional study, 10 health centres were selected using systematic random sampling. A total of 300 patients were interviewed while visiting the centre from January to March 2011 and 10 pharmacists from the same centres were interviewed. Average consultation time was 7.3 min (optimal > or = 30 min), percentage of drugs adequately labelled was 10% (optimal 100%) and patient's knowledge of correct dosage was 79.3% (optimal 100%). The percentage of key drugs in stock was only 59.2% (optimal 100%). An overall index of rational facility-specific drug use was calculated and applied to rank the health centres for benchmarking.

The Influence of Procedure Delay on Resource Utilization: A National Study of Patients with Open Tibial Fracture

PubMed Central

Sears, Erika Davis; Burke, James F.; Davis, Matthew M.; Chung, Kevin C.

2016-01-01

Background The purpose of this study is to 1) understand national variation in delay of emergency procedures in patients with open tibial fracture at the hospital level and 2) compare length of stay (LOS) and cost in patients cared for at the best and worst performing hospitals for delay. Methods We retrospectively analyzed the 2003 – 2009 Nationwide Inpatient Sample. Adult patients with primary diagnosis of open tibial fracture were selected for inclusion. We calculated hospital probability of delay of emergency procedures beyond the day of admission (day 0). Multilevel linear regression random effects models were created to evaluate the relationship between the treating hospital’s tendency for delay (in quartiles) and the log-transformed outcomes of LOS and cost, while adjusting for patient and hospital variables. Results The final sample included 7,029 patients from 332 hospitals. Adjusted analyses demonstrate that patients treated at hospitals in the fourth (worst) quartile for delay were estimated to have 12% (95% CI 2–21%) higher cost compared to patients treated at hospitals in the first quartile. In addition, patients treated at hospitals in the fourth quartile had an estimated 11% (CI 4–17%) longer LOS compared to patients treated at hospitals in the first quartile. Conclusions Patients with open tibial fracture treated at hospitals with more timely initiation of surgical care had lower cost and shorter LOS than patients treated at hospitals with less timely initiation of care. Policies directed toward mitigating variation in care are not only beneficial for patient outcomes, but may also reduce unnecessary waste. Level II (Prognostic) PMID:23142940

Quality of Life in Patients With Primary and Metastatic Brain Tumors in the Literature as Assessed by the FACT-Br.

PubMed

Chiu, Nicholas; Chiu, Leonard; Zeng, Liang; Zhang, Liying; Cella, David; Popovic, Marko; Chow, Ronald; Lam, Henry; Poon, Michael; Chow, Edward

2012-12-01

The Functional Assessment of Cancer Therapy-Brain (FACT-Br) is a quality of life (QOL) assessment tool that was originally developed for use in patients with primary brain tumors. However, the tool has also been used to assess QOL in patients with metastatic brain tumors. The purpose of this study is to compare the differences in QOL responses as assessed by the FACT-Br in patients with primary and metastatic brain neoplasms. A systematic literature search was conducted using the OvidSP platform in MEDLINE (1946 to July Week 2 2012) and EMBASE (1980 to 2012 Week 28). Articles in which the FACT-Br was used as a QOL assessment for patients with malignant brain tumors (both primary and metastatic) were included in the study. The weighted means of FACT-Br subscale and overall scores were calculated for the studies. To compare these scores, weighted analysis of variance was conducted and PROC GLM was performed for the data. A P-value of < 0.05 was considered statistically significant. A total of 23 studies (four in brain metastases, 18 in primary brain tumors and 1 in a mixed sample) using the FACT-Br for assessment of QOL were identified. Social and functional well-being were significantly better in patients with primary brain tumors (weighted mean score of 22.2 vs. 10.7, P = 0.0026, 16.9 vs. 6.2, P = 0.0025, respectively). No other scale of the FACT-Br was significantly different between the two groups and the performance status of patients included in both groups was similar. Patients with primary brain cancer seemed to have better social and functional well-being scores than those with metastatic brain tumors. Other QOL domains were similar between these two groups. However, the heterogeneity in the included studies and the low sample size of included samples in patients with metastatic brain tumors could have confounded our findings.

[Estimation of the risk of upper digestive tract bleeding in patients with portal cavernomatosis].

PubMed

Couselo, M; Ibáñez, V; Mangas, L; Gómez-Chacón, J; Vila Carbó, J J

2011-01-01

The aim of this study is to find out the risk of upper gastrointestinal bleeding (UGB) after the diagnosis of portal cavernoma in children, and to investigate several potential risk factors. We analyzed retrospectively 13 cases of portal cavernoma and estimated the risk of UGB with the Kaplan-Meier survival analysis. We calculated the incidence rate of the sample and the number of haemorrhages per year for each patient individually. From the moment of the diagnosis various parameters were recorded: age, platelets, leukocytes, hemoblobin, hematocrit, prothrombin time and number of bleedings. The relation between these parameters and the risk of bleeding was assessed with the Cox analysis. The patients were followed for a median period of 7.1 years. 10 patients (77%) presented at least 1 episode of UGB after the diagnosis. The median survival time until the first haemorrhage was 314 days. After the diagnosis the incidence rate of the sample was 0.43 episodes of upper gastrointestinal bleeding per person-year. The number of individual bleedings per person had a range of 0-2.2 episodes per year. There is very few data about the risk of bleeding in children with portal cavernoma. In our sample, we found out an incidence rate of 0.43 and a median survival time of 314 days until the first episode of bleeding after the diagnosis, but we were not able to find a statistically significant association between the studied variables and the risk of bleeding.

Maturation of the Middle Phalanx of the Third Finger: A Comparative Study between Right and Left Hand.

PubMed

Gracco, Antonio; Bruno, Giovanni; De Stefani, Alberto; Siviero, Laura; Perri, Alessandro; Stellini, Edoardo

Recently a classification of patient's skeletal age based on the phalanx maturation, The Middle Phalanx Maturation of the third finger (MPM) method, was suggested. The aim of this study is to evaluate if there is a difference in MPM between the right and left hand. Two hundred fifty-four patients were obtained from the Complex Operating Unit of Orthodontics of Padua University Hospital. The total sample size has been selected by appropriate statistical calculations resulting in 130 patients. It was decided to further double the sample size of a previous study to ensure a robust statistical analysis. Radiographs of the right and left were obtained using the MPM method. Stages were compared using the right hand as a reference. The statistical analysis (Fisher exact test) was performed for the entire sample and related to gender in order to compare the right and the left hand stages. In MPS2, 6 out 49 (12.2%) males and 7 out 27 females (25.9%) showed MPS3 in the left hand (p-value < 0.05). In all other stages, a total agreement (100%) was found. The authors confirm the use of the right hand as reference. In patients with MPS2 an additional radiograph on the left hand can be taken in order to increase the diagnostic accuracy. In all other stages other radiographs are not needed as a total agreement between the right and left hand was found.

Variation between Hospitals with Regard to Diagnostic Practice, Coding Accuracy, and Case-Mix. A Retrospective Validation Study of Administrative Data versus Medical Records for Estimating 30-Day Mortality after Hip Fracture.

PubMed

Helgeland, Jon; Kristoffersen, Doris Tove; Skyrud, Katrine Damgaard; Lindman, Anja Schou

2016-01-01

The purpose of this study was to assess the validity of patient administrative data (PAS) for calculating 30-day mortality after hip fracture as a quality indicator, by a retrospective study of medical records. We used PAS data from all Norwegian hospitals (2005-2009), merged with vital status from the National Registry, to calculate 30-day case-mix adjusted mortality for each hospital (n = 51). We used stratified sampling to establish a representative sample of both hospitals and cases. The hospitals were stratified according to high, low and medium mortality of which 4, 3, and 5 hospitals were sampled, respectively. Within hospitals, cases were sampled stratified according to year of admission, age, length of stay, and vital 30-day status (alive/dead). The final study sample included 1043 cases from 11 hospitals. Clinical information was abstracted from the medical records. Diagnostic and clinical information from the medical records and PAS were used to define definite and probable hip fracture. We used logistic regression analysis in order to estimate systematic between-hospital variation in unmeasured confounding. Finally, to study the consequences of unmeasured confounding for identifying mortality outlier hospitals, a sensitivity analysis was performed. The estimated overall positive predictive value was 95.9% for definite and 99.7% for definite or probable hip fracture, with no statistically significant differences between hospitals. The standard deviation of the additional, systematic hospital bias in mortality estimates was 0.044 on the logistic scale. The effect of unmeasured confounding on outlier detection was small to moderate, noticeable only for large hospital volumes. This study showed that PAS data are adequate for identifying cases of hip fracture, and the effect of unmeasured case mix variation was small. In conclusion, PAS data are adequate for calculating 30-day mortality after hip-fracture as a quality indicator in Norway.

45 CFR Appendix C to Part 1356 - Calculating Sample Size for NYTD Follow-Up Populations

Code of Federal Regulations, 2013 CFR

2013-10-01

... 45 Public Welfare 4 2013-10-01 2013-10-01 false Calculating Sample Size for NYTD Follow-Up Populations C Appendix C to Part 1356 Public Welfare Regulations Relating to Public Welfare (Continued) OFFICE... REQUIREMENTS APPLICABLE TO TITLE IV-E Pt. 1356, App. C Appendix C to Part 1356—Calculating Sample Size for NYTD...

Association of Epsilon-Aminocaproic Acid With Blood Loss and Risk of Transfusion After Periacetabular Osteotomy: A Retrospective Cohort Study.

PubMed

McLawhorn, Alexander S; Levack, Ashley E; Fields, Kara G; Sheha, Evan D; DelPizzo, Kathryn R; Sink, Ernest L

2016-03-01

Periacetabular osteotomy (PAO) reorients the acetabular cartilage through a complex series of pelvic osteotomies, which risks significant blood loss often necessitating blood transfusion. Therefore, it is important to identify effective strategies to manage blood loss and decrease morbidity after PAO. The purpose of this study was to determine the association of epsilon-aminocaproic acid (EACA), an antifibrinolytic agent, with blood loss from PAO. Ninety-three patients out of 110 consecutive patients that underwent unilateral PAO for acetabular dysplasia met inclusion criteria. Fifty patients received EACA intraoperatively. Demographics, autologous blood predonation, anesthetic type, intraoperative estimated blood loss (EBL), cell-saver utilization, and transfusions were recorded. Total blood loss was calculated. Two-sample t-test and chi-square or Fisher's exact test were used as appropriate. The associations between EACA administration and calculated EBL, cell-saver utilization, intraoperative EBL, and maximum difference in postoperative hemoglobin were assessed via multiple regression, adjusting for confounders. Post hoc power analysis demonstrated sufficient power to detect a 250-mL difference in calculated EBL between groups. Alpha level was 0.05 for all tests. No demographic differences existed between groups. Mean blood loss and allogeneic transfusion rates were not statistically significant between groups (P = .093 and .170, respectively). There were no differences in cell-saver utilization, intraoperative EBL, and/or postoperative hemoglobin. There was a higher rate of autologous blood utilization in the group not receiving EACA because of a clinical practice change. EACA administration was not associated with a statistically significant reduction in blood loss or allogeneic transfusion in patients undergoing PAO. Copyright © 2016 Elsevier Inc. All rights reserved.

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

Haseeb, Syed Abdul; Ahmad, Syed Bilal; Mirza, Sika

Purpose: To assess the impact of radiation treatment delivery through patient inhomogeneities on the secondary barrier shielding requirements in IMRT treatments using Monte Carlo Simulations. Materials and Methods: Scatter factors were calculated at a distance of 1m from the center of a virtual phantom in Geant4.10.01. Phantom (30×30×30 cm{sup 3}) was inserted with lung (30×30×8 cm{sup 3}), stainless steel (5×5×5 cm{sup 3}) and aluminum (5×5×5 cm{sup 3}) to represent the inhomogeneities. Scatter factor was defined according to the NCRP-151 recommendations and was calculated for angles of 3° to 120° with respect to the beam’s central axis. A virtual radiation source,more » with energy sampled from a histogram representing 6 MV FFF beam, was used for irradiation with a field size of 15×15 cm{sup 2} and SSD of 100 cm. Results: Irradiation through the inhomogeneity affects the patient scattered dose. For high Z material inhomogeneities the scattered dose is reduced due to significant attenuation of the primary radiation. On the other hand if the inhomogeneity is a low Z material such as lung the scattered dose is higher by a maximum of 26%. The average increase in scatter factors for the lung phantom was 17% for angles between 3° and 63° compared to the homogeneous water phantom. Conclusions: In IMRT type treatments delivered through low density patient inhomogeneities (lung) the scattered dose increases significantly. Considering a large proportion of patients receiving radiation therapy for lung cancers the increase in the scattered dose should be incorporated in the shielding calculations for the secondary barriers.« less

Decision making measured by the Iowa Gambling Task in alcohol use disorder and gambling disorder: a systematic review and meta-analysis.

PubMed

Kovács, Ildikó; Richman, Mara J; Janka, Zoltán; Maraz, Aniko; Andó, Bálint

2017-12-01

Gambling disorder (GD) and alcohol use disorder (AD) have similar features, such as elevated impulsivity and decision-making deficits, which are directly linked to relapse and poor therapeutic outcomes. Our aim was to assess decision-making characteristics in GD and AD patients compared to healthy controls (HC) based on one of the most frequently used measures of decision-making: the Iowa Gambling Task (IGT). In our systematic literature search of three databases, we identified 1198 empirical articles that mentioned decision-making deficits with the use of the IGT in patients diagnosed with either AD or GD. Possible effects were calculated using meta-analysis. In the end, 17 studies (including 1360 participants) were suitable for inclusion in the meta-analysis reporting data for 23 group contrasts. The random effects estimate indicated impaired IGT performance in both AD patients (N=500; d=-0.581, CI:-89.5<δ<-26.6%) and an even greater deficit in GD patients (N=292; d=-1.034, CI:-156.1<δ<50.7%) compared to HCs. Sampling variances were calculated for both AD (v 1 =0.0056) and GD groups (v 2 =0.0061), from which the z-score was calculated (z=-21.0785; p<0.05), which indicates a statistically significant difference between AD and GD groups. No significant moderating effects of age, gender or education were found. There is enough evidence to support that decision-making deficit associated with addictive disorders, and that the deficit is more expressed in gambling disorder than in alcohol use disorder. Impaired decision-making plays an important part in poor therapeutic outcomes, thus provides a promising opportunity for cognitive intervention. Copyright © 2017 Elsevier B.V. All rights reserved.

Assessing the representativeness of physician and patient respondents to a primary care survey using administrative data.

PubMed

Li, Allanah; Cronin, Shawna; Bai, Yu Qing; Walker, Kevin; Ammi, Mehdi; Hogg, William; Wong, Sabrina T; Wodchis, Walter P

2018-05-30

QUALICOPC is an international survey of primary care performance. QUALICOPC data have been used in several studies, yet the representativeness of the Canadian QUALICOPC survey is unknown, potentially limiting the generalizability of findings. This study examined the representativeness of QUALICOPC physician and patient respondents in Ontario using health administrative data. This representativeness study linked QUALICOPC physician and patient respondents in Ontario to health administrative databases at the Institute for Clinical Evaluative Sciences. Physician respondents were compared to other physicians in their practice group and all Ontario primary care physicians on demographic and practice characteristics. Patient respondents were compared to other patients rostered to their primary care physicians, patients rostered to their physicians' practice groups, and a random sample of Ontario residents on sociodemographic characteristics, morbidity, and health care utilization. Standardized differences were calculated to compare the distribution of characteristics across cohorts. QUALICOPC physician respondents included a higher proportion of younger, female physicians and Canadian medical graduates compared to other Ontario primary care physicians. A higher proportion of physician respondents practiced in Family Health Team models, compared to the provincial proportion for primary care physicians. QUALICOPC patient respondents were more likely to be older and female, with significantly higher levels of morbidity and health care utilization, compared with the other patient groups examined. However, when looking at the QUALICOPC physicians' whole rosters, rather than just the patient survey respondents, the practice profiles were similar to those of the other physicians in their practice groups and Ontario patients in general. Comparisons revealed some differences in responding physicians' demographic and practice characteristics, as well as differences in responding patients' characteristics compared to the other patient groups tested, which may have resulted from the visit-based sampling strategy. Ontario QUALICOPC physicians had similar practice profiles as compared to non-participating physicians, providing some evidence that the participating practices are representative of other non-participating practices, and patients selected by visit-based sampling may also be representative of visiting patients in other practices. Those using QUALICOPC data should understand this limited representativeness when generalizing results, and consider the potential for bias in their analyses.

Novel heparan sulfate assay by using automated high-throughput mass spectrometry: application to monitoring and screening for mucopolysaccharidoses

PubMed Central

Shimada, Tsutomu; Kelly, Joan; LaMarr, William A; van Vlies, Naomi; Yasuda, Eriko; Mason, Robert W.; Mackenzie, William; Kubaski, Francyne; Giugliani, Roberto; Chinen, Yasutsugu; Yamaguchi, Seiji; Suzuki, Yasuyuki; Orii, Kenji E.; Fukao, Toshiyuki; Orii, Tadao; Tomatsu, Shunji

2014-01-01

Mucopolysaccharidoses (MPS) are caused by deficiency of one of a group of specific lysosomal enzymes, resulting in excessive accumulation of glycosaminoglycans (GAGs). We previously developed GAG assay methods using liquid chromatography tandem mass spectrometry (LC-MS/MS); however, it takes 4–5 min per sample for analysis. For the large numbers of samples in a screening program, a more rapid process is desirable. The automated high-throughput mass spectrometry (HT-MS/MS) system (RapidFire) integrates a solid phase extraction robot to concentrate and desalt samples prior to direction into the MS/MS without chromatographic separation; thereby allowing each sample to be processed within ten seconds (enabling screening of more than one million samples per year). The aim of this study was to develop a higher throughput system to assay heparan sulfate (HS) using HT-MS/MS, and to compare its reproducibility, sensitivity and specificity with conventional LC-MS/MS. HS levels were measured in blood (plasma and serum) from control subjects and patients with MPS II, III, or IV and in dried blood spots (DBS) from newborn controls and patients with MPS I, II, or III. Results obtained from HT-MS/MS showed 1) that there was a strong correlation of levels of disaccharides derived from HS in blood, between those calculated using conventional LC-MS/MS and HT-MS/MS, 2) that levels of HS in blood were significantly elevated in patients with MPS II and III, but not in MPS IVA, 3) that the level of HS in patients with a severe form of MPS II was higher than that in an attenuated form, 4) that reduction of blood HS level was observed in MPS II patients treated with enzyme replacement therapy or hematopoietic stem cell transplantation, and 5) that levels of HS in newborn DBS were elevated in patients with MPS I, II or III, compared to control newborns. In conclusion, HT-MS/MS provides much higher throughput than LC-MS/MS-based methods with similar sensitivity and specificity in an HS assay, indicating that HT-MS/MS may be feasible for diagnosis, monitoring, and newborn screening of MPS. PMID:25092413

ABO blood groups, Rhesus negativity, and primary biliary cirrhosis

PubMed Central

Hamlyn, A. N.; Morris, J. S.; Sherlock, S.

1974-01-01

The distribution of blood groups and Rhesus negativity in 91 British patients with primary biliary cirrhosis was compared with a sample of registered blood donors. There were no significant differences from the expected proportions calculated from the control groups. Although the number of cases studied is small the analysis does not confirm previous reports of an excess of A group in the disease. If a genetic basis exists for primary biliary cirrhosis alternative markers must be found. PMID:4211827

The Rapid-Heat LAMPellet Method: A Potential Diagnostic Method for Human Urogenital Schistosomiasis

PubMed Central

Carranza-Rodríguez, Cristina; Pérez-Arellano, José Luis; Vicente, Belén; López-Abán, Julio; Muro, Antonio

2015-01-01

Background Urogenital schistosomiasis due to Schistosoma haematobium is a serious underestimated public health problem affecting 112 million people - particularly in sub-Saharan Africa. Microscopic examination of urine samples to detect parasite eggs still remains as definitive diagnosis. This work was focussed on developing a novel loop-mediated isothermal amplification (LAMP) assay for detection of S. haematobium DNA in human urine samples as a high-throughput, simple, accurate and affordable diagnostic tool to use in diagnosis of urogenital schistosomiasis. Methodology/Principal Findings A LAMP assay targeting a species specific sequence of S. haematobium ribosomal intergenic spacer was designed. The effectiveness of our LAMP was assessed in a number of patients´ urine samples with microscopy confirmed S. haematobium infection. For potentially large-scale application in field conditions, different DNA extraction methods, including a commercial kit, a modified NaOH extraction method and a rapid heating method were tested using small volumes of urine fractions (whole urine, supernatants and pellets). The heating of pellets from clinical samples was the most efficient method to obtain good-quality DNA detectable by LAMP. The detection limit of our LAMP was 1 fg/µL of S. haematobium DNA in urine samples. When testing all patients´ urine samples included in our study, diagnostic parameters for sensitivity and specificity were calculated for LAMP assay, 100% sensitivity (95% CI: 81.32%-100%) and 86.67% specificity (95% CI: 75.40%-94.05%), and also for microscopy detection of eggs in urine samples, 69.23% sensitivity (95% CI: 48.21% -85.63%) and 100% specificity (95% CI: 93.08%-100%). Conclusions/Significance We have developed and evaluated, for the first time, a LAMP assay for detection of S. haematobium DNA in heated pellets from patients´ urine samples using no complicated requirement procedure for DNA extraction. The procedure has been named the Rapid-Heat LAMPellet method and has the potential to be developed further as a field diagnostic tool for use in urogenital schistosomiasis-endemic areas. PMID:26230990

Reliable Diagnosis of Carnitine Palmitoyltransferase Type IA Deficiency by Analysis of Plasma Acylcarnitine Profiles.

PubMed

Heiner-Fokkema, M Rebecca; Vaz, Frédéric M; Maatman, Ronald; Kluijtmans, Leo A J; van Spronsen, Francjan J; Reijngoud, Dirk-Jan

2017-01-01

Carnitine palmitoyltransferase IA (CPT-IA) deficiency is an inherited disorder of the carnitine cycle (MIM #255120). Patients affected by this deficiency might be missed easily because of lack of specific and sensitive biochemical markers. In this study, sensitivity and specificity of plasma free carnitine (C0) and long-chain acylcarnitines (lc-ac: C16:0-, C16:1-, C18:0-, C18:1- and C18:2-ac) was evaluated, including the sum of lc-ac (∑lc-ac) and the molar ratios C0/(C16:0-ac+C18:0-ac) and C0/∑lc-ac. Nine plasma acylcarnitine profiles of 4 CPT-IA deficient patients were compared with profiles of 2,190 subjects suspected of or diagnosed with an inherited disorder of metabolism. Age-dependent reference values were calculated based on the patient population without a definite diagnosis of an inborn error of metabolism (n = 1,600). Sensitivity, specificity, and Receiver Operating Characteristic (ROC) curves were calculated based on samples of the whole patient population. Concentrations of C0 in plasma were normal in all CPT-IA deficient patient samples. ROC analyses showed highest diagnostic values for C18:0-ac, C18:1-ac, and ∑lc-ac (AUC 1.000) and lowest for C0 (AUC 0.738). Combining two markers, i.e., a plasma C18:1-ac concentration <0.05 μmol/L and a molar ratio of C0/(C16:0-ac+C18:0-ac) >587, specificity to diagnose CPT-IA deficiency increased to 99.3% compared with either C18:1-ac (97.4%) or C0/(C16:0-ac+C18:0-ac) (96.9%) alone, all at a sensitivity of 100%. Combination of a low concentration of C18:1-ac with a high molar ratio of C0/(C16:0-ac+C18:0-ac) ratio in plasma has high diagnostic value for CPT-IA deficiency. Patients with a clinical suspicion of CPT-IA deficiency can be diagnosed with this test combination.

The Diagnostic Value of 3-Dimensional Sampling Perfection With Application Optimized Contrasts Using Different Flip Angle Evolutions (SPACE) MRI in Evaluating Lower Extremity Deep Venous Thrombus.

PubMed

Wu, Gang; Xie, Ruyi; Zhang, Xiaoli; Morelli, John; Yan, Xu; Zhu, Xiaolei; Li, Xiaoming

2017-12-01

The aim of this study was to evaluate the diagnostic performance of noncontrast magnetic resonance imaging utilizing sampling perfection with application optimized contrasts using different flip angle evolutions (SPACE) in detecting deep venous thrombus (DVT) of the lower extremity and evaluating clot burden. This prospective study was approved by the institutional review board. Ninety-four consecutive patients (42 men, 52 women; age range, 14-87 years; average age, 52.7 years) suspected of lower extremity DVT underwent ultrasound (US) and SPACE. The venous visualization score for SPACE was determined by 2 radiologists independently according to a 4-point scale (1-4, poor to excellent). The sensitivity and specificity of SPACE in detecting DVT were calculated based on segment, limb, and patient, with US serving as the reference standard. The clot burden for each segment was scored (0-3, patent to entire segment occlusion). The clot burden score obtained with SPACE was compared with US using a Wilcoxon test based on region, limb, and patient. Interobserver agreement in assessing DVT (absent, nonocclusive, or occlusive) with SPACE was determined by calculating Cohen kappa coefficients. The mean venous visualization score for SPACE was 3.82 ± 0.50 for reader 1 and 3.81 ± 0.50 for reader 2. For reader 1, sensitivity/specificity values of SPACE in detecting DVT were 96.53%/99.90% (segment), 95.24%/99.04% (limb), and 95.89%/95.24% (patient). For reader 2, corresponding values were 97.20%/99.90%, 96.39%/99.05%, and 97.22%/95.45%. The clot burden assessed with SPACE was not significantly different from US (P > 0.05 for region, limb, patient). Interobserver agreement of SPACE in assessing thrombosis was excellent (kappa = 0.894 ± 0.014). Non-contrast-enhanced 3-dimensional SPACE magnetic resonance imaging is highly accurate in detecting lower extremity DVT and reliable in the evaluation of clot burden. SPACE could serve as an important alternative for patients in whom US cannot be performed.

Time and expected value of sample information wait for no patient.

PubMed

Eckermann, Simon; Willan, Andrew R

2008-01-01

The expected value of sample information (EVSI) from prospective trials has previously been modeled as the product of EVSI per patient, and the number of patients across the relevant time horizon less those "used up" in trials. However, this implicitly assumes the eligible patient population to which information from a trial can be applied across a time horizon are independent of time for trial accrual, follow-up and analysis. This article demonstrates that in calculating the EVSI of a trial, the number of patients who benefit from trial information should be reduced by those treated outside as well as within the trial over the time until trial evidence is updated, including time for accrual, follow-up and analysis. Accounting for time is shown to reduce the eligible patient population: 1) independent of the size of trial in allowing for time of follow-up and analysis, and 2) dependent on the size of trial for time of accrual, where the patient accrual rate is less than incidence. Consequently, the EVSI and expected net gain (ENG) at any given trial size are shown to be lower when accounting for time, with lower ENG reinforced in the case of trials undertaken while delaying decisions by additional opportunity costs of time. Appropriately accounting for time reduces the EVSI of trial design and increase opportunity costs of trials undertaken with delay, leading to lower likelihood of trialing being optimal and smaller trial designs where optimal.

Length bias correction in one-day cross-sectional assessments - The nutritionDay study.

PubMed

Frantal, Sophie; Pernicka, Elisabeth; Hiesmayr, Michael; Schindler, Karin; Bauer, Peter

2016-04-01

A major problem occurring in cross-sectional studies is sampling bias. Length of hospital stay (LOS) differs strongly between patients and causes a length bias as patients with longer LOS are more likely to be included and are therefore overrepresented in this type of study. To adjust for the length bias higher weights are allocated to patients with shorter LOS. We determined the effect of length-bias adjustment in two independent populations. Length-bias correction is applied to the data of the nutritionDay project, a one-day multinational cross-sectional audit capturing data on disease and nutrition of patients admitted to hospital wards with right-censoring after 30 days follow-up. We applied the weighting method for estimating the distribution function of patient baseline variables based on the method of non-parametric maximum likelihood. Results are validated using data from all patients admitted to the General Hospital of Vienna between 2005 and 2009, where the distribution of LOS can be assumed to be known. Additionally, a simplified calculation scheme for estimating the adjusted distribution function of LOS is demonstrated on a small patient example. The crude median (lower quartile; upper quartile) LOS in the cross-sectional sample was 14 (8; 24) and decreased to 7 (4; 12) when adjusted. Hence, adjustment for length bias in cross-sectional studies is essential to get appropriate estimates. Copyright © 2015 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

Profound loss of neprilysin accompanied by decreased levels of neuropeptides and increased CRP in ulcerative colitis.

PubMed

Sargın, Zeynep Gök; Erin, Nuray; Tazegul, Gokhan; Elpek, Gülsüm Özlem; Yıldırım, Bülent

2017-01-01

Neprilysin (NEP, CD10) acts to limit excessive inflammation partly by hydrolyzing neuropeptides. Although deletion of NEP exacerbates intestinal inflammation in animal models, its role in ulcerative colitis (UC) is not well explored. Herein, we aimed to demonstrate changes in NEP and associated neuropeptides at the same time in colonic tissue. 72 patients with UC and 27 control patients were included. Patients' demographic data and laboratory findings, five biopsy samples from active colitis sites and five samples from uninvolved mucosa were collected. Substance P (SP), calcitonin gene related peptide (CGRP) and vasoactive intestinal peptide (VIP) were extracted from freshly frozen tissues and measured using ELISA. Levels of NEP expression were determined using immunohistochemistry and immunoreactivity scores were calculated. GEBOES grading system was also used. We demonstrated a profound loss (69.4%) of NEP expression in UC, whereas all healthy controls had NEP expression. Patients with UC had lower neuronal SP; however non-neuronal SP remained similar. UC patients had also lower neuronal and non-neuronal VIP levels. CGRP were low in general and no significant changes were observed. Additionally, CRP positive patients with UC had higher rates of NEP loss (80% vs 51.9%) and lower SP levels when compared with CRP negative patients with UC. Concurrent decreases in SP and VIP with profound loss of NEP expression observed in UC is likely to be one of the factors in pathogenesis. Further studies are required to define the role of neuropeptides and NEP in UC.

[Laboratory exams necessity for patients admitted to an university hospital intensive care unity].

PubMed

Machado, Fernando Osni; Silva, Flávia Solano Patrício da; Argente, Juliana Sonego; Moritz, Rachel Duarte

2006-12-01

The progressive increasing diagnostic resources had influenced the quality and quantity of laboratory exams. It is not clear if the amount of exams performed influence the morbidity and mortality in the ICU patients. The purpose of this study was to appraise the frequency of the most ordering tests in the ICU of HU-UFSC and to check if there was connection between them and the age, the destiny until the ICU discharge and the estimate severity of their diseases. Prospective cohort study with qualitative approach. The blood samples of admitted patients were analyzed, from July to December 2005. Clinical and demographic features were collected and the most frequently blood-samples were quantified per day. In the sequence the daily rate of exams were calculated during all the admission period. The patients were analyzed according to three criterions: age, destiny until the ICU discharge and estimate severity according to APACHE II index. Data were analyzed using Fisher Exact, Chi-square and ANOVA tests. One hundred and thirteen patients were enrolled to this study. The average test-ordering was 11.50 per day. These numbers didn't have statistical difference when they were compared between survivor and non-survivor patients, and between those whose the death estimated tax was bigger or smaller than 50 per cent. The test-ordering didn't show clinical and prognostic relation to its request. There were no statistic relation between the patient's age, ICU discharge and the estimate severity.

Relationship of weight status with mental and physical health in female fibromyalgia patients.

PubMed

Aparicio, Virginia A; Ortega, Francisco B; Carbonell-Baeza, Ana; Camiletti, Daniel; Ruiz, Jonatan R; Delgado-Fernández, Manuel

2011-01-01

To analyze the association of weight status with anxiety, depression, quality of life and physical fitness in fibromyalgia (FM) patients. The sample comprised 175 Spanish female FM patients (51.2 ± 7 years). We assessed quality of life by means of the Short-Form-36 Health Survey (SF36) and anxiety and depression by means of the Hospital Anxiety and Depression Scale (HADS). We used standardized fieldbased fitness tests to assess cardiorespiratory fitness, muscular strength, flexibility, agility, and static and dynamic balance. BMI was calculated and categorized using the international criteria. 33% of the sample was normal-weight, 35% overweight and 33% obese. HADS-anxiety and HADS-depression levels increased across the weight status categories. Obese patients had higher anxiety and depression levels compared to normal-weight patients (p < 0.05) whereas no differences were observed between overweight and obese patients. Physical functioning, bodily pain, general health (all p < 0.01) and mental health (p < 0.05) subscales from the SF36 were worse across the weight status categories. Likewise, levels of cardiorespiratory fitness, dynamic balance/motor agility (both p < 0.05) and upper-body flexibility (p < 0.001) decreased as the weight status increased. Pairwise comparisons showed significant differences mainly between the normal-weight versus obese groups. Obese female FM patients displayed higher levels of anxiety and depression and worse quality of life, cardiorespiratory fitness, dynamic balance/motor agility and upper-body flexibility than their normal-weight peers. Copyright © 2011 S. Karger AG, Basel.

How Many Samples and How Many Culture Media To Diagnose a Prosthetic Joint Infection: a Clinical and Microbiological Prospective Multicenter Study

PubMed Central

Léger, Julie; Tandé, Didier; Plouzeau, Chloé; Valentin, Anne Sophie; Jolivet-Gougeon, Anne; Lemarié, Carole; Kempf, Marie; Héry-Arnaud, Geneviève; Bret, Laurent; Juvin, Marie Emmanuelle; Giraudeau, Bruno; Burucoa, Christophe

2015-01-01

Although numerous perioperative samples and culture media are required to diagnose prosthetic joint infection (PJI), their exact number and types have not yet been definitely determined with a high level of proof. We conducted a prospective multicenter study to determine the minimal number of samples and culture media required for accurate diagnosis of PJI. Over a 2-year period, consecutive patients with clinical signs suggesting PJI were included, with five perioperative samples per patient. The bacteriological and PJI diagnosis criteria were assessed using a random selection of two, three, or four samples and compared with those obtained using the recommended five samples (references guidelines). The results obtained with two or three culture media were then compared with those obtained with five culture media for both criteria. The times-to-positivity of the different culture media were calculated. PJI was confirmed in 215/264 suspected cases, with a bacteriological criterion in 192 (89%). The PJI was monomicrobial (85%) or polymicrobial (15%). Percentages of agreement of 98.1% and 99.7%, respectively, for the bacteriological criterion and confirmed PJI diagnosis were obtained when four perioperative samples were considered. The highest percentages of agreement were obtained with the association of three culture media, a blood culture bottle, a chocolate agar plate, and Schaedler broth, incubated for 5, 7, and 14 days, respectively. This new procedure leads to significant cost saving. Our prospective multicenter study showed that four samples seeded on three culture media are sufficient for diagnosing PJI. PMID:26637380

How Many Samples and How Many Culture Media To Diagnose a Prosthetic Joint Infection: a Clinical and Microbiological Prospective Multicenter Study.

PubMed

Bémer, Pascale; Léger, Julie; Tandé, Didier; Plouzeau, Chloé; Valentin, Anne Sophie; Jolivet-Gougeon, Anne; Lemarié, Carole; Kempf, Marie; Héry-Arnaud, Geneviève; Bret, Laurent; Juvin, Marie Emmanuelle; Giraudeau, Bruno; Corvec, Stéphane; Burucoa, Christophe

2016-02-01

Although numerous perioperative samples and culture media are required to diagnose prosthetic joint infection (PJI), their exact number and types have not yet been definitely determined with a high level of proof. We conducted a prospective multicenter study to determine the minimal number of samples and culture media required for accurate diagnosis of PJI. Over a 2-year period, consecutive patients with clinical signs suggesting PJI were included, with five perioperative samples per patient. The bacteriological and PJI diagnosis criteria were assessed using a random selection of two, three, or four samples and compared with those obtained using the recommended five samples (references guidelines). The results obtained with two or three culture media were then compared with those obtained with five culture media for both criteria. The times-to-positivity of the different culture media were calculated. PJI was confirmed in 215/264 suspected cases, with a bacteriological criterion in 192 (89%). The PJI was monomicrobial (85%) or polymicrobial (15%). Percentages of agreement of 98.1% and 99.7%, respectively, for the bacteriological criterion and confirmed PJI diagnosis were obtained when four perioperative samples were considered. The highest percentages of agreement were obtained with the association of three culture media, a blood culture bottle, a chocolate agar plate, and Schaedler broth, incubated for 5, 7, and 14 days, respectively. This new procedure leads to significant cost saving. Our prospective multicenter study showed that four samples seeded on three culture media are sufficient for diagnosing PJI. Copyright © 2016, American Society for Microbiology. All Rights Reserved.

Comparison of patient centeredness of visits to emergency departments, physicians, and dentists for dental problems and injuries.

PubMed

Cohen, Leonard A; Bonito, Arthur J; Eicheldinger, Celia; Manski, Richard J; Macek, Mark D; Edwards, Robert R; Khanna, Niharika

2010-01-01

Patient-centered care has a positive impact on patient health status. This report compares patient assessments of patient centeredness during treatment in hospital emergency departments (EDs) and physician and dentist offices for dental problems and injuries. Participants included low-income White, Black, and Hispanic adults who had experienced a dental problem or injury during the previous 12 months and who visited an emergency department, physician, or dentist for treatment. A stratified random sample of Maryland households participated in a cross-sectional telephone survey. Interviews were completed with 94.8% (401/423) of eligible individuals. Multivariable logistic regression analyses were performed. The measure of predictive power, the pseudo-R2s, calculated for the logistic regression models ranged from 12% to 18% for the analyses of responses to the measures of patient centeredness (satisfaction with treatment, careful listening, thorough explaining, spending enough time, and treated with courtesy and respect). EDs were less likely than dentists to treat patients with great courtesy and respect. Further research is needed to identify factors that support patient-centered care.

Indel analysis by droplet digital PCR: a sensitive method for DNA mixture detection and chimerism analysis.

PubMed

Santurtún, Ana; Riancho, José A; Arozamena, Jana; López-Duarte, Mónica; Zarrabeitia, María T

2017-01-01

Several methods have been developed to determinate genetic profiles from a mixed samples and chimerism analysis in transplanted patients. The aim of this study was to explore the effectiveness of using the droplet digital PCR (ddPCR) for mixed chimerism detection (a mixture of genetic profiles resulting after allogeneic hematopoietic stem cell transplantation (HSCT)). We analyzed 25 DNA samples from patients who had undergone HSCT and compared the performance of ddPCR and two established methods for chimerism detection, based upon the Indel and STRs analysis, respectively. Additionally, eight artificial mixture DNA samples were created to evaluate the sensibility of ddPCR. Our results show that the chimerism percentages estimated by the analysis of a single Indel using ddPCR were very similar to those calculated by the amplification of 15 STRs (r 2  = 0.970) and with the results obtained by the amplification of 38 Indels (r 2  = 0.975). Moreover, the amplification of a single Indel by ddPCR was sensitive enough to detect a minor DNA contributor comprising down to 0.5 % of the sample. We conclude that ddPCR can be a powerful tool for the determination of a genetic profile of forensic mixtures and clinical chimerism analysis when traditional techniques are not sensitive enough.

Calculation of Blood Dose in Patients Treated With 131I Using MIRD, Imaging, and Blood Sampling Methods

PubMed Central

Piruzan, Elham; Haghighatafshar, Mahdi; Faghihi, Reza; Entezarmahdi, Seyed Mohammad

2016-01-01

Abstract Radioiodine therapy is known as the most effective treatment of differentiated thyroid carcinoma (DTC) to ablate remnant thyroid tissue after surgery. In patients with DTC treated with radioiodine, internal radiation dosimetry of radioiodine is useful for radiation risk assessment. The aim of this study is to describe a method to estimate the absorbed dose to the blood using medical internal radiation dosimetry methods. In this study, 23 patients with DTC with different administrated activities, 3.7, 4.62, and 5.55 GBq after thyroidectomy, were randomly selected. Blood dosimetry of treated patients was performed with external whole body counting using a dual-head gamma camera imaging device and also with blood sample activity measurements using a dose calibrator. Absorbed dose to the blood was measured at 2, 6, 12, 24, 48, and 96 hours after the administration of radioiodine with the 2 methods. Based on the results of whole body counting and blood sample activity dose rate measurements, 96 hours after administration of 3.7, 4.62, and 5.55 GBq of radioiodine, absorbed doses to patients’ blood were 0.65 ± 0.20, 0.67 ± 0.18, 0.79 ± 0.51 Gy, respectively. Increasing radioiodine activity from 3.7 to 5.55 GBq increased blood dose significantly, while there was no significant difference in blood dose between radioiodine dosages of 3.7 and 4.62 GBq. Our results revealed a significant correlation between the blood absorbed dose and blood sample activity and between the blood absorbed dose and whole body counts 24 to 48 hours after the administration of radioiodine. PMID:26986171

Patient satisfaction with triage nursing care in Hong Kong.

PubMed

Chan, Jaime Nga Han; Chau, Janita

2005-06-01

This paper reports a study to examine the relationship between patient satisfaction and triage nursing care in order to assist nurses in defining more clearly their roles, and ultimately to improve the quality of care delivered to emergency patients. Patient satisfaction is considered an important indicator of quality care from the perspective of the consumer and has been widely studied in many settings. However, few studies have examined patient satisfaction with emergency nursing services in the particular area of triage. A descriptive, correlational study was conducted in 2001 in one urban acute hospital in Hong Kong using Consumer Emergency Care Satisfaction Scale (CECSS), and patient and nurse demographic data were also collected. Following a power calculation, systematic sampling was carried out, and the final sample consisted of 56 urgent, semi-urgent and non-urgent patients triaged. The response rate was 61%. The majority of the participants were satisfied with their triage nursing care and teaching. However, difficulties were encountered during the data collection process, resulting in a relatively low response rate. Correlational analyses revealed that patient satisfaction with triage nursing care was statistically significantly correlated with age and the type of nursing intervention received. Older people were more satisfied with the teaching offered by triage nurses and patients who had received specific nursing interventions gave more positive ratings on the teaching subscale of the CECSS. There were no statistically significant relationships between patient satisfaction with triage nursing care and nurse characteristics, including gender, work experiences and educational level. Patients were generally satisfied with the care provided by the triage nurses. Measuring patient satisfaction with triage nursing care remains a major challenge for health care providers in emergency care settings.

SU-E-T-538: Evaluation of IMRT Dose Calculation Based on Pencil-Beam and AAA Algorithms.

PubMed

Yuan, Y; Duan, J; Popple, R; Brezovich, I

2012-06-01

To evaluate the accuracy of dose calculation for intensity modulated radiation therapy (IMRT) based on Pencil Beam (PB) and Analytical Anisotropic Algorithm (AAA) computation algorithms. IMRT plans of twelve patients with different treatment sites, including head/neck, lung and pelvis, were investigated. For each patient, dose calculation with PB and AAA algorithms using dose grid sizes of 0.5 mm, 0.25 mm, and 0.125 mm, were compared with composite-beam ion chamber and film measurements in patient specific QA. Discrepancies between the calculation and the measurement were evaluated by percentage error for ion chamber dose and γ〉l failure rate in gamma analysis (3%/3mm) for film dosimetry. For 9 patients, ion chamber dose calculated with AAA-algorithms is closer to ion chamber measurement than that calculated with PB algorithm with grid size of 2.5 mm, though all calculated ion chamber doses are within 3% of the measurements. For head/neck patients and other patients with large treatment volumes, γ〉l failure rate is significantly reduced (within 5%) with AAA-based treatment planning compared to generally more than 10% with PB-based treatment planning (grid size=2.5 mm). For lung and brain cancer patients with medium and small treatment volumes, γ〉l failure rates are typically within 5% for both AAA and PB-based treatment planning (grid size=2.5 mm). For both PB and AAA-based treatment planning, improvements of dose calculation accuracy with finer dose grids were observed in film dosimetry of 11 patients and in ion chamber measurements for 3 patients. AAA-based treatment planning provides more accurate dose calculation for head/neck patients and other patients with large treatment volumes. Compared with film dosimetry, a γ〉l failure rate within 5% can be achieved for AAA-based treatment planning. © 2012 American Association of Physicists in Medicine.

Diabetic patients have abnormal cerebral autoregulation during cardiopulmonary bypass

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

Croughwell, N.; Lyth, M.; Quill, T.J.

1990-11-01

We tested the hypothesis that insulin-dependent diabetic patients with coronary artery bypass graft surgery experience altered coupling of cerebral blood flow and oxygen consumption. In a study of 23 patients (11 diabetics and 12 age-matched controls), cerebral blood flow was measured using 133Xe clearance during nonpulsatile, alpha-stat blood gas managed cardiopulmonary bypass at the conditions of hypothermia and normothermia. In diabetic patients, the cerebral blood flow at 26.6 +/- 2.42 degrees C was 25.3 +/- 14.34 ml/100 g/min and at 36.9 +/- 0.58 degrees C it was 27.3 +/- 7.40 ml/100 g/min (p = NS). The control patients increased cerebralmore » blood flow from 20.7 +/- 6.78 ml/100 g/min at 28.4 +/- 2.81 degrees C to 37.6 +/- 8.81 ml/100 g/min at 36.5 +/- 0.45 degrees C (p less than or equal to 0.005). The oxygen consumption was calculated from jugular bulb effluent and increased from hypothermic values of 0.52 +/- 0.20 ml/100 g/min in diabetics to 1.26 +/- 0.28 ml/100 g/min (p = 0.001) at normothermia and rose from 0.60 +/- 0.27 to 1.49 +/- 0.35 ml/100 g/min (p = 0.0005) in the controls. Thus, despite temperature-mediated changes in oxygen consumption, diabetic patients did not increase cerebral blood flow as metabolism increased. Arteriovenous oxygen saturation gradients and oxygen extraction across the brain were calculated from arterial and jugular bulb blood samples. The increase in arteriovenous oxygen difference between temperature conditions in diabetic patients and controls was significantly different (p = 0.01). These data reveal that diabetic patients lose cerebral autoregulation during cardiopulmonary bypass and compensate for an imbalance in adequate oxygen delivery by increasing oxygen extraction.« less

Utilization Rates of Implantable Cardioverter-Defibrillators for Primary Prevention of Sudden Cardiac Death: A 2012 Calculation for a Midwestern Health Referral Region

PubMed Central

Hoang, Allen; Shen, Changyu; Zheng, James; Taylor, Stanley; Groh, William J; Rosenman, Marc; Buxton, Alfred E.; Chen, Peng-Sheng

2014-01-01

Background Utilization rates (URs) for implantable cardioverter-defibrillators (ICDs) for primary prevention of sudden cardiac death (PPSCD) are lacking in the community. Objective To establish the ICD UR in central Indiana. Methods A query run on two hospitals in a health information exchange database in Indianapolis identified patients between 2011 and 2012 with left ventricular ejection fraction (EF) ≤0.35. ICD-eligibility and utilization were determined from chart review. Results We identified 1,863 patients with at least one low-EF study. Two cohorts were analyzed: 1,672 patients without, and 191 patients with, ICD-9-CM procedure code 37.94 for ICD placement. We manually reviewed a stratified (by hospital) random sample of 300 patients from the no-ICD procedure code cohort and found that 48 (16%) had no ICD but had class I indications for ICD. Eight of 300 (2.7%) actually had ICD implantation for PPSCD. Review of all 191 patients in the ICD procedure code cohort identified 70 with ICD implantation for PPSCD. The ICD UR (ratio between patients with ICD for PPSCD and all with indication) was 38% overall (95% CI 28–49%). URs were 48% for males (95% CI 34–61%), 21% for females (95% CI 16–26%, p=0.0002 vs males), 40% for whites (95% CI 27–53%), and 37% for blacks (95% CI 28–46%, p=0.66 vs whites). Conclusions The ICD UR is 38% among patients meeting Class I indications, suggesting further opportunities to improve guideline compliance. Furthermore, this study illustrates limitations in calculating ICD UR using large electronic repositories without hands-on chart review. PMID:24566233

Fusion positron emission/computed tomography underestimates the presence of hilar nodal metastases in patients with resected non-small cell lung cancer.

PubMed

Carrillo, Sergio A; Daniel, Vincent C; Hall, Nathan; Hitchcock, Charles L; Ross, Patrick; Kassis, Edmund S

2012-05-01

The 5-year survival for patients with resected stage II (N1) non-small cell lung cancer ranges from 40% to 55%. No data exist addressing the benefit of neoadjuvant therapy for patients with stage II disease. This is largely in part due to the lack of a reliable, minimally invasive method to assess hilar nodes. This study is aimed at determining the ability of fusion positron emission/computed tomography (PET/CT) to identify hilar metastases in patients with resected non-small cell lung cancer. A retrospective review of surgically resected patients with fusion PET/CT within 30 days of resection was performed. The sensitivity, specificity, positive predictive value, and negative predictive value for PET/CT in detecting hilar nodal metastases was calculated for a range of maximum standardized uptake values (SUVmax). Hilar nodes from patients with falsely positive PET/CT scans were analyzed for the presence of histoplasmosis. Additionally, the impact of hilar node size greater than 1 centimeter on the calculated values was assessed. There were 119 patients evaluated. The number of lymph nodes resected ranged from 1 to 12 (X=2.98). There was decreased sensitivity and increased specificity with higher SUVmax cutoff values. At the standard SUVmax value of 2.5, the sensitivity and specificity were only 48.5% and 80.2%. The addition of size of hilar node by CT led to a modest improvement in sensitivity at all SUVmax cutoff values. Fusion PET/CT lacks sensitivity and specificity in identifying hilar nodal metastasis in patients with resected non-small cell lung cancer. Further prospective studies assessing the utility of PET/CT versus alternative sampling techniques are warranted. Copyright © 2012 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

Utilization rates of implantable cardioverter-defibrillators for primary prevention of sudden cardiac death: a 2012 calculation for a midwestern health referral region.

PubMed

Hoang, Allen; Shen, Changyu; Zheng, James; Taylor, Stanley; Groh, William J; Rosenman, Marc; Buxton, Alfred E; Chen, Peng-Sheng

2014-05-01

Utilization rates (URs) for implantable cardioverter-defibrillators (ICDs) for primary prevention of sudden cardiac death (PPSCD) are lacking in the community. The purpose of this study was to establish the ICD UR in central Indiana. A query run on 2 hospitals in a health information exchange database in Indianapolis identified patients between 2011 and 2012 with left ventricular ejection fraction (EF) ≤0.35. ICD eligibility and utilization were determined from chart review. We identified 1863 patients with at least 1 low EF study. Two cohorts were analyzed: 1672 patients without and 191 patients with International Classification of Diseases, Ninth Revision, Clinical Modification procedure code 37.94 for ICD placement. We manually reviewed a stratified (by hospital) random sample of 300 patients from the no-ICD procedure code cohort and found that 48 (16%) had no ICD but had class I indications for ICD. Eight of 300 (2.7%) actually had ICD implantation for PPSCD. Review of all 191 patients in the ICD procedure code cohort identified 70 with ICD implantation for PPSCD. The ICD UR (ratio between patients with ICD for PPSCD and all with indication) was 38% overall (95% confidence interval [CI] 28%-49%). URs were 48% for males (95% CI 34%-61%), 21% for females (95% CI 16%-26%, P = .0002 vs males), 40% for whites (95% CI 27%-53%), and 37% for blacks (95% CI 28%-46%, P = .66 vs whites). ICD UR is 38% among patients meeting class I indications, suggesting further opportunities for improving guideline compliance. This study also illustrates limitations in calculating ICD UR using large electronic repositories without hands-on chart review. Copyright © 2014 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

A language-based sum score for the course and therapeutic intervention in primary progressive aphasia.

PubMed

Semler, Elisa; Anderl-Straub, Sarah; Uttner, Ingo; Diehl-Schmid, Janine; Danek, Adrian; Einsiedler, Beate; Fassbender, Klaus; Fliessbach, Klaus; Huppertz, Hans-Jürgen; Jahn, Holger; Kornhuber, Johannes; Landwehrmeyer, Bernhard; Lauer, Martin; Muche, Rainer; Prudlo, Johannes; Schneider, Anja; Schroeter, Matthias L; Ludolph, Albert C; Otto, Markus

2018-04-25

With upcoming therapeutic interventions for patients with primary progressive aphasia (PPA), instruments for the follow-up of patients are needed to describe disease progression and to evaluate potential therapeutic effects. So far, volumetric brain changes have been proposed as clinical endpoints in the literature, but cognitive scores are still lacking. This study followed disease progression predominantly in language-based performance within 1 year and defined a PPA sum score which can be used in therapeutic interventions. We assessed 28 patients with nonfluent variant PPA, 17 with semantic variant PPA, 13 with logopenic variant PPA, and 28 healthy controls in detail for 1 year. The most informative neuropsychological assessments were combined to a sum score, and associations between brain atrophy were investigated followed by a sample size calculation for clinical trials. Significant absolute changes up to 20% in cognitive tests were found after 1 year. Semantic and phonemic word fluency, Boston Naming Test, Digit Span, Token Test, AAT Written language, and Cookie Test were identified as the best markers for disease progression. These tasks provide the basis of a new PPA sum score. Assuming a therapeutic effect of 50% reduction in cognitive decline for sample size calculations, a number of 56 cases is needed to find a significant treatment effect. Correlations between cognitive decline and atrophy showed a correlation up to r = 0.7 between the sum score and frontal structures, namely the superior and inferior frontal gyrus, as well as with left-sided subcortical structures. Our findings support the high performance of the proposed sum score in the follow-up of PPA and recommend it as an outcome measure in intervention studies.

High sensitivity mass spectrometric quantification of serum growth hormone by amphiphilic peptide conjugation

NASA Astrophysics Data System (ADS)

Arsene, Cristian G.; Schulze, Dirk; Kratzsch, Jürgen; Henrion, André

2012-12-01

Amphiphilic peptide conjugation affords a significant increase in sensitivity with protein quantification by electrospray-ionization mass spectrometry. This has been demonstrated here for human growth hormone in serum using N-(3-iodopropyl)-N,N,N-dimethyloctylammonium iodide (IPDOA-iodide) as derivatizing reagent. The signal enhancement achieved in comparison to the method without derivatization enables extension of the applicable concentration range down to the very low concentrations as encountered with clinical glucose suppression tests for patients with acromegaly. The method has been validated using a set of serum samples spiked with known amounts of recombinant 22 kDa growth hormone in the range of 0.48 to 7.65 \\mug/L. The coefficient of variation (CV) calculated, based on the deviation of results from the expected concentrations, was 3.5% and the limit of quantification (LoQ) was determined as 0.4 \\mug/L. The potential of the method as a tool in clinical practice has been demonstrated with patient samples of about 1 \\mug/L.

Neuropsychological functioning in preschool-aged children undergoing evaluation for organ transplant.

PubMed

Antonini, Tanya N; Beer, Stacey S; Miloh, Tamir; Dreyer, William J; Caudle, Susan E

2017-02-01

The purpose of this study was to review the current literature on neuropsychological functioning in two groups of children requiring organ transplants (liver or heart) and present recent clinical data collected through the liver and cardiac transplantation programs at a large pediatric academic medical center. Data included in this study came from 18 patients who completed evaluations for heart transplant (n = 8) or liver transplant (n = 10) between the ages of 2 and 6 years (inclusive). Measures examining neurocognitive, emotional-behavioral, and adaptive functioning were collected as part of standard pre-transplant clinical neuropsychological evaluations. Within each organ group, mean scores were calculated and compared with normative population mean scores using one sample t-tests. In addition, non-parametric binomial tests were calculated to examine whether the proportion of individuals falling more than one standard deviation below the population mean was significantly greater in the patient groups than the normative population base rate of 16%. Patients in both groups performed below normative expectation in several neurocognitive and adaptive domains. However, neither group showed significant difficulties in behavioral or emotional regulation. Results from this study document cognitive delays in preschool-aged children undergoing evaluations for liver transplant or heart transplant, highlighting the importance of intervention and long-term monitoring of these two patient populations, as well as the need for neuropsychologist involvement with transplant teams.

Shape of wear particles found in human knee joints and their relationship to osteoarthritis.

PubMed

Kuster, M S; Podsiadlo, P; Stachowiak, G W

1998-09-01

To analyse and compare the shape of wear particles found in healthy and osteoarthritic human knee joints for monitoring the progress of osteoarthritis, the long-term prognosis and to evaluate therapeutic regimens. Joint particles from seven patients with normal cartilage in all compartments of the knee joint, 12 patients with fibrillation of less than half the cartilage thickness (grade 1), seven patients with fibrillation of more than half the cartilage thickness (grade 2) and four patients with erosions down to bone (grade 3) were analysed. A total of 565 particles were extracted from synovial fluid samples by ferrography and analysed in a scanning electron microscope. A number of numerical descriptors, i.e. boundary fractal dimension, shape factor, convexity and elongation, were calculated for each particle image and correlated to the degree of osteoarthritis using non-parametric tests. Experiments demonstrated that there were significant differences between the numerical descriptors calculated for wear particles from healthy and osteoarthritic knee joints (P < 0.01), suggesting that the particle shape can be used as an indicator of the joint condition. In particular, the fractal dimension of the particle boundary was shown to correlate directly with the degree of osteoarthritis. Numerical analysis of the shape of wear particles found in human knee joints may provide a reliable means for the assessment of cartilage repair after surgical or conservative treatment of osteoarthritis.

Data acquisition with a positron emission tomograph

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

Freifelder, R.; Karp, J.S.

1997-12-31

Positron Emission Tomography (PET) is a clinical imaging modality used in Nuclear Medicine. PET measures functionality rather than anatomical features and is therefore invaluable in the treatment of diseases which are characterized by functional changes in organs rather than anatomical changes. Typical diseases for which PET is used are cancer, epilepsy, and heart disease. While the scanners are not very complex, the performance demands on the devices are high. Excellent spatial resolution, 4-5 mm, and high sensitivity are key to maintaining high image quality. Compensation or suppression of scattered radiation is also necessary for good image quality. The ability tomore » acquire data under high counting rates is also necessary in order to minimize the injected dose to the patient, minimize the patient`s time in the scanner, and finally to minimize blurring due to patient motion. We have adapted various techniques in our data acquisition system which will be reported on in this talk. These include pulse clipping using lumped delay lines, flash ADCs with short sampling time, the use of a local positioning algorithm to limit the number of data words being used in subsequent second level software triggers and calculations, and finally the use of high speed dedicated calculator boards for on-line rebinning and reduction of the data. Modifications to the system to allow for transmission scanning will also be discussed.« less

A new scale for the assessment of performance and capacity of hand function in children with hemiplegic cerebral palsy: reliability and validity studies.

PubMed

Rosa-Rizzotto, M; Visonà Dalla Pozza, L; Corlatti, A; Luparia, A; Marchi, A; Molteni, F; Facchin, P; Pagliano, E; Fedrizzi, E

2014-10-01

In hemiplegic children, the recognition of the activity limitation pattern and the possibility of grading its severity are relevant for clinicians while planning interventions, monitoring results, predicting outcomes. Aim of the study is to examine the reliability and validity of Besta Scale, an instrument used to measure in hemiplegic children from 18 months to 12 years of age both grasp on request (capacity) and spontaneous use of upper limb (performance) in bimanual play activities and in ADL. Psychometric analysis of reliability and of validity of the Besta scale was performed. Outpatient study sample Reliability study: A sample of 39 patients was enrolled. The administration of Besta scale was video-recorded in a standardized manner. All videos were scored by 20 independent raters on subsequent viewing. 3 raters randomly selected from the 20-raters group rescored the same video two years later for intra-rater reliability. Intra and inter-rater reliability were calculated using Intraclass Correlation Coefficient (ICC) and Kendall's coefficient (K), respectively. Internal consistency reliability was assessed using Alpha's Chronbach coefficient. Validity study: a sample of 105 children was assessed 5 times (at t0 and 2, 3, 6 and 12 months later) by 20 independent raters. Each patient underwent at the same time to QUEST and Besta scale administration and assessment. Criterion validity was calculated using rho-Pearson coefficient. Reliability study: The inter-rater reliability calculated with Kendall's coefficient resulted moderate K=0.47. The intra-rater (or test-retest) reliability for 3 raters was excellent (ICC=0.927). The Cronbach's alpha for internal consistency was 0.972. Validity study: Besta scale showed a good criterion validity compared to QUEST increasing by age and severity of impairment. Rho Pearson's correlation coefficient r was 0.81 (P<0.0001). Limitations. Besta scales in infants finds hard to distinguish between mild to moderately impaired hand function. Besta scale scoring system is a valid and reliable tool, utilizable in a clinical setting to monitor evolution of unimanual and bimanual manipulation and to distinguish hand's capacity from performance.

40 CFR 90.706 - Engine sample selection.

Code of Federal Regulations, 2010 CFR

2010-07-01

... = emission test result for an individual engine. x = mean of emission test results of the actual sample. FEL... test with the last test result from the previous model year and then calculate the required sample size.... Test results used to calculate the variables in the following Sample Size Equation must be final...

Applicability and accuracy of pretest probability calculations implemented in the NICE clinical guideline for decision making about imaging in patients with chest pain of recent onset.

PubMed

Roehle, Robert; Wieske, Viktoria; Schuetz, Georg M; Gueret, Pascal; Andreini, Daniele; Meijboom, Willem Bob; Pontone, Gianluca; Garcia, Mario; Alkadhi, Hatem; Honoris, Lily; Hausleiter, Jörg; Bettencourt, Nuno; Zimmermann, Elke; Leschka, Sebastian; Gerber, Bernhard; Rochitte, Carlos; Schoepf, U Joseph; Shabestari, Abbas Arjmand; Nørgaard, Bjarne; Sato, Akira; Knuuti, Juhani; Meijs, Matthijs F L; Brodoefel, Harald; Jenkins, Shona M M; Øvrehus, Kristian Altern; Diederichsen, Axel Cosmus Pyndt; Hamdan, Ashraf; Halvorsen, Bjørn Arild; Mendoza Rodriguez, Vladimir; Wan, Yung Liang; Rixe, Johannes; Sheikh, Mehraj; Langer, Christoph; Ghostine, Said; Martuscelli, Eugenio; Niinuma, Hiroyuki; Scholte, Arthur; Nikolaou, Konstantin; Ulimoen, Geir; Zhang, Zhaoqi; Mickley, Hans; Nieman, Koen; Kaufmann, Philipp A; Buechel, Ronny Ralf; Herzog, Bernhard A; Clouse, Melvin; Halon, David A; Leipsic, Jonathan; Bush, David; Jakamy, Reda; Sun, Kai; Yang, Lin; Johnson, Thorsten; Laissy, Jean-Pierre; Marcus, Roy; Muraglia, Simone; Tardif, Jean-Claude; Chow, Benjamin; Paul, Narinder; Maintz, David; Hoe, John; de Roos, Albert; Haase, Robert; Laule, Michael; Schlattmann, Peter; Dewey, Marc

2018-03-19

To analyse the implementation, applicability and accuracy of the pretest probability calculation provided by NICE clinical guideline 95 for decision making about imaging in patients with chest pain of recent onset. The definitions for pretest probability calculation in the original Duke clinical score and the NICE guideline were compared. We also calculated the agreement and disagreement in pretest probability and the resulting imaging and management groups based on individual patient data from the Collaborative Meta-Analysis of Cardiac CT (CoMe-CCT). 4,673 individual patient data from the CoMe-CCT Consortium were analysed. Major differences in definitions in the Duke clinical score and NICE guideline were found for the predictors age and number of risk factors. Pretest probability calculation using guideline criteria was only possible for 30.8 % (1,439/4,673) of patients despite availability of all required data due to ambiguity in guideline definitions for risk factors and age groups. Agreement regarding patient management groups was found in only 70 % (366/523) of patients in whom pretest probability calculation was possible according to both models. Our results suggest that pretest probability calculation for clinical decision making about cardiac imaging as implemented in the NICE clinical guideline for patients has relevant limitations. • Duke clinical score is not implemented correctly in NICE guideline 95. • Pretest probability assessment in NICE guideline 95 is impossible for most patients. • Improved clinical decision making requires accurate pretest probability calculation. • These refinements are essential for appropriate use of cardiac CT.

Comparison of calculated beta- and gamma-ray doses after the Fukushima accident with data from single-grain luminescence retrospective dosimetry of quartz inclusions in a brick sample

PubMed Central

Endo, Satoru; Fujii, Keisuke; Kajimoto, Tsuyoshi; Tanaka, Kenichi; Stepanenko, Valeriy; Kolyzhenkov, Timofey; Petukhov, Aleksey; Akhmedova, Umukusum; Bogacheva, Viktoriia

2018-01-01

Abstract To estimate the beta- and gamma-ray doses in a brick sample taken from Odaka, Minami-Soma City, Fukushima Prefecture, Japan, a Monte Carlo calculation was performed with Particle and Heavy Ion Transport code System (PHITS) code. The calculated results were compared with data obtained by single-grain retrospective luminescence dosimetry of quartz inclusions in the brick sample. The calculated result agreed well with the measured data. The dose increase measured at the brick surface was explained by the beta-ray contribution, and the slight slope in the dose profile deeper in the brick was due to the gamma-ray contribution. The skin dose was estimated from the calculated result as 164 mGy over 3 years at the sampling site. PMID:29385528

Comparison of calculated beta- and gamma-ray doses after the Fukushima accident with data from single-grain luminescence retrospective dosimetry of quartz inclusions in a brick sample.

PubMed

Endo, Satoru; Fujii, Keisuke; Kajimoto, Tsuyoshi; Tanaka, Kenichi; Stepanenko, Valeriy; Kolyzhenkov, Timofey; Petukhov, Aleksey; Akhmedova, Umukusum; Bogacheva, Viktoriia

2018-05-01

To estimate the beta- and gamma-ray doses in a brick sample taken from Odaka, Minami-Soma City, Fukushima Prefecture, Japan, a Monte Carlo calculation was performed with Particle and Heavy Ion Transport code System (PHITS) code. The calculated results were compared with data obtained by single-grain retrospective luminescence dosimetry of quartz inclusions in the brick sample. The calculated result agreed well with the measured data. The dose increase measured at the brick surface was explained by the beta-ray contribution, and the slight slope in the dose profile deeper in the brick was due to the gamma-ray contribution. The skin dose was estimated from the calculated result as 164 mGy over 3 years at the sampling site.

Checking the relationship between physicians' communication skills and outpatients' satisfaction in the clinics of Isfahan Al-Zahra(S) Hospital in 2011.

PubMed

Rezaei, Fatemeh; Askari, Hedayat Allah

2014-01-01

The quality of communication skills of health care providers has a significant impact on patient treatment consequences. The present research has been conducted to check the relationship of communication skills on the rate of patients' satisfaction in the clinics of one of the hospitals in Isfahan. The checking list was completed by the researcher in the clinics by using the comments of patients or their relatives. Sampling was performed by using the regular random sampling method. This research was a descriptive-analytical study. The used tool was a standard checking list for evaluating the patients' satisfaction and also the researcher-made checking list for the measurement of effective communication skills. The researcher-made checking list for the measurement of effective communication skills was confirmed by the experts with the face validity, structure, content, and reliability (α =87%). After visiting the patient by the physician, the mentioned list was filled by using the patients' comments, and the collected data was analyzed by SPSS software version 16 with calculating the Pearson correlation coefficient and α2. The study showed that there was a significant relationship between the application of communication skills in the five areas of verbal, body language, effective communicating, establishment, patient privacy and patient participation, except for eye communication of the physician with patients' satisfaction (P < 0.05). Using the communication skills by physicians is associated with patients' satisfaction, and it is the cause of increasing the acceptance of the physician by the patient. Therefore, it is suggested that the opportunity to improve the communication skills should be provided in addition to clinical skills in continuing education programs for the medical community.

Pharmacokinetics and Pharmacodynamics of Piperacillin-Tazobactam in 42 Patients Treated with Concomitant CRRT

PubMed Central

Bauer, Seth R.; Salem, Charbel; Connor, Michael J.; Groszek, Joseph; Taylor, Maria E.; Wei, Peilin; Tolwani, Ashita J.

2012-01-01

Summary Background and objectives Current recommendations for piperacillin-tazobactam dosing in patients receiving continuous renal replacement therapy originate from studies with relatively few patients and lower continuous renal replacement therapy doses than commonly used today. This study measured the pharmacokinetic and pharmacodynamic characteristics of piperacillin-tazobactam in patients treated with continuous renal replacement therapy using contemporary equipment and prescriptions. Design, setting, participants, & measurements A multicenter prospective observational study in the intensive care units of two academic medical centers was performed, enrolling patients with AKI or ESRD receiving piperacillin-tazobactam while being treated with continuous renal replacement therapy. Pregnant women, children, and patients with end stage liver disease were excluded from enrollment. Plasma and continuous renal replacement therapy effluent samples were analyzed for piperacillin and tazobactam levels using HPLC. Pharmacokinetic and pharmacodynamic parameters were calculated using standard equations. Multivariate analyses were used to examine the association of patient and continuous renal replacement therapy characteristics with piperacillin pharmacokinetic parameters. Results Forty-two of fifty-five subjects enrolled had complete sampling. Volume of distribution (median=0.38 L/kg, intraquartile range=0.20 L/kg) and elimination rate constants (median=0.104 h−1, intraquartile range=0.052 h−1) were highly variable, and clinical parameters could explain only a small fraction of the large variability in pharmacokinetic parameters. Probability of target attainment for piperacillin was 83% for total drug but only 77% when the unbound fraction was considered. Conclusions There is significant patient to patient variability in pharmacokinetic/pharmacodynamic parameters in patients receiving continuous renal replacement therapy. Many patients did not achieve pharmacodynamic targets, suggesting that therapeutic drug monitoring might optimize therapy. PMID:22282479

[An investigation of the statistical power of the effect size in randomized controlled trials for the treatment of patients with type 2 diabetes mellitus using Chinese medicine].

PubMed

Ma, Li-Xin; Liu, Jian-Ping

2012-01-01

To investigate whether the power of the effect size was based on adequate sample size in randomized controlled trials (RCTs) for the treatment of patients with type 2 diabetes mellitus (T2DM) using Chinese medicine. China Knowledge Resource Integrated Database (CNKI), VIP Database for Chinese Technical Periodicals (VIP), Chinese Biomedical Database (CBM), and Wangfang Data were systematically recruited using terms like "Xiaoke" or diabetes, Chinese herbal medicine, patent medicine, traditional Chinese medicine, randomized, controlled, blinded, and placebo-controlled. Limitation was set on the intervention course > or = 3 months in order to identify the information of outcome assessement and the sample size. Data collection forms were made according to the checking lists found in the CONSORT statement. Independent double data extractions were performed on all included trials. The statistical power of the effects size for each RCT study was assessed using sample size calculation equations. (1) A total of 207 RCTs were included, including 111 superiority trials and 96 non-inferiority trials. (2) Among the 111 superiority trials, fasting plasma glucose (FPG) and glycosylated hemoglobin HbA1c (HbA1c) outcome measure were reported in 9% and 12% of the RCTs respectively with the sample size > 150 in each trial. For the outcome of HbA1c, only 10% of the RCTs had more than 80% power. For FPG, 23% of the RCTs had more than 80% power. (3) In the 96 non-inferiority trials, the outcomes FPG and HbA1c were reported as 31% and 36% respectively. These RCTs had a samples size > 150. For HbA1c only 36% of the RCTs had more than 80% power. For FPG, only 27% of the studies had more than 80% power. The sample size for statistical analysis was distressingly low and most RCTs did not achieve 80% power. In order to obtain a sufficient statistic power, it is recommended that clinical trials should establish clear research objective and hypothesis first, and choose scientific and evidence-based study design and outcome measurements. At the same time, calculate required sample size to ensure a precise research conclusion.

The effect of neck dissection on quality of life after chemoradiation

PubMed Central

Lassig, Amy Anne Donatelli; Duffy, Sonia A.; Fowler, Karen E.; Ronis, David L.; Chepeha, Douglas B.; Terrell, Jeffrey E.

2010-01-01

Objective To determine differences in QOL between head and neck cancer patients receiving chemoradiation versus chemoradiation and neck dissection. Methods A prospective cohort study was conducted at 2 tertiary otolaryngology clinics and a VA. Sample: 103 oropharyngeal Stage IV SCCA patients treated via chemoradiation +/− neck dissection. Intervention: self-administered health survey collecting health, demographic, and QOL information pretreatment and 1 year later. Main outcome measures: QOL via SF-36 and HNQoL. Descriptive statistics were calculated for health / clinical characteristics, demographics, and QOL scores. T-tests evaluated changes in QOL over time. Results 65 patients received chemoradiation and 38 chemoradiation + neck dissection. Only the pain index of the SF-36 showed a significant difference between groups (p<.05) with the neck dissection group reporting greater pain. Conclusions After post-treatment neck dissection, patients experience statistically significant decrement in bodily pain domain scores, but other QOL scores are similar to those of patients undergoing chemoradiation alone. PMID:18922336

Parental representations in drug-dependent patients and their parents.

PubMed

Torresani, S; Favaretto, E; Zimmermann, C

2000-01-01

The Parental Bonding Instrument (PBI), a measure of perceived parental care and protection, was administered to drug-dependent patients and their parents with the aim to assess the reliability of the instrument in such samples and to compare the parental representations across generations. Ninety drug-dependent patients and 44 mothers and 35 fathers participated. Reliability indices were calculated, and parental representations of parents and their offspring were compared. Linear regression analyses were performed with the patient's PBI score as the dependent variable and the mother's and father's PBI scores as predictor variables. The reliability indices were highly satisfactory and varied between 0.61 and 0.91. The parental bonding of patients, fathers, and mothers was similar. All three groups reported high maternal and paternal control and low maternal care, a pattern characteristic of an "affectionless control" rearing style. Maternal care received by the fathers and paternal protection received by the mothers predicted the care and protection they themselves gave to their drug-dependent offspring.

Assessment of the treatment costs of extracorporeal shock wave therapy versus surgical treatment for shoulder diseases.

PubMed

Haake, M; Rautmann, M; Wirth, T

2001-01-01

To determine the actual costs of extracorporeal shock wave therapy (ESWT) in patients with tendinitis of the supraspinatus muscle. A comparison of the costs of surgical treatment versus the costs for ESWT was made. The total accrued costs were determined 12 weeks after intervention, using a sample group of 60 patients with calcifying or noncalcifying tendinitis of the supraspinatus muscle. The costs per case ranged from EUR 2,700 to EUR 4,300 per patient for ESWT and from EUR 13,400 to EUR 23,450 for surgical treatment, dependent on the method of calculation. Approximately 65% of the per-patient cost is attributable to productivity losses in the workplace. In comparable short-term results, costs for operative treatment are 5-7 times higher than for ESWT. The greater trauma caused by an operative procedure leads to patients being off work for a longer period and thus a correspondingly higher social economic burden.

Signs and symptoms of temporomandibular disorders in women and men.

PubMed

Ferreira, Claudia Lúcia Pimenta; Silva, Marco Antônio Moreira Rodrigues da; Felício, Cláudia Maria de

2016-01-01

Women are more likely to present temporomandibular disorders (TMD); however, studies comparing genders in Brazilian samples are rare. To analyze the proportion of men and women, as well as the association between gender and age, problem duration, and TMD symptoms in patients admitted to an university clinic for treatment. Interview and assessment data of protocols from 1,000 patients diagnosed with TMD were collected and analyzed and then divided into two groups, male (n = 177) and female (n = 823). The exploratory analysis was based on contingency tables and χ2 test was carried out. Subsequently, the logistic regression model was used and the odds ratios (OR) concerning the evaluated comparisons were calculated. Females were more prevalent in the sample, and mean ages and TMD duration were similar between the groups, with higher occurrence in young adults (19 to 40 years old). The OR values showed an association between the female gender and the signs/symptoms of pain in the temporomandibular joint, pain in the facial muscles, neck and shoulders, headache, fatigue in the muscles of mastication, otologic symptoms, and dysphonia. Women had two times higher chances of presenting these symptoms than men. In the sample of Brazilian patients with TMD, the number of women who presented a higher prevalence of painful symptoms was greater, followed by otologic symptoms and complaints of dysphonia. The prevalence of joint noise was similar in both studied groups.

Digitised evaluation of speech intelligibility using vowels in maxillectomy patients.

PubMed

Sumita, Y I; Hattori, M; Murase, M; Elbashti, M E; Taniguchi, H

2018-03-01

Among the functional disabilities that patients face following maxillectomy, speech impairment is a major factor influencing quality of life. Proper rehabilitation of speech, which may include prosthodontic and surgical treatments and speech therapy, requires accurate evaluation of speech intelligibility (SI). A simple, less time-consuming yet accurate evaluation is desirable both for maxillectomy patients and the various clinicians providing maxillofacial treatment. This study sought to determine the utility of digital acoustic analysis of vowels for the prediction of SI in maxillectomy patients, based on a comprehensive understanding of speech production in the vocal tract of maxillectomy patients and its perception. Speech samples were collected from 33 male maxillectomy patients (mean age 57.4 years) in two conditions, without and with a maxillofacial prosthesis, and formant data for the vowels /a/,/e/,/i/,/o/, and /u/ were calculated based on linear predictive coding. The frequency range of formant 2 (F2) was determined by differences between the minimum and maximum frequency. An SI test was also conducted to reveal the relationship between SI score and F2 range. Statistical analyses were applied. F2 range and SI score were significantly different between the two conditions without and with a prosthesis (both P < .0001). F2 range was significantly correlated with SI score in both the conditions (Spearman's r = .843, P < .0001; r = .832, P < .0001, respectively). These findings indicate that calculating the F2 range from 5 vowels has clinical utility for the prediction of SI after maxillectomy. © 2017 John Wiley & Sons Ltd.

Race and socioeconomic disparities in national stoma reversal rates.

PubMed

Zafar, Syed Nabeel; Changoor, Navin R; Williams, Kibileri; Acosta, Rafael D; Greene, Wendy R; Fullum, Terrence M; Haider, Adil H; Cornwell, Edward E; Tran, Daniel D

2016-04-01

Many temporary stomas are never reversed leading to significantly worse quality of life. Recent evidence suggests a lower rate of reversal among minority patients. Our study aimed to elucidate disparities in national stoma closure rates by race, medical insurance status, and household income. Five years of data from the Nationwide Inpatient Sample (2008 to 2012) was used to identify the annual rates of stoma formation and annual rates of stoma closure. Stomas labeled as "permanent" or those created secondary to colorectal cancers were excluded. Temporary stoma closure rates were calculated, and differences were tested with the chi-square test. Separate analyses were performed by race/ethnicity, insurance status, and household income. Nationally representative estimates were calculated using discharge-level weights. The 5-year average annual rate of temporary stoma creation was 76,551 per year (46% colostomies and 54% ileostomies). The annual rate of stoma reversal was 50,155 per year that equated to an annual reversal rate of 65.5%. Reversal rates were higher among white patients compared with black patients (67% vs 56%, P < .001) and among privately insured patients compared with uninsured patients (88% vs 63%, P < .001). Reversal rates increased as the household income increased from 61% in the lowest income quartile to 72% in the highest quartile (P < .001). Stark disparities exist in national rates of stoma closure. Stoma closure is associated with race, insurance, and income status. This study highlights the lack of access to surgical health care among patients of minority race and low-income status. Copyright © 2016 Elsevier Inc. All rights reserved.

The relation between intensity and complexity of coronary artery lesion and oxidative stress in patients with acute coronary syndrome.

PubMed

Turan, Turhan; Menteşe, Ümit; Ağaç, Mustafa Tarık; Akyüz, Ali Rıza; Kul, Selim; Aykan, Ahmet Çağrı; Bektaş, Hüseyin; Korkmaz, Levent; Öztaş Menteşe, Seda; Dursun, İhsan; Çelik, Şükrü

2015-10-01

Oxidative stress plays a major role in the development of atherosclerosis. However, the relationship between oxidative stress and complexity and intensity of coronary artery disease is less clear. The aim of this study is to assess the relationship between oxidative stress markers and the complexity and intensity of coronary artery disease in patients with acute coronary syndrome (ACS). Sixty-seven consecutive patients with an early phase of ACS (<3 h) were included in this single-centre, cross-sectional, prospective study. Syntax and Gensini scores were calculated based on angiographic findings. Patients were divided into two CAD complexity groups according to their Syntax scores: low SYNTAX score (<22) and moderate to high SYNTAX score (>=22). Likewise patients were divided into two CAD severity groups according to the median Gensini score of 64: less intensive CAD with Gensini score (<64) and intensive CAD with Gensini score >=64. Blood samples were taken in 1 hour within administration in order to measure total oxidative status (TOS) and total antioxidant capacity (TAC) levels determined by Erel method. Oxidative stress index (OSI) was calculated by TOS /TAC. There was no significant difference between the two SYNTAX groups for oxidative stress markers. Median TOS and OSI values were significantly high in the intensive CAD group (p=0.005, p=0.04, respectively). The Gensini score was positively correlated with TOS and OSI (p=0.003, p=0.02, respectively). Oxidative stress markers may be considered supportive laboratory parameters related to CAD intensity but not complexity in ACS patients.

Neurological Soft Signs in Schizophrenia: A Meta-analysis

PubMed Central

Chan, Raymond C. K.; Xu, Ting; Heinrichs, R. Walter; Yu, Yue; Wang, Ya

2010-01-01

Background: Neurological soft signs (NSS) are hypothesized as candidate endophenotypes for schizophrenia, but their prevalence and relations with clinical and demographic data are unknown. The authors undertook a quantification (meta-analysis) of the published literature on NSS in patients with schizophrenia and healthy controls. A systematic search was conducted for published articles reporting NSS and related data using standard measures in schizophrenia and healthy comparison groups. Method: A systematic search was conducted for published articles reporting data on the prevalence of NSS in schizophrenia using standard clinical rating scales and healthy comparison groups. Meta-analyses were performed using the Comprehensive Meta-analysis software package. Effect sizes (Cohen d) indexing the difference between schizophrenic patients and the healthy controls were calculated on the basis of reported statistics. Potential moderator variables evaluated included age of patient samples, level of education, sample sex proportions, medication doses, and negative and positive symptoms. Results: A total of 33 articles met inclusion criteria for the meta-analysis. A large and reliable group difference (Cohen d) indicated that, on average, a majority of patients (73%) perform outside the range of healthy subjects on aggregate NSS measures. Cognitive performance and positive and negative symptoms share 2%–10% of their variance with NSS. Conclusions: NSS occur in a majority of the schizophrenia patient population and are largely distinct from symptomatic and cognitive features of the illness. PMID:19377058

Cephalometric norms from posteroanterior Ricketts' cephalograms from Hispanic Americans Peruvian non adult patients.

PubMed

Pérez, Iván E; Chávez, Allison K; Ponce, Darío

2011-01-01

The purpose of the present study was to describe the posteroanterior cephalometric norm values from Hispanic Americans Peruvian non adults patients between years 2009 to 2010, identify possible differences between sexes and compare our results with similar studies in the literature. Data from posteroanterior cephalograms from 318 patients (177 females and 141 males) between 9 and 18 years old were collected from our database; mean and standard deviation were calculated for each gender and age group. Independent samples T-test found statistically significant differences between males and females results in the intermolar width, right molar to maxillae distance, nasal width, nasal height, maxillary width, mandibular width and facial width. statistically differences between sexes were found in seven from twelve transversal measurements. The norm values found in this study are similar to those reported by Ricketts'.

A novel method to quantify and compare anatomical shape: application in cervix cancer radiotherapy

NASA Astrophysics Data System (ADS)

Oh, Seungjong; Jaffray, David; Cho, Young-Bin

2014-06-01

Adaptive radiation therapy (ART) had been proposed to restore dosimetric deficiencies during treatment delivery. In this paper, we developed a technique of Geometric reLocation for analyzing anatomical OBjects' Evolution (GLOBE) for a numerical model of tumor evolution under radiation therapy and characterized geometric changes of the target using GLOBE. A total of 174 clinical target volumes (CTVs) obtained from 32 cervical cancer patients were analyzed. GLOBE consists of three main steps; step (1) deforming a 3D surface object to a sphere by parametric active contour (PAC), step (2) sampling a deformed PAC on 642 nodes of icosahedron geodesic dome for reference frame, and step (3) unfolding 3D data to 2D plane for convenient visualization and analysis. The performance was evaluated with respect to (1) convergence of deformation (iteration number and computation time) and (2) accuracy of deformation (residual deformation). Based on deformation vectors from planning CTV to weekly CTVs, target specific (TS) margins were calculated on each sampled node of GLOBE and the systematic (Σ) and random (σ) variations of the vectors were calculated. Population based anisotropic (PBA) margins were generated using van Herk's margin recipe. GLOBE successfully modeled 152 CTVs from 28 patients. Fast convergence was observed for most cases (137/152) with the iteration number of 65 ± 74 (average ± STD) and the computation time of 13.7 ± 18.6 min. Residual deformation of PAC was 0.9 ± 0.7 mm and more than 97% was less than 3 mm. Margin analysis showed random nature of TS-margin. As a consequence, PBA-margins perform similarly to ISO-margins. For example, PBA-margins for 90% patients' coverage with 95% dose level is close to 13 mm ISO-margins in the aspect of target coverage and OAR sparing. GLOBE demonstrates a systematic analysis of tumor motion and deformation of patients with cervix cancer during radiation therapy and numerical modeling of PBA-margin on 642 locations of CTV surface.

Effect of blood sampling schedule and method of calculating the area under the curve on validity and precision of glycaemic index values.

PubMed

Wolever, Thomas M S

2004-02-01

To evaluate the suitability for glycaemic index (GI) calculations of using blood sampling schedules and methods of calculating area under the curve (AUC) different from those recommended, the GI values of five foods were determined by recommended methods (capillary blood glucose measured seven times over 2.0 h) in forty-seven normal subjects and different calculations performed on the same data set. The AUC was calculated in four ways: incremental AUC (iAUC; recommended method), iAUC above the minimum blood glucose value (AUCmin), net AUC (netAUC) and iAUC including area only before the glycaemic response curve cuts the baseline (AUCcut). In addition, iAUC was calculated using four different sets of less than seven blood samples. GI values were derived using each AUC calculation. The mean GI values of the foods varied significantly according to the method of calculating GI. The standard deviation of GI values calculating using iAUC (20.4), was lower than six of the seven other methods, and significantly less (P<0.05) than that using netAUC (24.0). To be a valid index of food glycaemic response independent of subject characteristics, GI values in subjects should not be related to their AUC after oral glucose. However, calculating GI using AUCmin or less than seven blood samples resulted in significant (P<0.05) relationships between GI and mean AUC. It is concluded that, in subjects without diabetes, the recommended blood sampling schedule and method of AUC calculation yields more valid and/or more precise GI values than the seven other methods tested here. The only method whose results agreed reasonably well with the recommended method (ie. within +/-5 %) was AUCcut.

Comparative Risk Predictions of Second Cancers After Carbon-Ion Therapy Versus Proton Therapy

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

Eley, John G., E-mail: jeley@som.umaryland.edu; University of Texas Graduate School of Biomedical Sciences, Houston, Texas; Department of Radiation Oncology, University of Maryland School of Medicine, Baltimore, Maryland

Purpose: This work proposes a theoretical framework that enables comparative risk predictions for second cancer incidence after particle beam therapy for different ion species for individual patients, accounting for differences in relative biological effectiveness (RBE) for the competing processes of tumor initiation and cell inactivation. Our working hypothesis was that use of carbon-ion therapy instead of proton therapy would show a difference in the predicted risk of second cancer incidence in the breast for a sample of Hodgkin lymphoma (HL) patients. Methods and Materials: We generated biologic treatment plans and calculated relative predicted risks of second cancer in the breastmore » by using two proposed methods: a full model derived from the linear quadratic model and a simpler linear-no-threshold model. Results: For our reference calculation, we found the predicted risk of breast cancer incidence for carbon-ion plans-to-proton plan ratio, , to be 0.75 ± 0.07 but not significantly smaller than 1 (P=.180). Conclusions: Our findings suggest that second cancer risks are, on average, comparable between proton therapy and carbon-ion therapy.« less

Comparative Risk Predictions of Second Cancers After Carbon-Ion Therapy Versus Proton Therapy.

PubMed

Eley, John G; Friedrich, Thomas; Homann, Kenneth L; Howell, Rebecca M; Scholz, Michael; Durante, Marco; Newhauser, Wayne D

2016-05-01

This work proposes a theoretical framework that enables comparative risk predictions for second cancer incidence after particle beam therapy for different ion species for individual patients, accounting for differences in relative biological effectiveness (RBE) for the competing processes of tumor initiation and cell inactivation. Our working hypothesis was that use of carbon-ion therapy instead of proton therapy would show a difference in the predicted risk of second cancer incidence in the breast for a sample of Hodgkin lymphoma (HL) patients. We generated biologic treatment plans and calculated relative predicted risks of second cancer in the breast by using two proposed methods: a full model derived from the linear quadratic model and a simpler linear-no-threshold model. For our reference calculation, we found the predicted risk of breast cancer incidence for carbon-ion plans-to-proton plan ratio, , to be 0.75 ± 0.07 but not significantly smaller than 1 (P=.180). Our findings suggest that second cancer risks are, on average, comparable between proton therapy and carbon-ion therapy. Copyright © 2016 Elsevier Inc. All rights reserved.

PubMed Central

SERDAROGLU OFLAZER, P.; DEYMEER, F.; PARMAN, Y.

2011-01-01

SUMMARY In a muscle biopsy based study, only 9 out of 5450 biopsy samples, received from all parts of greater Istanbul area, had typical clinical and most suggestive light microscopic sporadic-inclusion body myositis (s-IBM) findings. Two other patients with and ten further patients without characteristic light microscopic findings had referring diagnosis of s-IBM. As the general and the ageadjusted populations of Istanbul in 2010 were 13.255.685 and 2.347.300 respectively, the calculated corresponding ‘estimated prevalences' of most suggestive s-IBM in the Istanbul area were 0.679 X 10-6 and 3.834 X 10-6. Since Istanbul receives heavy migration from all regions of Turkey and ours is the only muscle pathology laboratory in Istanbul, projection of these figures to the Turkish population was considered to be reasonable and an estimate of the prevalence of s-IBM in Turkey was obtained. The calculated ‘estimated prevalence' of s-IBM in Turkey is lower than the previously reported rates from other countries. The wide variation in the prevalence rates of s-IBM may reflect different genetic, immunogenetic or environmental factors in different populations. PMID:21842592

Accounting for receptor flexibility and enhanced sampling methods in computer-aided drug design.

PubMed

Sinko, William; Lindert, Steffen; McCammon, J Andrew

2013-01-01

Protein flexibility plays a major role in biomolecular recognition. In many cases, it is not obvious how molecular structure will change upon association with other molecules. In proteins, these changes can be major, with large deviations in overall backbone structure, or they can be more subtle as in a side-chain rotation. Either way the algorithms that predict the favorability of biomolecular association require relatively accurate predictions of the bound structure to give an accurate assessment of the energy involved in association. Here, we review a number of techniques that have been proposed to accommodate receptor flexibility in the simulation of small molecules binding to protein receptors. We investigate modifications to standard rigid receptor docking algorithms and also explore enhanced sampling techniques, and the combination of free energy calculations and enhanced sampling techniques. The understanding and allowance for receptor flexibility are helping to make computer simulations of ligand protein binding more accurate. These developments may help improve the efficiency of drug discovery and development. Efficiency will be essential as we begin to see personalized medicine tailored to individual patients, which means specific drugs are needed for each patient's genetic makeup. © 2012 John Wiley & Sons A/S.

Factors affecting the death anxiety levels of relatives of cancer patients undergoing treatment.

PubMed

Beydag, Kerime Derya

2012-01-01

This descriptive study was performed to determine levels of the death anxiety levels of relatives of patients who being treated in a public hospital located in the Asian side of Istanbul and influencing factors. The sample was 106 patient relatives of patients from oncology or chemotherapy units of the hospital. Data were collected between May-June 2011 with the 15-item Death Anxiety Scale developed by Templer (1970) and adapted to Turkish by Senol (1989) and evaluated by number-percentage calculations, the Kruskal Wallis, Anova and t tests. Some 36.8% of the included group were aged 45 years and over, 57.5% were female and 65.1% were married. A statistically significant difference was found between the age groups, genders of the patient relatives, the period of cancer treatment regarding the death anxiety levels (p<0.05). The death anxiety levels of the patient relatives who were in the 17-39 age group, female and had a patient who was under treatment for less than 6 months were found to high as compared to others.

Risk and Prognosis of Bacteremia and Fungemia Among Peritoneal Dialysis Patients: A Population-Based Cohort Study.

PubMed

Dalgaard, Lars Skov; Nørgaard, Mette; Povlsen, Johan Vestergaard; Jespersen, Bente; Jensen-Fangel, Søren; Ellermann-Eriksen, Svend; Østergaard, Lars; Schønheyder, Henrik Carl; Søgaard, Ole Schmeltz

♦ BACKGROUND: The incidence of bacteremia and fungemia (BAF) is largely unknown in end-stage renal disease (ESRD) patients initiating peritoneal dialysis (PD). ♦ OBJECTIVE: The main objective was to estimate and compare incidence rates of first episodes of BAF in incident PD patients and a comparison cohort. A secondary objective was to compare causative agents and 30-day post-BAF mortality between PD patients and the comparison cohort. ♦ METHODS: Design: Observational cohort study. Central and North Denmark regions. patients who initiated PD during 1995 - 2010. For each patient we sampled up to 10 controls from the general population matched on age, sex, and municipality. ♦ MAIN OUTCOME: Data on positive blood cultures were retrieved from electronic microbiology databases covering the 2 regions. We calculated incidence rates (IRs) of first-time BAF for PD patients and population controls. Incidence-rate ratios (IRRs) were calculated to compare these rates. Thirty-day mortality was estimated by Kaplan-Meier analysis. ♦ RESULTS: Among 1,024 PD patients and 10,215 population controls, we identified 75 and 282 episodes of BAF, respectively. Incidence rates of BAF were 4.7 (95% confidence interval [CI], 3.8 - 5.9) per 100 person-years of follow-up (PYFU) in PD patients and 0.5 (95% CI, 0.4 - 0.5) per 100 PYFU in population controls (IRR = 10.4; 95% CI, 8.1 - 13.5). In PD patients, the most frequent microorganisms were Escherichia coli (18.7%) and Staphylococcus aureus (13.3%). Escherichia coli (27.3%) also ranked first among population controls. Thirty-day mortality following BAF was 20.8% (95% CI, 12.6 - 31.0) and 20.7% (95% CI, 16.3 - 25.9) among PD patients and population controls, respectively. ♦ CONCLUSIONS: Peritoneal dialysis patients are at markedly higher risk of BAF than population controls. Causative agents and the 30-day post-BAF mortality were similar in the 2 cohorts. Copyright © 2016 International Society for Peritoneal Dialysis.

A novel semi-quantitative method for measuring tissue bleeding.

PubMed

Vukcevic, G; Volarevic, V; Raicevic, S; Tanaskovic, I; Milicic, B; Vulovic, T; Arsenijevic, S

2014-03-01

In this study, we describe a new semi-quantitative method for measuring the extent of bleeding in pathohistological tissue samples. To test our novel method, we recruited 120 female patients in their first trimester of pregnancy and divided them into three groups of 40. Group I was the control group, in which no dilation was applied. Group II was an experimental group, in which dilation was performed using classical mechanical dilators. Group III was also an experimental group, in which dilation was performed using a hydraulic dilator. Tissue samples were taken from the patients' cervical canals using a Novak's probe via energetic single-step curettage prior to any dilation in Group I and after dilation in Groups II and III. After the tissue samples were prepared, light microscopy was used to obtain microphotographs at 100x magnification. The surfaces affected by bleeding were measured in the microphotographs using the Autodesk AutoCAD 2009 program and its "polylines" function. The lines were used to mark the area around the entire sample (marked A) and to create "polyline" areas around each bleeding area on the sample (marked B). The percentage of the total area affected by bleeding was calculated using the formula: N = Bt x 100 / At where N is the percentage (%) of the tissue sample surface affected by bleeding, At (A total) is the sum of the surfaces of all of the tissue samples and Bt (B total) is the sum of all the surfaces affected by bleeding in all of the tissue samples. This novel semi-quantitative method utilizes the Autodesk AutoCAD 2009 program, which is simple to use and widely available, thereby offering a new, objective and precise approach to estimate the extent of bleeding in tissue samples.

Decompressive Surgery for the Treatment of Malignant Infarction of the Middle Cerebral Artery (DESTINY): a randomized, controlled trial.

PubMed

Jüttler, Eric; Schwab, Stefan; Schmiedek, Peter; Unterberg, Andreas; Hennerici, Michael; Woitzik, Johannes; Witte, Steffen; Jenetzky, Ekkehart; Hacke, Werner

2007-09-01

Decompressive surgery (hemicraniectomy) for life-threatening massive cerebral infarction represents a controversial issue in neurocritical care medicine. We report here the 30-day mortality and 6- and 12-month functional outcomes from the DESTINY trial. DESTINY (ISRCTN01258591) is a prospective, multicenter, randomized, controlled, clinical trial based on a sequential design that used mortality after 30 days as the first end point. When this end point was reached, patient enrollment was interrupted as per protocol until recalculation of the projected sample size was performed on the basis of the 6-month outcome (primary end point=modified Rankin Scale score, dichotomized to 0 to 3 versus 4 to 6). All analyses were based on intention to treat. A statistically significant reduction in mortality was reached after 32 patients had been included: 15 of 17 (88%) patients randomized to hemicraniectomy versus 7 of 15 (47%) patients randomized to conservative therapy survived after 30 days (P=0.02). After 6 and 12 months, 47% of patients in the surgical arm versus 27% of patients in the conservative treatment arm had a modified Rankin Scale score of 0 to 3 (P=0.23). DESTINY showed that hemicraniectomy reduces mortality in large hemispheric stroke. With 32 patients included, the primary end point failed to demonstrate statistical superiority of hemicraniectomy, and the projected sample size was calculated to 188 patients. Despite this failure to meet the primary end point, the steering committee decided to terminate the trial in light of the results of the joint analysis of the 3 European hemicraniectomy trials.

Visualisation of brain tumors and quantitation of the protein synthesis rate with L-1-[C-11]-tyrosine

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

Pruim, J.; Willemsen, A.T.M.; Waarde, A. van

1994-05-01

We have developed the tracer L-1-[C-11]-tyrosine (TYR) for the quantitation of the protein synthesis rate (PSR) in tumours. Here the first results with TYR in a group of patients with (suspected) primary or recurrent brain tumours are reported. Twenty-six patients were studied: 12 male, 14 female, age 45{plus_minus}16 (mean{plus_minus}S.D.) years. At the time of the study the diagnosis of a primary tumour or recurrent tumour was considered on the basis of clinical symptoms and CT/MRI. Patients received 237{plus_minus}111 MBq TYR i.v. Seventeen patients were studied in a dynamic mode (frame sequence: 10 x 0.5, 3 x 5, 3 x 10more » minutes). During the studies, arterial blood samples were taken for measurement of the input function, and the assessment of metabolites ([C-11]CO{sub 2}, [C-11]proteins). ROIs were placed over the tumour and using a modified Patlak-analysis the PSR was calculated. In the other 9 patients a static emission scan was made, 20-40 min after injection. All images were corrected for attenuation via a transmission scan. Histology or cytology of the tumour was obtained shortly after the TYR-PET in 20 patients. The calculated PSR of the tumours was 1.0{plus_minus}0.6 nmol/ml/min. This is in range with our animal experiments. The PSR in brain tissue of the contralateral hemisphere was 0.7{plus_minus}0.4 nmol/ml/min. Sixteen of the turnouts were correctly identified with TYR-PET. Also, 2 benign lesions were correctly identified. TYR-PET gave 1 false-positive (infarction) and 1 false-negative (astrocytoma of intermediate malignancy) result. In a few patients with extensive peri-tumoural edema on MRI/CT, additional tumour locations were found with TYR-PET, proven to be malignant on biopsy. In conclusion: TYR is applicable for the visualisation of brain tumours. The possibility of calculating a PSR allows its use in the evaluation of therapy.« less

Systolic MOLLI T1 mapping with heart-rate-dependent pulse sequence sampling scheme is feasible in patients with atrial fibrillation.

PubMed

Zhao, Lei; Li, Songnan; Ma, Xiaohai; Greiser, Andreas; Zhang, Tianjing; An, Jing; Bai, Rong; Dong, Jianzeng; Fan, Zhanming

2016-03-15

T1 mapping enables assessment of myocardial characteristics. As the most common type of arrhythmia, atrial fibrillation (AF) is often accompanied by a variety of cardiac pathologies, whereby the irregular and usually rapid ventricle rate of AF may cause inaccurate T1 estimation due to mis-triggering and inadequate magnetization recovery. We hypothesized that systolic T1 mapping with a heart-rate-dependent (HRD) pulse sequence scheme may overcome this issue. 30 patients with AF and 13 healthy volunteers were enrolled and underwent cardiovascular magnetic resonance (CMR) at 3 T. CMR was repeated for 3 patients after electric cardioversion and for 2 volunteers after lowering heart rate (HR). A Modified Look-Locker Inversion Recovery (MOLLI) sequence was acquired before and 15 min after administration of 0.1 mmol/kg gadopentetate dimeglumine. For AF patients, both the fixed 5(3)3/4(1)3(1)2 and the HRD sampling scheme were performed at diastole and systole, respectively. The HRD pulse sequence sampling scheme was 5(n)3/4(n)3(n)2, where n was determined by the heart rate to ensure adequate magnetization recovery. Image quality of T1 maps was assessed. T1 times were measured in myocardium and blood. Extracellular volume fraction (ECV) was calculated. In volunteers with repeated T1 mapping, the myocardial native T1 and ECV generated from the 1st fixed sampling scheme were smaller than from the 1st HRD and 2nd fixed sampling scheme. In healthy volunteers, the overall native T1 times and ECV of the left ventricle (LV) in diastolic T1 maps were greater than in systolic T1 maps (P < 0.01, P < 0.05). In the 3 AF patients that had received electrical cardioversion therapy, the myocardial native T1 times and ECV generated from the fixed sampling scheme were smaller than in the 1st and 2nd HRD sampling scheme (all P < 0.05). In patients with AF (HR: 88 ± 20 bpm, HR fluctuation: 12 ± 9 bpm), more T1 maps with artifact were found in diastole than in systole (P < 0.01). The overall native T1 times and ECV of the left ventricle (LV) in diastolic T1 maps were greater than systolic T1 maps, either with fixed or HRD sampling scheme (all P < 0.05). Systolic MOLLI T1 mapping with heart-rate-dependent pulse sequence scheme can improve image quality and avoid T1 underestimation. It is feasible and with further validation may extend clinical applicability of T1 mapping to patients with atrial fibrillation.

Development and first evaluation of a novel multiplex real-time PCR on whole blood samples for rapid pathogen identification in critically ill patients with sepsis.

PubMed

van de Groep, Kirsten; Bos, Martine P; Savelkoul, Paul H M; Rubenjan, Anna; Gazenbeek, Christel; Melchers, Willem J G; van der Poll, Tom; Juffermans, Nicole P; Ong, David S Y; Bonten, Marc J M; Cremer, Olaf L

2018-04-26

Molecular tests may enable early adjustment of antimicrobial therapy and be complementary to blood culture (BC) which has imperfect sensitivity in critically ill patients. We evaluated a novel multiplex real-time PCR assay to diagnose bloodstream pathogens directly in whole blood samples (BSI-PCR). BSI-PCR included 11 species- and four genus-specific PCRs, a molecular Gram-stain PCR, and two antibiotic resistance markers. We collected 5 mL blood from critically ill patients simultaneously with clinically indicated BC. Microbial DNA was isolated using the Polaris method followed by automated DNA extraction. Sensitivity and specificity were calculated using BC as reference. BSI-PCR was evaluated in 347 BC-positive samples (representing up to 50 instances of each pathogen covered by the test) and 200 BC-negative samples. Bacterial species-specific PCR sensitivities ranged from 65 to 100%. Sensitivity was 26% for the Gram-positive PCR, 32% for the Gram-negative PCR, and ranged 0 to 7% for yeast PCRs. Yeast detection was improved to 40% in a smaller set-up. There was no overall association between BSI-PCR sensitivity and time-to-positivity of BC (which was highly variable), yet Ct-values were lower for true-positive versus false-positive PCR results. False-positive results were observed in 84 (4%) of the 2200 species-specific PCRs in 200 culture-negative samples, and ranged from 0 to 6% for generic PCRs. Sensitivity of BSI-PCR was promising for individual bacterial pathogens, but still insufficient for yeasts and generic PCRs. Further development of BSI-PCR will focus on improving sensitivity by increasing input volumes and on subsequent implementation as a bedside test.

Sample Size in Clinical Cardioprotection Trials Using Myocardial Salvage Index, Infarct Size, or Biochemical Markers as Endpoint.

PubMed

Engblom, Henrik; Heiberg, Einar; Erlinge, David; Jensen, Svend Eggert; Nordrehaug, Jan Erik; Dubois-Randé, Jean-Luc; Halvorsen, Sigrun; Hoffmann, Pavel; Koul, Sasha; Carlsson, Marcus; Atar, Dan; Arheden, Håkan

2016-03-09

Cardiac magnetic resonance (CMR) can quantify myocardial infarct (MI) size and myocardium at risk (MaR), enabling assessment of myocardial salvage index (MSI). We assessed how MSI impacts the number of patients needed to reach statistical power in relation to MI size alone and levels of biochemical markers in clinical cardioprotection trials and how scan day affect sample size. Controls (n=90) from the recent CHILL-MI and MITOCARE trials were included. MI size, MaR, and MSI were assessed from CMR. High-sensitivity troponin T (hsTnT) and creatine kinase isoenzyme MB (CKMB) levels were assessed in CHILL-MI patients (n=50). Utilizing distribution of these variables, 100 000 clinical trials were simulated for calculation of sample size required to reach sufficient power. For a treatment effect of 25% decrease in outcome variables, 50 patients were required in each arm using MSI compared to 93, 98, 120, 141, and 143 for MI size alone, hsTnT (area under the curve [AUC] and peak), and CKMB (AUC and peak) in order to reach a power of 90%. If average CMR scan day between treatment and control arms differed by 1 day, sample size needs to be increased by 54% (77 vs 50) to avoid scan day bias masking a treatment effect of 25%. Sample size in cardioprotection trials can be reduced 46% to 65% without compromising statistical power when using MSI by CMR as an outcome variable instead of MI size alone or biochemical markers. It is essential to ensure lack of bias in scan day between treatment and control arms to avoid compromising statistical power. © 2016 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.

Human respiratory syncytial virus load normalized by cell quantification as predictor of acute respiratory tract infection.

PubMed

Gómez-Novo, Miriam; Boga, José A; Álvarez-Argüelles, Marta E; Rojo-Alba, Susana; Fernández, Ana; Menéndez, María J; de Oña, María; Melón, Santiago

2018-05-01

Human respiratory syncytial virus (HRSV) is a common cause of respiratory infections. The main objective is to analyze the prediction ability of viral load of HRSV normalized by cell number in respiratory symptoms. A prospective, descriptive, and analytical study was performed. From 7307 respiratory samples processed between December 2014 to April 2016, 1019 HRSV-positive samples, were included in this study. Low respiratory tract infection was present in 729 patients (71.54%). Normalized HRSV load was calculated by quantification of HRSV genome and human β-globin gene and expressed as log10 copies/1000 cells. HRSV mean loads were 4.09 ± 2.08 and 4.82 ± 2.09 log10 copies/1000 cells in the 549 pharyngeal and 470 nasopharyngeal samples, respectively (P < 0.001). The viral mean load was 4.81 ± 1.98 log10 copies/1000 cells for patients under the age of 4-year-old (P < 0.001). The viral mean loads were 4.51 ± 2.04 cells in patients with low respiratory tract infection and 4.22 ± 2.28 log10 copies/1000 cells with upper respiratory tract infection or febrile syndrome (P < 0.05). A possible cut off value to predict LRTI evolution was tentatively established. Normalization of viral load by cell number in the samples is essential to ensure an optimal virological molecular diagnosis avoiding that the quality of samples affects the results. A high viral load can be a useful marker to predict disease progression. © 2018 Wiley Periodicals, Inc.

The Use of Dried Blood Spots for Pharmacokinetic Monitoring of Vemurafenib Treatment in Melanoma Patients.

PubMed

Nijenhuis, Cynthia M; Huitema, Alwin D R; Marchetti, Serena; Blank, Christian; Haanen, John B A G; van Thienen, Johannes V; Rosing, Hilde; Schellens, Jan H M; Beijnen, Jos H

2016-10-01

Pharmacokinetic monitoring is increasingly becoming an important part of clinical care of tyrosine kinase inhibitor treatment. Vemurafenib is an oral tyrosine kinase inhibitor that inhibits mutated serine/threonine protein kinase B-Raf (BRAF) and is approved for the treatment of adult patients with BRAF V600 mutation-positive unresectable or metastatic melanoma. The aim of this study was to establish the relationship between dried blood spot (DBS) and plasma concentrations of vemurafenib to enable the use of DBS sampling, which is a minimally invasive form of sample collection. In total, 43 paired plasma and DBS samples (in duplicate) were obtained from 8 melanoma patients on vemurafenib therapy and were analyzed using high-performance liquid chromatography-tandem mass spectrometry. Plasma concentrations were predicted from the DBS concentrations using 2 methods: (1) individual hematocrit correction and blood cell-to-plasma partitioning and (2) the calculated slope explaining the relationship between DBS and plasma concentrations (without individual hematocrit correction). Vemurafenib DBS concentrations and plasma concentrations showed a strong correlation (r = 0.964), and the relationship could be described by ([vemurafenib]plasma = [vemurafenib]DBS /0.64). The predicted plasma concentrations were within ±20% of the analyzed plasma concentrations in 97% and 100% of the samples for the methods with and without hematocrit correction, respectively. In conclusion, DBS concentrations and plasma concentrations of vemurafenib are highly correlated. Plasma concentrations can be predicted from DBS concentration using the blood cell-to-plasma partition and the average hematocrit value of this cohort (0.40 L/L). DBS sampling for pharmacokinetic monitoring of vemurafenib treatment can be used in clinical practice. © 2016, The American College of Clinical Pharmacology.

Sampling of Stochastic Input Parameters for Rockfall Calculations and for Structural Response Calculations Under Vibratory Ground Motion

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

M. Gross

2004-09-01

The purpose of this scientific analysis is to define the sampled values of stochastic (random) input parameters for (1) rockfall calculations in the lithophysal and nonlithophysal zones under vibratory ground motions, and (2) structural response calculations for the drip shield and waste package under vibratory ground motions. This analysis supplies: (1) Sampled values of ground motion time history and synthetic fracture pattern for analysis of rockfall in emplacement drifts in nonlithophysal rock (Section 6.3 of ''Drift Degradation Analysis'', BSC 2004 [DIRS 166107]); (2) Sampled values of ground motion time history and rock mechanical properties category for analysis of rockfall inmore » emplacement drifts in lithophysal rock (Section 6.4 of ''Drift Degradation Analysis'', BSC 2004 [DIRS 166107]); (3) Sampled values of ground motion time history and metal to metal and metal to rock friction coefficient for analysis of waste package and drip shield damage to vibratory motion in ''Structural Calculations of Waste Package Exposed to Vibratory Ground Motion'' (BSC 2004 [DIRS 167083]) and in ''Structural Calculations of Drip Shield Exposed to Vibratory Ground Motion'' (BSC 2003 [DIRS 163425]). The sampled values are indices representing the number of ground motion time histories, number of fracture patterns and rock mass properties categories. These indices are translated into actual values within the respective analysis and model reports or calculations. This report identifies the uncertain parameters and documents the sampled values for these parameters. The sampled values are determined by GoldSim V6.04.007 [DIRS 151202] calculations using appropriate distribution types and parameter ranges. No software development or model development was required for these calculations. The calculation of the sampled values allows parameter uncertainty to be incorporated into the rockfall and structural response calculations that support development of the seismic scenario for the Total System Performance Assessment for the License Application (TSPA-LA). The results from this scientific analysis also address project requirements related to parameter uncertainty, as specified in the acceptance criteria in ''Yucca Mountain Review Plan, Final Report'' (NRC 2003 [DIRS 163274]). This document was prepared under the direction of ''Technical Work Plan for: Regulatory Integration Modeling of Drift Degradation, Waste Package and Drip Shield Vibratory Motion and Seismic Consequences'' (BSC 2004 [DIRS 170528]) which directed the work identified in work package ARTM05. This document was prepared under procedure AP-SIII.9Q, ''Scientific Analyses''. There are no specific known limitations to this analysis.« less

Screening for Generalized Anxiety Disorder in inpatient psychosomatic rehabilitation: pathological worry and the impact of depressive symptoms

PubMed Central

Salzer, Simone; Stiller, Christian; Tacke-Pook, Achim; Jacobi, Claus; Leibing, Eric

2009-01-01

Objective: Pathological worry is considered to be a defining feature for Generalized Anxiety Disorder (GAD). The Penn State Worry Questionnaire (PSWQ) is an instrument for assessing pathological worry. Two earlier studies demonstrated the suitability of the PSWQ as screening instrument for GAD in outpatient and non-clinical samples. This study examined the suitability of the PSWQ as a screening instrument for GAD in a German inpatient sample (N=237). Furthermore, a comparison of patients with GAD and patients with depression and other anxiety disorders regarding pathological worry and depression was carried out in a sub-sample of N=118 patients. Method: Cut-off scores optimizing sensitivity, optimizing specificity and simultaneously optimizing both sensitivity and specificity were calculated for the PSWQ score by receiver operating characteristic analysis (ROC). Differences regarding pathological worry and depression measured by the PSWQ and the Beck Depression Inventory (BDI) across five diagnostic subgroups were examined by conducting one-way ANOVAs. The influence of depression on pathological worry was controlled by conducting an ANCOVA with BDI score as a covariate. Results: The ROC analysis showed an area under the curve of AUC=.67 (p=0.02) with only 54.4% of the patients correctly classified. Comparison of diagnostic subgroups showed that after controlling the influence of depression, differences referring to pathological worry between diagnostic subgroups no longer existed. Conclusions: Contrary to the earlier results we found that the use of the PSWQ as a screening instrument for GAD at least in a sample of psychotherapy inpatients is not meaningful. Instead of that, the PSWQ can be used to discriminate high from low worriers in clinical samples. Thus, the instrument can be useful in establishing e.g. symptom-oriented group interventions as they are established in behavioural-medicine inpatient settings. Furthermore, our findings stress the influence of (comorbid) depressive symptoms on the process of worrying. PMID:19742048

Screening for Generalized Anxiety Disorder in inpatient psychosomatic rehabilitation: pathological worry and the impact of depressive symptoms.

PubMed

Salzer, Simone; Stiller, Christian; Tacke-Pook, Achim; Jacobi, Claus; Leibing, Eric

2009-07-09

Pathological worry is considered to be a defining feature for Generalized Anxiety Disorder (GAD). The Penn State Worry Questionnaire (PSWQ) is an instrument for assessing pathological worry. Two earlier studies demonstrated the suitability of the PSWQ as screening instrument for GAD in outpatient and non-clinical samples. This study examined the suitability of the PSWQ as a screening instrument for GAD in a German inpatient sample (N=237). Furthermore, a comparison of patients with GAD and patients with depression and other anxiety disorders regarding pathological worry and depression was carried out in a sub-sample of N=118 patients. Cut-off scores optimizing sensitivity, optimizing specificity and simultaneously optimizing both sensitivity and specificity were calculated for the PSWQ score by receiver operating characteristic analysis (ROC). Differences regarding pathological worry and depression measured by the PSWQ and the Beck Depression Inventory (BDI) across five diagnostic subgroups were examined by conducting one-way ANOVAs. The influence of depression on pathological worry was controlled by conducting an ANCOVA with BDI score as a covariate. The ROC analysis showed an area under the curve of AUC=.67 (p=0.02) with only 54.4% of the patients correctly classified. Comparison of diagnostic subgroups showed that after controlling the influence of depression, differences referring to pathological worry between diagnostic subgroups no longer existed. Contrary to the earlier results we found that the use of the PSWQ as a screening instrument for GAD at least in a sample of psychotherapy inpatients is not meaningful. Instead of that, the PSWQ can be used to discriminate high from low worriers in clinical samples. Thus, the instrument can be useful in establishing e.g. symptom-oriented group interventions as they are established in behavioural-medicine inpatient settings. Furthermore, our findings stress the influence of (comorbid) depressive symptoms on the process of worrying.

In vitro adaptation of Plasmodium falciparum reveal variations in cultivability.

PubMed

White, John; Mascarenhas, Anjali; Pereira, Ligia; Dash, Rashmi; Walke, Jayashri T; Gawas, Pooja; Sharma, Ambika; Manoharan, Suresh Kumar; Guler, Jennifer L; Maki, Jennifer N; Kumar, Ashwani; Mahanta, Jagadish; Valecha, Neena; Dubhashi, Nagesh; Vaz, Marina; Gomes, Edwin; Chery, Laura; Rathod, Pradipsinh K

2016-01-22

Culture-adapted Plasmodium falciparum parasites can offer deeper understanding of geographic variations in drug resistance, pathogenesis and immune evasion. To help ground population-based calculations and inferences from culture-adapted parasites, the complete range of parasites from a study area must be well represented in any collection. To this end, standardized adaptation methods and determinants of successful in vitro adaption were sought. Venous blood was collected from 33 P. falciparum-infected individuals at Goa Medical College and Hospital (Bambolim, Goa, India). Culture variables such as whole blood versus washed blood, heat-inactivated plasma versus Albumax, and different starting haematocrit levels were tested on fresh blood samples from patients. In vitro adaptation was considered successful when two four-fold or greater increases in parasitaemia were observed within, at most, 33 days of attempted culture. Subsequently, parasites from the same patients, which were originally cryopreserved following blood draw, were retested for adaptability for 45 days using identical host red blood cells (RBCs) and culture media. At a new endemic area research site, ~65% of tested patient samples, with varied patient history and clinical presentation, were successfully culture-adapted immediately after blood collection. Cultures set up at 1% haematocrit and 0.5% Albumax adapted most rapidly, but no single test condition was uniformly fatal to culture adaptation. Success was not limited by low patient parasitaemia nor by patient age. Some parasites emerged even after significant delays in sample processing and even after initiation of treatment with anti-malarials. When 'day 0' cryopreserved samples were retested in parallel many months later using identical host RBCs and media, speed to adaptation appeared to be an intrinsic property of the parasites collected from individual patients. Culture adaptation of P. falciparum in a field setting is formally shown to be robust. Parasites were found to have intrinsic variations in adaptability to culture conditions, with some lines requiring longer attempt periods for successful adaptation. Quantitative approaches described here can help describe phenotypic diversity of field parasite collections with precision. This is expected to improve population-based extrapolations of findings from field-derived fresh culture-adapted parasites to broader questions of public health importance.

Time Courses of Inflammatory Markers after Aneurysmal Subarachnoid Hemorrhage and Their Possible Relevance for Future Studies.

PubMed

Höllig, Anke; Stoffel-Wagner, Birgit; Clusmann, Hans; Veldeman, Michael; Schubert, Gerrit A; Coburn, Mark

2017-01-01

Aneurysmal subarachnoid hemorrhage triggers an intense inflammatory response, which is suspected to increase the risk for secondary complications such as delayed cerebral ischemia (DCI). However, to date, the monitoring of the inflammatory response to detect secondary complications such as DCI has not become part of the clinical routine diagnostic. Here, we aim to illustrate the time courses of inflammatory parameters after aneurysmal subarachnoid hemorrhage (aSAH) and discuss the problems of inflammatory parameters as biomarkers but also their possible relevance for deeper understanding of the pathophysiology after aSAH and sophisticated planning of future studies. In this prospective cohort study, 109 patients with aSAH were initially included, n  = 28 patients had to be excluded. Serum and-if possible-cerebral spinal fluid samples ( n  = 48) were retrieved at days 1, 4, 7, 10, and 14 after aSAH. Samples were analyzed for leukocyte count and C-reactive protein (CRP) (serum samples only) as well as matrix metallopeptidase 9 (MMP9), intercellular adhesion molecule 1 (ICAM1), and leukemia inhibitory factor (LIF) [both serum and cerebrospinal fluid (CSF) samples]. Time courses of the inflammatory parameters were displayed and related to the occurrence of DCI. We illustrate the time courses of leukocyte count, CRP, MMP9, ICAM1, and LIF in patients' serum samples from the first until the 14th day after aSAH. Time courses of MMP9, ICAM1, and LIF in CSF samples are demonstrated. Furthermore, no significant difference was shown relating the time courses to the occurrence of DCI. We estimate that the wide range of the measured values hampers their interpretation and usage as a biomarker. However, understanding the inflammatory response after aSAH and generating a multicenter database may facilitate further studies: realistic sample size calculations on the basis of a multicenter database will increase the quality and clinical relevance of the acquired results.

Considering Spine Surgery: A Web-Based Calculator for Communicating Estimates of Personalized Treatment Outcomes.

PubMed

Moulton, Haley; Tosteson, Tor D; Zhao, Wenyan; Pearson, Loretta; Mycek, Kristina; Scherer, Emily; Weinstein, James N; Pearson, Adam; Abdu, William; Schwarz, Susan; Kelly, Michael; McGuire, Kevin; Milam, Alden; Lurie, Jon D

2018-06-05

Prospective evaluation of an informational web-based calculator for communicating estimates of personalized treatment outcomes. To evaluate the usability, effectiveness in communicating benefits and risks, and impact on decision quality of a calculator tool for patients with intervertebral disc herniations, spinal stenosis, and degenerative spondylolisthesis who are deciding between surgical and non-surgical treatments. The decision to have back surgery is preference-sensitive and warrants shared decision-making. However, more patient-specific, individualized tools for presenting clinical evidence on treatment outcomes are needed. Using Spine Patient Outcomes Research Trial (SPORT) data, prediction models were designed and integrated into a web-based calculator tool: http://spinesurgerycalc.dartmouth.edu/calc/. Consumer Reports subscribers with back-related pain were invited to use the calculator via email, and patient participants were recruited to use the calculator in a prospective manner following an initial appointment at participating spine centers. Participants completed questionnaires before and after using the calculator. We randomly assigned previously validated questions that tested knowledge about the treatment options to be asked either before or after viewing the calculator. 1,256 Consumer Reports subscribers and 68 patient participants completed the calculator and questionnaires. Knowledge scores were higher in the post-calculator group compared to the pre-calculator group, indicating that calculator usage successfully informed users. Decisional conflict was lower when measured following calculator use, suggesting the calculator was beneficial in the decision-making process. Participants generally found the tool helpful and easy to use. While the calculator is not a comprehensive decision aid, it does focus on communicating individualized risks and benefits for treatment options. Moreover, it appears to be helpful in achieving the goals of more traditional shared decision-making tools. It not only improved knowledge scores but also improved other aspects of decision quality.

A modified Wald interval for the area under the ROC curve (AUC) in diagnostic case-control studies

PubMed Central

2014-01-01

Background The area under the receiver operating characteristic (ROC) curve, referred to as the AUC, is an appropriate measure for describing the overall accuracy of a diagnostic test or a biomarker in early phase trials without having to choose a threshold. There are many approaches for estimating the confidence interval for the AUC. However, all are relatively complicated to implement. Furthermore, many approaches perform poorly for large AUC values or small sample sizes. Methods The AUC is actually a probability. So we propose a modified Wald interval for a single proportion, which can be calculated on a pocket calculator. We performed a simulation study to compare this modified Wald interval (without and with continuity correction) with other intervals regarding coverage probability and statistical power. Results The main result is that the proposed modified Wald intervals maintain and exploit the type I error much better than the intervals of Agresti-Coull, Wilson, and Clopper-Pearson. The interval suggested by Bamber, the Mann-Whitney interval without transformation and also the interval of the binormal AUC are very liberal. For small sample sizes the Wald interval with continuity has a comparable coverage probability as the LT interval and higher power. For large sample sizes the results of the LT interval and of the Wald interval without continuity correction are comparable. Conclusions If individual patient data is not available, but only the estimated AUC and the total sample size, the modified Wald intervals can be recommended as confidence intervals for the AUC. For small sample sizes the continuity correction should be used. PMID:24552686

A modified Wald interval for the area under the ROC curve (AUC) in diagnostic case-control studies.

PubMed

Kottas, Martina; Kuss, Oliver; Zapf, Antonia

2014-02-19

The area under the receiver operating characteristic (ROC) curve, referred to as the AUC, is an appropriate measure for describing the overall accuracy of a diagnostic test or a biomarker in early phase trials without having to choose a threshold. There are many approaches for estimating the confidence interval for the AUC. However, all are relatively complicated to implement. Furthermore, many approaches perform poorly for large AUC values or small sample sizes. The AUC is actually a probability. So we propose a modified Wald interval for a single proportion, which can be calculated on a pocket calculator. We performed a simulation study to compare this modified Wald interval (without and with continuity correction) with other intervals regarding coverage probability and statistical power. The main result is that the proposed modified Wald intervals maintain and exploit the type I error much better than the intervals of Agresti-Coull, Wilson, and Clopper-Pearson. The interval suggested by Bamber, the Mann-Whitney interval without transformation and also the interval of the binormal AUC are very liberal. For small sample sizes the Wald interval with continuity has a comparable coverage probability as the LT interval and higher power. For large sample sizes the results of the LT interval and of the Wald interval without continuity correction are comparable. If individual patient data is not available, but only the estimated AUC and the total sample size, the modified Wald intervals can be recommended as confidence intervals for the AUC. For small sample sizes the continuity correction should be used.

Patients Who Choose Primary Care Physicians Based On Low Office Visit Price Can Realize Broader Savings.

PubMed

Mehrotra, Ateev; Huckfeldt, Peter J; Haviland, Amelia M; Gascue, Laura; Sood, Neeraj

2016-12-01

Price transparency initiatives encourage patients to save money by choosing physicians with a relatively low price per office visit. Given that the price of such visits represents a small fraction of total spending, the extent of the savings from choosing such physicians has not been clear. Using a national sample of commercial claims data, we compared the care received by patients of high- and low-price primary care physicians. The median price for an established patient's office visit was $60 among low-price physicians and $86 among high-price physicians (price was calculated as reimbursement plus out-of-pocket spending). Patients of low-price physicians also received, on average, relatively low-price lab tests, imaging, and other procedures. Total spending per year among patients cared for by low-price physicians was $690 less than spending among patients cared for by high-price physicians. There were no consistent differences in patients' use of services between high- and low-price physicians. Despite modest differences in physicians' office visit prices, patients of low-price physicians had substantively lower overall spending, compared to patients of high-price physicians. Project HOPE—The People-to-People Health Foundation, Inc.

Does Council Tax Valuation Band (CTVB) correlate with Under-Privileged Area 8 (UPA8) score and could it be a better 'Jarman Index'?

PubMed Central

Beale, Norman; Taylor, Gordon; Straker-Cook, Dawn

2001-01-01

Background Widespread scepticism persists on the use of the Under-Privileged Area (UPA8) score of Jarman in distributing supplementary resources to so-attributed 'deprived' UK general practices. The search for better 'needs' markers continues. Having already shown that Council Tax Valuation Band (CTVB) is a predictor of UK GP workload, we compare, here, CTVB of residence of a random sample of patients with their respective 'Jarman' scores. Methods Correlation coefficient is calculated between (i) the CTVB of residence of a randomised sample of patients from an English general practice and (ii) the UPA8 scores of the relevant enumeration districts in which they live. Results There is a highly significant correlation between the two measures despite modest study size of 478 patients (85% response). Conclusions The proposal that CTVB is a marker of deprivation and of clinical demand should be examined in more detail: it correlates with 'Jarman', which is already used in NHS resource allocation. But unlike 'Jarman', CTVB is simple, objective, and free of the problems of Census data. CTVB, being household-based, can be aggregated at will. PMID:11716793

Does Council Tax Valuation Band (CTVB) correlate with Under-Privileged Area 8 (UPA8) score and could it be a better 'Jarman Index'?

PubMed

Beale, N; Taylor, G; Straker-Cook, D

2001-01-01

Widespread scepticism persists on the use of the Under-Privileged Area (UPA8) score of Jarman in distributing supplementary resources to so-attributed 'deprived' UK general practices. The search for better 'needs' markers continues. Having already shown that Council Tax Valuation Band (CTVB) is a predictor of UK GP workload, we compare, here, CTVB of residence of a random sample of patients with their respective 'Jarman' scores. Correlation coefficient is calculated between (i) the CTVB of residence of a randomised sample of patients from an English general practice and (ii) the UPA8 scores of the relevant enumeration districts in which they live. There is a highly significant correlation between the two measures despite modest study size of 478 patients (85% response). The proposal that CTVB is a marker of deprivation and of clinical demand should be examined in more detail: it correlates with 'Jarman', which is already used in NHS resource allocation. But unlike 'Jarman', CTVB is simple, objective, and free of the problems of Census data. CTVB, being household-based, can be aggregated at will.

Survival analysis of patients with esophageal cancer using parametric cure model.

PubMed

Rasouli, Mahboube; Ghadimi, Mahmood Reza; Mahmoodi, Mahmood; Mohammad, Kazem; Zeraati, Hojjat; Hosseini, Mostafa

2011-01-01

Esophageal cancer is a major cause of mortality and morbidity in the Caspian littoral north-eastern part of Iran. The aim of this study was to calculate cure function as well as to identify the factors that are related to this function among patients with esophageal cancer in this geographical area. Three hundred fifty nine cases of esophageal cancer registered in the Babol cancer registry during the period of 1990 to 1991 (inclusive) were followed up for 15 years up to 2006. Parametric cure model was used to calculate cure fraction and investigate the factors responsible for probability of cure among patients. Sample of subjects encompassed 62.7% men and 37.3% women, with mean ages of diagnosis was 60.0 and 55.3 years, respectively. The median survival time reached about 9 months and estimated survival rates in 1, 3, and 5 years following diagnosis were 23%, 15% and 13%, respectively. Results show the family history affects the cured fraction independently of its effect on early outcome and has a significant effect on the probability of uncured. The average cure fraction was estimated to be 0.10. As the proportionality assumption of Cox model does not meet in certain circumstances, a parametric cure model can provide a better fit and a better description of survival related outcome.

The ADOPT-LC score: a novel predictive index of in-hospital mortality of cirrhotic patients following surgical procedures, based on a national survey.

PubMed

Sato, Masaya; Tateishi, Ryosuke; Yasunaga, Hideo; Horiguchi, Hiromasa; Matsui, Hiroki; Yoshida, Haruhiko; Fushimi, Kiyohide; Koike, Kazuhiko

2017-03-01

We aimed to develop a model for predicting in-hospital mortality of cirrhotic patients following major surgical procedures using a large sample of patients derived from a Japanese nationwide administrative database. We enrolled 2197 cirrhotic patients who underwent elective (n = 1973) or emergency (n = 224) surgery. We analyzed the risk factors for postoperative mortality and established a scoring system for predicting postoperative mortality in cirrhotic patients using a split-sample method. In-hospital mortality rates following elective or emergency surgery were 4.7% and 20.5%, respectively. In multivariate analysis, patient age, Child-Pugh (CP) class, Charlson Comorbidity Index (CCI), and duration of anesthesia in elective surgery were significantly associated with in-hospital mortality. In emergency surgery, CP class and duration of anesthesia were significant factors. Based on multivariate analysis in the training set (n = 987), the Adequate Operative Treatment for Liver Cirrhosis (ADOPT-LC) score that used patient age, CP class, CCI, and duration of anesthesia to predict in-hospital mortality following elective surgery was developed. This scoring system was validated in the testing set (n = 986) and produced an area under the curve of 0.881. We also developed iOS/Android apps to calculate ADOPT-LC scores to allow easy access to the current evidence in daily clinical practice. Patient age, CP class, CCI, and duration of anesthesia were identified as important risk factors for predicting postoperative mortality in cirrhotic patients. The ADOPT-LC score effectively predicts in-hospital mortality following elective surgery and may assist decisions regarding surgical procedures in cirrhotic patients based on a quantitative risk assessment. © 2016 The Authors Hepatology Research published by John Wiley & Sons Australia, Ltd on behalf of Japan Society of Hepatology.

Abundance of Enterobacteriaceae in the colon mucosa in diverticular disease

PubMed Central

Linninge, Caroline; Roth, Bodil; Erlanson-Albertsson, Charlotte; Molin, Göran; Toth, Ervin; Ohlsson, Bodil

2018-01-01

AIM To compare gut bacterial diversity and amount of Enterobacteriaceae in colonic mucosa between patients with and without diverticular disease (DD). METHODS Patients in a stable clinical condition with planned elective colonoscopy were included. Blood samples and colon mucosa biopsies were collected at the colonoscopy. Study questionnaires including questions about gastrointestinal symptoms were completed by the patients and physicians. DNA from mucosa samples was isolated and the amount of Enterobacteriaceae was estimated using PCR assay. Terminal restriction fragment length polymorphism was applied to assess microbial diversity. Diversity was estimated by calculations of richness (number of terminal restriction fragments) and Shannon-Wiener and Simpson’s indices. RESULTS A total of 51 patients were included, 16 patients with DD [68 (62-76) years] and 35 controls [62 (40-74) years] without any diverticula. Patients with DD had significantly higher levels of Enterobacteriaceae than those without DD (P = 0.043), and there was an inverse relationship between the amount of Enterobacteriaceae and the Simpson’s index (rs = -0.361, P = 0.033) and the Shannon-Wiener index (rs = -0.299, P = 0.081). The Simpson’s index (P = 0.383), Shannon-Wiener index (P = 0.401) or number of restrictions fragments (P = 0.776) did not differ between DD and controls. The majority of patients experienced gastrointestinal symptoms, and 22 patients (43.1%) fulfilled the criteria for irritable bowel syndrome, with no difference between the groups (P = 0.212). Demography, socioeconomic status, lifestyle habits, inflammatory biomarkers, or symptoms were not related to the amount of Enterobacteriaceae or bacterial diversity. CONCLUSION Patients with DD had higher amount of Enterobacteriaceae in the colon mucosa compared to patients without diverticula. PMID:29487763

Screening tests for Chlamydia trachomatis or Neisseria gonorrhoeae using the cobas 4800 PCR system do not require a second test to confirm: an audit of patients issued with equivocal results at a sexual health clinic in the Northwest of England, U.K.

PubMed

Hopkins, Mark J; Smith, Godfrey; Hart, Ian J; Alloba, Fath

2012-11-01

To assess the clinical utility of supplementary PCRs following a positive cobas 4800 CT/NG PCR screening test result. Laboratory reports, for Chlamydia trachomatis or Neisseria gonorrhoeae, issued to genitourinary medicine patients between April 2010 and April 2011 were reviewed retrospectively. Positive reports were routinely confirmed by supplementary PCRs and N gonorrhoeae culture. Clinical records of patients with unconfirmed positive (equivocal) reports were retrieved to determine if the infection was confirmed by a second sample obtained at patient recall and the impact of this process on antibiotic management. Over 15 000 patients were tested during the study period. The prevalence of chlamydia and gonorrhoea was 972 (5.75%) and 76 (0.50%), respectively. A further 78 chlamydia and 2 gonorrhoea equivocal reports were issued. Only 56 (72%) patients with an equivocal chlamydia report returned to the clinic, and of these, only 41 (73%) gave a second sample to retest. Positive predictive value (PPV) of the PCR screening test was calculated at 98.0% and 97.5% for detection of chlamydia infection from urine and rectal swabs, respectively. Most patients accepted antibiotic treatment before their infection status had been confirmed. Prevalence of gonorrhoea infection was low but the PPV of the screening PCR in urine specimens remained high (98.75%). Equivocal reports introduce delays to patient management, while the risk of unnecessary antibiotic therapy appears acceptable to most patients. The cobas 4800 CT/NG PCR screening assay can achieve UK testing standards (PPV >90%) for chlamydia, and low prevalence gonorrhoea in urine without supplementary tests. A patient-led confirmation algorithm is proposed.

Osimertinib in patients with epidermal growth factor receptor T790M advanced non-small cell lung cancer selected using cytology samples.

PubMed

Kiura, Katsuyuki; Yoh, Kiyotaka; Katakami, Nobuyuki; Nogami, Naoyuki; Kasahara, Kazuo; Takahashi, Toshiaki; Okamoto, Isamu; Cantarini, Mireille; Hodge, Rachel; Uchida, Hirohiko

2018-04-01

Osimertinib is a potent, irreversible epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) selective for EGFR-TKI sensitizing (EGFRm) and T790M resistance mutations. The primary objective of the cytology cohort in the AURA study was to investigate safety and efficacy of osimertinib in pretreated Japanese patients with EGFR T790M mutation-positive non-small cell lung cancer (NSCLC), with screening EGFR T790M mutation status determined from cytology samples. The cytology cohort was included in the Phase I dose expansion component of the AURA study. Patients were enrolled based on a positive result of T790M by using cytology samples, and received osimertinib 80 mg in tablet form once daily until disease progression or until clinical benefit was no longer observed at the discretion of the investigator. Primary endpoint for efficacy was objective response rate (ORR) by investigator assessment. Twenty-eight Japanese patients were enrolled into the cytology cohort. At data cut-off (February 1, 2016), 12 (43%) were on treatment. Investigator-assessed ORR was 75% (95% confidence interval [CI] 55, 89) and median duration of response was 9.7 months (95% CI 3.8, not calculable [NC]). Median progression-free survival was 8.3 months (95% CI 4.2, NC) and disease control rate was 96% (95% CI 82, 100). The most common all-causality adverse events were paronychia (46%), dry skin (46%), diarrhea (36%) and rash (36%). Osimertinib provided clinical benefit with a manageable safety profile in patients with pretreated EGFR T790M mutation-positive NSCLC whose screening EGFR T790M mutation-positive status was determined from cytology samples. (ClinicalTrials.gov number NCT01802632). © 2018 The Authors. Cancer Science published by John Wiley & Sons Australia, Ltd on behalf of Japanese Cancer Association.

The incidence of hoarseness after mediastinoscopy and outcome of video-assisted versus conventional mediastinoscopy in lung cancer staging.

PubMed

Sayar, Adnan; Çitak, Necati; Büyükkale, Songül; Metin, Muzaffer; Kök, Abdulaziz; Çelikten, Alper; Gürses, Atilla

2016-02-01

Objectives Theoretically, video-assisted mediastinoscopy (VM) should provide a decrease in the incidence of hoarseness in comparison with conventional mediastinoscopy (CM). Methods An investigation of 448 patients with the NSCLC who underwent mediastinoscopy (n = 261 VM, n = 187 CM) between 2006 and 2010. Results With VM, the mean number of sampled LNs and of stations per case were both significantly higher (n = 7.91 ± 1.97 and n = 4.29 ± 0.81) than they were for CM (n = 6.65 ± 1.79 and n = 4.14 ± 0.84) (p < 0.001 and p = 0.06). Hoarseness was reported in 24 patients (5.4%) with VM procedures resulting in a higher incidence of hoarseness than did CM procedures (6.9% and 3.2%) (p = 0.08). The incidence of hoarseness was observed to be more frequent in patients with left-lung carcinoma who had undergone a mediastinoscopy (p = 0.03). Hoarseness developed in 6% of the patients sampled at station 4L, whereas this ratio was 0% in patients who were not sampled at 4L (p = 0.07). A multivariate analysis showed that the presence of a tumor in the left lung is the only independent risk factor indicating hoarseness (p = 0.09). The sensitivity, NPV, and accuracy of VM were calculated as to be 0.87, 0.95, and 0.96, respectively. The same staging values for CM were 0.83, 0.94, and 0.95, respectively. Conclusion VM, the presence of a tumor in the left-lung, and 4L sampling via mediastinoscopy are risk factors for subsequent hoarseness. Probably due to a wider area of dissection, VM can lead to more frequent hoarseness.

[Statistical Process Control (SPC) can help prevent treatment errors without increasing costs in radiotherapy].

PubMed

Govindarajan, R; Llueguera, E; Melero, A; Molero, J; Soler, N; Rueda, C; Paradinas, C

2010-01-01

Statistical Process Control (SPC) was applied to monitor patient set-up in radiotherapy and, when the measured set-up error values indicated a loss of process stability, its root cause was identified and eliminated to prevent set-up errors. Set up errors were measured for medial-lateral (ml), cranial-caudal (cc) and anterior-posterior (ap) dimensions and then the upper control limits were calculated. Once the control limits were known and the range variability was acceptable, treatment set-up errors were monitored using sub-groups of 3 patients, three times each shift. These values were plotted on a control chart in real time. Control limit values showed that the existing variation was acceptable. Set-up errors, measured and plotted on a X chart, helped monitor the set-up process stability and, if and when the stability was lost, treatment was interrupted, the particular cause responsible for the non-random pattern was identified and corrective action was taken before proceeding with the treatment. SPC protocol focuses on controlling the variability due to assignable cause instead of focusing on patient-to-patient variability which normally does not exist. Compared to weekly sampling of set-up error in each and every patient, which may only ensure that just those sampled sessions were set-up correctly, the SPC method enables set-up error prevention in all treatment sessions for all patients and, at the same time, reduces the control costs. Copyright © 2009 SECA. Published by Elsevier Espana. All rights reserved.

Profound loss of neprilysin accompanied by decreased levels of neuropeptides and increased CRP in ulcerative colitis

PubMed Central

Sargın, Zeynep Gök; Tazegul, Gokhan; Elpek, Gülsüm Özlem; Yıldırım, Bülent

2017-01-01

Neprilysin (NEP, CD10) acts to limit excessive inflammation partly by hydrolyzing neuropeptides. Although deletion of NEP exacerbates intestinal inflammation in animal models, its role in ulcerative colitis (UC) is not well explored. Herein, we aimed to demonstrate changes in NEP and associated neuropeptides at the same time in colonic tissue. 72 patients with UC and 27 control patients were included. Patients’ demographic data and laboratory findings, five biopsy samples from active colitis sites and five samples from uninvolved mucosa were collected. Substance P (SP), calcitonin gene related peptide (CGRP) and vasoactive intestinal peptide (VIP) were extracted from freshly frozen tissues and measured using ELISA. Levels of NEP expression were determined using immunohistochemistry and immunoreactivity scores were calculated. GEBOES grading system was also used. We demonstrated a profound loss (69.4%) of NEP expression in UC, whereas all healthy controls had NEP expression. Patients with UC had lower neuronal SP; however non-neuronal SP remained similar. UC patients had also lower neuronal and non-neuronal VIP levels. CGRP were low in general and no significant changes were observed. Additionally, CRP positive patients with UC had higher rates of NEP loss (80% vs 51.9%) and lower SP levels when compared with CRP negative patients with UC. Concurrent decreases in SP and VIP with profound loss of NEP expression observed in UC is likely to be one of the factors in pathogenesis. Further studies are required to define the role of neuropeptides and NEP in UC. PMID:29232715

Prevalence of Mild Cognitive Impairment and Dementia in Saudi Arabia: A Community-Based Study.

PubMed

Alkhunizan, Muath; Alkhenizan, Abdullah; Basudan, Loay

2018-01-01

The age of the population in Saudi Arabia is shifting toward elderly, which can lead to an increased risk of mild cognitive impairment (MCI) and dementia. The aim of this study is to determine the prevalence of cognitive impairment (MCI and dementia) among elderly patients in a community-based setting in Riyadh, Saudi Arabia. In this cross-sectional study, we included patients aged 60 years and above who were seen in the Family Medicine Clinics affiliated with King Faisal Specialist Hospital and Research Centre. Patients with delirium, active depression, and patients with a history of severe head trauma in the past 3 months were excluded. Patients were interviewed during their regular visit by a trained physician to collect demographic data and to administer the validated Arabic version of the Montreal Cognitive Assessment (MoCA) test. One hundred seventy-one Saudi patients were recruited based on a calculated sample size for the aim of this study. The mean age of included sample was 67 ± 6 years. The prevalence of cognitive impairment was 45%. The prevalence of MCI was 38.6% and the prevalence of dementia was 6.4%. Age, low level of education, hypertension, and cardiovascular disease were risk factors for cognitive impairment. Prevalence of MCI and dementia in Saudi Arabia using MoCA were in the upper range compared to developed and developing countries. The high rate of risk factors for cognitive impairment in Saudi Arabia is contributing to this finding.

[Formal sample size calculation and its limited validity in animal studies of medical basic research].

PubMed

Mayer, B; Muche, R

2013-01-01

Animal studies are highly relevant for basic medical research, although their usage is discussed controversially in public. Thus, an optimal sample size for these projects should be aimed at from a biometrical point of view. Statistical sample size calculation is usually the appropriate methodology in planning medical research projects. However, required information is often not valid or only available during the course of an animal experiment. This article critically discusses the validity of formal sample size calculation for animal studies. Within the discussion, some requirements are formulated to fundamentally regulate the process of sample size determination for animal experiments.

[Use of topical non-steroidal anti-inflammatory agents in an urban health center. Comparison with the current evidence].

PubMed

Yagüe-Sebastián, M M; Coscollar-Escartín, I; Muñoz-Albadalejo, P; López-Canales, M C; Villaverde-Royo, M V; Gutiérrez-Moreno, F

2013-09-01

To describe the prescribing of topical non-steroidal anti-inflammatory drugs (NSAIDs) in an urban health center (Zaragoza, Spain). A cross-sectional descriptive study was conducted on subjects who belonged to an urban center and were studied during the year 2010. The sample size with a confidence level of 95%, was calculated, a total of 843 prescriptions were analyzed. The sample was single random, and 150 cases were selected. The prevalence and confidence intervals were calculated. The statistical package STATA 9.1 was used for the calculations. The most used drug was diclofenac, in 27.33% (95% CI: 20.65-34.88). NSAIDs were most used in females. In 18% of the cases the area of application was the knee, followed by the 15% in the lower back area (95% CI: 10,22-21,78). There were no adverse reactions. Frequent use is made of topical NSAIDs in a basic health area. Current recommendations support the use in the knee and in the hand, but not in the back, where its use is common. The use of topical NSAIDs decreases side effects and drug interactions, therefore their use is recommended in patients on multiple drug therapy and in the elderly. Copyright © 2012 Sociedad Española de Médicos de Atención Primaria (SEMERGEN). Publicado por Elsevier España. All rights reserved.

A new approach to integrate GPU-based Monte Carlo simulation into inverse treatment plan optimization for proton therapy.

PubMed

Li, Yongbao; Tian, Zhen; Song, Ting; Wu, Zhaoxia; Liu, Yaqiang; Jiang, Steve; Jia, Xun

2017-01-07

Monte Carlo (MC)-based spot dose calculation is highly desired for inverse treatment planning in proton therapy because of its accuracy. Recent studies on biological optimization have also indicated the use of MC methods to compute relevant quantities of interest, e.g. linear energy transfer. Although GPU-based MC engines have been developed to address inverse optimization problems, their efficiency still needs to be improved. Also, the use of a large number of GPUs in MC calculation is not favorable for clinical applications. The previously proposed adaptive particle sampling (APS) method can improve the efficiency of MC-based inverse optimization by using the computationally expensive MC simulation more effectively. This method is more efficient than the conventional approach that performs spot dose calculation and optimization in two sequential steps. In this paper, we propose a computational library to perform MC-based spot dose calculation on GPU with the APS scheme. The implemented APS method performs a non-uniform sampling of the particles from pencil beam spots during the optimization process, favoring those from the high intensity spots. The library also conducts two computationally intensive matrix-vector operations frequently used when solving an optimization problem. This library design allows a streamlined integration of the MC-based spot dose calculation into an existing proton therapy inverse planning process. We tested the developed library in a typical inverse optimization system with four patient cases. The library achieved the targeted functions by supporting inverse planning in various proton therapy schemes, e.g. single field uniform dose, 3D intensity modulated proton therapy, and distal edge tracking. The efficiency was 41.6  ±  15.3% higher than the use of a GPU-based MC package in a conventional calculation scheme. The total computation time ranged between 2 and 50 min on a single GPU card depending on the problem size.

A new approach to integrate GPU-based Monte Carlo simulation into inverse treatment plan optimization for proton therapy

NASA Astrophysics Data System (ADS)

Li, Yongbao; Tian, Zhen; Song, Ting; Wu, Zhaoxia; Liu, Yaqiang; Jiang, Steve; Jia, Xun

2017-01-01

Monte Carlo (MC)-based spot dose calculation is highly desired for inverse treatment planning in proton therapy because of its accuracy. Recent studies on biological optimization have also indicated the use of MC methods to compute relevant quantities of interest, e.g. linear energy transfer. Although GPU-based MC engines have been developed to address inverse optimization problems, their efficiency still needs to be improved. Also, the use of a large number of GPUs in MC calculation is not favorable for clinical applications. The previously proposed adaptive particle sampling (APS) method can improve the efficiency of MC-based inverse optimization by using the computationally expensive MC simulation more effectively. This method is more efficient than the conventional approach that performs spot dose calculation and optimization in two sequential steps. In this paper, we propose a computational library to perform MC-based spot dose calculation on GPU with the APS scheme. The implemented APS method performs a non-uniform sampling of the particles from pencil beam spots during the optimization process, favoring those from the high intensity spots. The library also conducts two computationally intensive matrix-vector operations frequently used when solving an optimization problem. This library design allows a streamlined integration of the MC-based spot dose calculation into an existing proton therapy inverse planning process. We tested the developed library in a typical inverse optimization system with four patient cases. The library achieved the targeted functions by supporting inverse planning in various proton therapy schemes, e.g. single field uniform dose, 3D intensity modulated proton therapy, and distal edge tracking. The efficiency was 41.6  ±  15.3% higher than the use of a GPU-based MC package in a conventional calculation scheme. The total computation time ranged between 2 and 50 min on a single GPU card depending on the problem size.

A New Approach to Integrate GPU-based Monte Carlo Simulation into Inverse Treatment Plan Optimization for Proton Therapy

PubMed Central

Li, Yongbao; Tian, Zhen; Song, Ting; Wu, Zhaoxia; Liu, Yaqiang; Jiang, Steve; Jia, Xun

2016-01-01

Monte Carlo (MC)-based spot dose calculation is highly desired for inverse treatment planning in proton therapy because of its accuracy. Recent studies on biological optimization have also indicated the use of MC methods to compute relevant quantities of interest, e.g. linear energy transfer. Although GPU-based MC engines have been developed to address inverse optimization problems, their efficiency still needs to be improved. Also, the use of a large number of GPUs in MC calculation is not favorable for clinical applications. The previously proposed adaptive particle sampling (APS) method can improve the efficiency of MC-based inverse optimization by using the computationally expensive MC simulation more effectively. This method is more efficient than the conventional approach that performs spot dose calculation and optimization in two sequential steps. In this paper, we propose a computational library to perform MC-based spot dose calculation on GPU with the APS scheme. The implemented APS method performs a non-uniform sampling of the particles from pencil beam spots during the optimization process, favoring those from the high intensity spots. The library also conducts two computationally intensive matrix-vector operations frequently used when solving an optimization problem. This library design allows a streamlined integration of the MC-based spot dose calculation into an existing proton therapy inverse planning process. We tested the developed library in a typical inverse optimization system with four patient cases. The library achieved the targeted functions by supporting inverse planning in various proton therapy schemes, e.g. single field uniform dose, 3D intensity modulated proton therapy, and distal edge tracking. The efficiency was 41.6±15.3% higher than the use of a GPU-based MC package in a conventional calculation scheme. The total computation time ranged between 2 and 50 min on a single GPU card depending on the problem size. PMID:27991456

Evaluation of standardized and applied variables in predicting treatment outcomes of polytrauma patients.

PubMed

Aksamija, Goran; Mulabdic, Adi; Rasic, Ismar; Muhovic, Samir; Gavric, Igor

2011-01-01

Polytrauma is defined as an injury where they are affected by at least two different organ systems or body, with at least one life-threatening injuries. Given the multilevel model care of polytrauma patients within KCUS are inevitable weaknesses in the management of this category of patients. To determine the dynamics of existing procedures in treatment of polytrauma patients on admission to KCUS, and based on statistical analysis of variables applied to determine and define the factors that influence the final outcome of treatment, and determine their mutual relationship, which may result in eliminating the flaws in the approach to the problem. The study was based on 263 polytrauma patients. Parametric and non-parametric statistical methods were used. Basic statistics were calculated, based on the calculated parameters for the final achievement of research objectives, multicoleration analysis, image analysis, discriminant analysis and multifactorial analysis were used. From the universe of variables for this study we selected sample of n = 25 variables, of which the first two modular, others belong to the common measurement space (n = 23) and in this paper defined as a system variable methods, procedures and assessments of polytrauma patients. After the multicoleration analysis, since the image analysis gave a reliable measurement results, we started the analysis of eigenvalues, that is defining the factors upon which they obtain information about the system solve the problem of the existing model and its correlation with treatment outcome. The study singled out the essential factors that determine the current organizational model of care, which may affect the treatment and better outcome of polytrauma patients. This analysis has shown the maximum correlative relationships between these practices and contributed to development guidelines that are defined by isolated factors.

Healthcare costs and resource utilization of asthma in Germany: a claims data analysis.

PubMed

Jacob, Christian; Bechtel, Benno; Engel, Susanne; Kardos, Peter; Linder, Roland; Braun, Sebastian; Greiner, Wolfgang

2016-03-01

Asthma is associated with a substantial economic burden on the German Statutory Health Insurance. To determine costs and resource utilization associated with asthma and to analyze the impact of disease severity on subgroups based on age and gender. A claims database analysis from the statutory health insurance perspective was conducted. Patients with an ICD-10-GM code of asthma were extracted from a 10% sample of a large German sickness fund. Five controls for each asthma patient matched by age and gender were randomly selected from the same database. Costs and resource utilization were calculated for each individual in the asthma and control group. Incremental asthma-related costs were calculated as the mean cost difference. Based on prescribed asthma medication, patients were classified as intermittent or persistent. In addition, age groups of ≤ 5, 6-18, and >18 years were analyzed separately and gender differences were investigated. Overall, 49,668 individuals were included in the asthma group. On average, total annual costs per patient were €753 higher (p = 0.000) compared to the control group (€2,168 vs. €1,415). Asthma patients had significantly higher (p = 0.000) outpatient (€217), inpatient (€176), and pharmacy costs (€259). Incremental asthma-related total costs were higher for patients with persistent asthma compared to patients with intermittent asthma (€1,091 vs. €408). Women aged >18 years with persistent asthma had the highest difference in costs compared to their controls (€1,207; p < 0.0001). Corresponding healthcare resource utilization was significantly higher in the asthma group (p = 0.000). The treatment of asthma is associated with an increased level of healthcare resource utilization and significantly higher healthcare costs. Asthma imposes a substantial economic burden on sickness funds.

Nutritional status and adequacy of enteral nutrition in pediatric cancer patients at a reference center in northeastern Brazil.

PubMed

Maciel Barbosa, J; Pedrosa, F; Coelho Cabral, P

2012-01-01

Individualized nutritional support is important to pediatric cancer patients and should be integrated to the overall treatment of these patients. Analyze the nutritional status of cancer patients submitted to enteral nutrition (EN) and assess the adequacy of this form of nutrition. A case series study was carried out at the Pediatric Oncology Unit of the Institute of Integrative Medicine Professor Fernando Figueira (IMIP, Brazil, Recife-PE) between January and December 2009. Clinical and anthropometric data were obtained from medical charts and nutritional follow-up charts. Z scores for height for age, weight for age and body mass index for age indicators (H/A, W/A and BMI/A, respectively) were calculated using the AnthroPlus program. Caloric and protein requirements were calculated based on the recommendations of the Brazilian National Council of Oncologic Nutrition. At the beginning of EN, 32.4% of the sample had short stature and 23.9% were underweight based on the BMI/A indicator. The assessment of EN adequacy demonstrated that 49.3% reached the caloric requirements and 76.1% reached the protein requirements, with maximal intakes of 65.6 Kcal/Kg/day and 1.95 g of protein/kg/day. Malnourished patients had greater mean Z scores for W/A and BMI/A at the end of EN, whereas no significant changes were found among patients with adequate nutritional status and significant reductions in these indicators were found among those with overweight or obesity. The patients either maintained or achieved a significant improvement in nutritional status, which demonstrates the importance of nutritional support and follow up during hospitalization.

Association of Antidementia Drugs and Mortality in Community-Dwelling Frail Older Patients With Dementia: The Role of Mortality Risk Assessment.

PubMed

Pilotto, Alberto; Polidori, Maria Cristina; Veronese, Nicola; Panza, Francesco; Arboretti Giancristofaro, Rosa; Pilotto, Andrea; Daragjati, Julia; Carrozzo, Eleonora; Prete, Camilla; Gallina, Pietro; Padovani, Alessandro; Maggi, Stefania

2018-02-01

To evaluate whether treatment with antidementia drugs is associated with reduced mortality in older patients with different mortality risk at baseline. Retrospective. Community-dwelling. A total of 6818 older people who underwent a Standardized Multidimensional Assessment Schedule for Adults and Aged Persons (SVaMA) evaluation to determine accessibility to homecare services or nursing home admission from 2005 to 2013 in the Padova Health District, Italy were included. Mortality risk at baseline was calculated by the Multidimensional Prognostic Index (MPI), based on information collected with the SVaMA. Participants were categorized to have mild (MPI-SVaMA-1), moderate (MPI-SVaMA-2), and high (MPI-SVaMA-3) mortality risk. Propensity score-adjusted hazard ratios (HR) of 2-year mortality were calculated according to antidementia drug treatment. Patients treated with antidementia drugs had a significant lower risk of death than untreated patients (HR 0.82; 95% confidence interval [CI] 0.73-0.92 and 0.56; 95% CI 0.49-0.65 for patients treated less than 2 years and more than 2 years treatment, respectively). After dividing patients according to their MPI-SVaMA grade, antidementia treatment was significantly associated with reduced mortality in the MPI-SVaMA-1 mild (HR 0.71; 95% CI 0.54-0.92) and MPI-SVaMA-2 moderate risk (HR 0.61; 95% CI 0.40-0.91, matched sample), but not in the MPI-SVaMA-3 high risk of death. This large community-dwelling patient study suggests that antidementia drugs might contribute to increased survival in older adults with dementia with lower mortality risk. Copyright © 2017 AMDA – The Society for Post-Acute and Long-Term Care Medicine. Published by Elsevier Inc. All rights reserved.

The effect of a new lifetime-cardiovascular-risk display on patients' motivation to participate in shared decision-making.

PubMed

Jegan, Nikita Roman A; Kürwitz, Sarah Anna; Kramer, Lena Kathrin; Heinzel-Gutenbrunner, Monika; Adarkwah, Charles Christian; Popert, Uwe; Donner-Banzhoff, Norbert

2018-06-09

This study investigated the effects of three different risk displays used in a cardiovascular risk calculator on patients' motivation for shared decision-making (SDM). We compared a newly developed time-to-event (TTE) display with two established absolute risk displays (i.e. emoticons and bar charts). The accessibility, that is, how understandable, helpful, and trustworthy patients found each display, was also investigated. We analysed a sample of 353 patients recruited in general practices. After giving consent, patients were introduced to one of three fictional vignettes with low, medium or high cardiovascular risk. All three risk displays were shown in a randomized order. Patients were asked to rate each display with regard to motivation for SDM and accessibility. Two-factorial repeated measures analyses of variance were conducted to compare the displays and investigate possible interactions with age. Regarding motivation for SDM, the TTE elicited the highest motivation, followed by the emoticons and bar chart (p < .001). The displays had no differential influence on the age groups (p = .445). While the TTE was generally rated more accessible than the emoticons and bar chart (p < .001), the emoticons were only superior to the bar chart in the younger subsample. However, this was only to a small effect (interaction between display and age, p < .01, η 2  = 0.018). Using fictional case vignettes, the novel TTE display was superior regarding motivation for SDM and accessibility when compared to established displays using emoticons and a bar chart. If future research can replicate these results in real-life consultations, the TTE display will be a valuable addition to current risk calculators and decision aids by improving patients' participation.

Night sleep electroencephalogram power spectral analysis in excessive daytime sleepiness disorders.

PubMed

Reimão, R

1991-06-01

A group of 53 patients (40 males, 13 females) with mean age of 49 years, ranging from 30 to 70 years, was evaluated in the following excessive daytime sleepiness (EDS) disorders: obstructive sleep apnea syndrome (B4a), periodic movements in sleep (B5a), affective disorder (B2a), functional psychiatric non affective disorder (B2b). We considered all adult patients referred to the Center sequentially with no other distinctions but these three criteria: (a) EDS was the main complaint; (b) right handed; (c) not using psychotropic drugs for two weeks prior to the all-night polysomnography. EEG (C3/A1, C4/A2) samples from 2 to 10 minutes of each stage of the first REM cycle were chosen. The data was recorded simultaneously in magnetic tape and then fed into a computer for power spectral analysis. The percentage of power (PP) in each band calculated in relation to the total EEG power was determined of subsequent sections of 20.4 s for the following frequency bands: delta, theta, alpha and beta. The PP in all EDS patients sample had a tendency to decrease progressively from the slowest to the fastest frequency bands, in every sleep stage. PP distribution in the delta range increased progressively from stage 1 to stage 4; stage REM levels were close to stage 2 levels. In an EDS patients interhemispheric coherence was high in every band and sleep stage. B4a patients sample PP had a tendency to decrease progressively from the slowest to the fastest frequency bands, in every sleep stage; PP distribution in the delta range increased progressively from stage 1 to stage 4; stage REM levels were between stage 1 and stage 2 levels.(ABSTRACT TRUNCATED AT 250 WORDS)

The importance of having a flexible scope ISO 15189 accreditation and quality specifications based on biological variation – the case of validation of the biochemistry analyzer Dimension Vista

PubMed Central

Fernandez-Calle, Pilar; Pelaz, Sandra; Oliver, Paloma; Alcaide, Maria Jose; Gomez-Rioja, Ruben; Buno, Antonio; Iturzaeta, Jose Manuel

2013-01-01

Introduction Technological innovation requires the laboratories to ensure that modifications or incorporations of new techniques do not alter the quality of their results. In an ISO 15189 accredited laboratory, flexible scope accreditation facilitates the inclusion of these changes prior to accreditation body evaluation. A strategy to perform the validation of a biochemistry analyzer in an accredited laboratory having a flexible scope is shown. Materials and methods: A validation procedure including the evaluation of imprecision and bias of two Dimension Vista analysers 1500 was conducted. Comparability of patient results between one of them and the lately replaced Dimension RxL Max was evaluated. All studies followed the respective Clinical and Laboratory Standards Institute (CLSI) protocols. 30 chemistry assays were studied. Coefficients of variation, percent bias and total error were calculated for all tests and biological variation was considered as acceptance criteria. Quality control material and patient samples were used as test materials. Interchangeability of the results was established by processing forty patients’ samples in both devices. Results: 27 of the 30 studied parameters met allowable performance criteria. Sodium, chloride and magnesium did not fulfil acceptance criteria. Evidence of interchangeability of patient results was obtained for all parameters except magnesium, NT-proBNP, cTroponin I and C-reactive protein. Conclusions: A laboratory having a well structured and documented validation procedure can opt to get a flexible scope of accreditation. In addition, performing these activities prior to use on patient samples may evidence technical issues which must be corrected to minimize their impact on patient results. PMID:23457769

The relationship of packed cell transfusion to red blood cell deformability in systemic inflammatory response syndrome patients.

PubMed

Friedlander, M H; Simon, R; Machiedo, G W

1998-02-01

RBC deformability (RBCD) is decreased in critically ill patients. This is thought to impede the passage of the RBC through the microcirculation. The cell transit analyzer (CTA) provides an evaluation of RBCD. RBCD was examined in 16 patients admitted to the surgical intensive care unit. CTA analysis was conducted within 24 h of admission to the surgical intensive care unit or as soon as possible thereafter, and then repeated every 72 h. Counts per second (C/s) was the parameter used as an index of RBCD. Patients were classified as Septic/SIRS or nonseptic at the time of each blood collection by standard clinical criteria. There were 34 total specimens, 22 septic/SIRS and 12 nonseptic. The C/s for the SIRS samples (41.7 +/- 3.4 was significantly (p < .05) lower than that of the non-SIRS samples (54.3 +/- 5.3). Seventeen of the Septic/SIRS samples were obtained following blood transfusion. Pearson's test calculated for the C/s and the total number of packed RBC transfusions showed a positive correlation (r = .594) that was statistically significant (p < .02). CTA was also performed on 10 U of banked packed RBC in vitro. Deformability was maintained at a constant level until the very end of the storage period, at which time there was a statistically significant decrease in C/s (p < .0001). These data suggest that packed RBC transfusion is associated with a significant improvement in the abnormally low RBCD seen in critically ill patients. This may be due to replacement of previously rigidified cells by cells with a more normal RBCD.

Lack of utility of arteriojugular venous differences of lactate as a reliable indicator of increased brain anaerobic metabolism in traumatic brain injury.

PubMed

Poca, Maria A; Sahuquillo, Juan; Vilalta, Anna; Garnacho, Angel

2007-04-01

Ischemic lesions are highly prevalent in patients with traumatic brain injuries (TBIs) and are the single most important cause of secondary brain damage. The prevention and early treatment of these lesions is the primary aim in the modem treatment of these patients. One of the most widely used monitoring techniques at the bedside is quantification of brain extracellular level of lactate by using arteriojugular venous differences of lactate (AVDL). The purpose of this study was to determine the sensitivity, specificity, and predictive value of AVDL as an indicator of increases in brain lactate production in patients with TBIs. Arteriojugular venous differences of lactate were calculated every 6 hours using samples obtained though a catheter placed in the jugular bulb in 45 patients with diffuse head injuries (57.8%) or evacuated brain lesions (42.2%). Cerebral lactate concentration obtained with a 20-kD microdialysis catheter implanted in undamaged tissue was used as the de facto gold standard. Six hundred seventy-three AVDL determinations and cerebral microdialysis samples were obtained simultaneously; 543 microdialysis samples (81%) showed lactate values greater than 2 mmol/L, but only 21 AVDL determinations (3.1%) showed an increase in brain lactate. No correlation was found between AVDL and cerebral lactate concentration (p = 0.014, p = 0.719). Arteriojugular venous differences of lactate had a sensitivity and specificity of 3.3 and 97.7%, respectively, with a false-negative rate of 96.7% and a false-positive rate of 2.3%. Arteriojugular venous differences of lactate do not reliably reflect increased cerebral lactate production and consequently are not reliable in ruling out brain ischemia in patients with TBIs. The clinical use of this monitoring method in neurocritical care should be reconsidered.

Reliability and Agreement Between Metrics of Cone Spacing in Adaptive Optics Images of the Human Retinal Photoreceptor Mosaic.

PubMed

Giannini, Daniela; Lombardo, Giuseppe; Mariotti, Letizia; Devaney, Nicholas; Serrao, Sebastiano; Lombardo, Marco

2017-06-01

To assess reliability and agreement among three metrics used to evaluate the distribution of cell distances in adaptive optics (AO) images of the cone mosaic. Using an AO flood illumination retinal camera, we acquired images of the cone mosaic in 20 healthy subjects and 12 patients with retinal diseases. The three spacing metrics studied were the center-to-center spacing (Scc), the local cone spacing (LCS), and the density recovery profile distance (DRPD). Each metric was calculated in sampling areas of different sizes (64 × 64 μm and 204 × 204 μm) across the parafovea. Both Scc and LCS were able to discriminate between healthy subjects and patients with retinal diseases; DRPD did not reliably detect any abnormality in the distribution of cell distances in patients with retinal diseases. The agreement between Scc and LCS was high in healthy subjects (intraclass correlation coefficient [ICC] ≥ 0.79) and moderate in patients with retinal diseases (ICC ≤ 0.51). The DRPD had poor agreement with Scc (ICC ≤ 0.47) and LCS (ICC ≤ 0.37). The correlation between the spacing metrics of the two sampling areas was greater in healthy subjects than in patients with retinal diseases. The Scc and LCS provided interchangeable estimates of cone distance in AO retinal images of healthy subjects but could not be used interchangeably when investigating retinal diseases with significant cell reflectivity loss (≥30%). The DRPD was unreliable for describing cell distance in a human retinal cone mosaic and did not correlate with Scc and LCS. Caution is needed when comparing spacing metrics evaluated in sampling areas of different sizes.

Description of a computer program to calculate reacting supersonic internal flow fields with shock waves using viscous characteristics: Program manual and sample calculations

NASA Technical Reports Server (NTRS)

Cavalleri, R. J.; Agnone, A. M.

1972-01-01

A computer program for calculating internal supersonic flow fields with chemical reactions and shock waves typical of supersonic combustion chambers with either wall or mid-stream injectors is described. The usefulness and limitations of the program are indicated. The program manual and listing are presented along with a sample calculation.

Numerical calculation of the Fresnel transform.

PubMed

Kelly, Damien P

2014-04-01

In this paper, we address the problem of calculating Fresnel diffraction integrals using a finite number of uniformly spaced samples. General and simple sampling rules of thumb are derived that allow the user to calculate the distribution for any propagation distance. It is shown how these rules can be extended to fast-Fourier-transform-based algorithms to increase calculation efficiency. A comparison with other theoretical approaches is made.

The level of serotonin in the superficial masseter muscle in relation to local pain and allodynia.

PubMed

Ernberg, M; Hedenberg-Magnusson, B; Alstergren, P; Kopp, S

1999-01-01

The aim of this study was to investigate if serotonin is present in the human masseter muscle and if so, whether it is involved in the modulation of local muscle pain or allodynia. Thirty-five patients with pain and tenderness of the masseter muscle as well as ten healthy individuals were included in the study. Of the patients, 18 suffered from fibromyalgia and 17 had localized myalgia, e.g. myofascial pain in the temporomandibular system. The participants were examined clinically with special consideration to the masseter muscle and the pressure pain threshold as well as tolerance levels of this muscle were assessed. Intramuscular microdialysis was performed in order to sample serotonin and a venous blood sample was collected for analysis of the serum level of serotonin. Serotonin was present in the masseter muscle and the level was significantly higher in the initial sample than in the sample collected during steady state. The level of serotonin in the masseter muscle in relation to the level of serotonin in the blood serum was calculated. This fraction of serotonin was higher in the patients with fibromyalgia than in healthy individuals and high level of serotonin was associated with pain as well as allodynia of the masseter muscle. In conclusion, the results of this study show that serotonin is present in the human masseter muscle both immediately following puncture and in a subsequent steady state and that it is associated with pain and allodynia. The origin of the serotonin seems partly to be the blood, but our results indicate that peripheral release also occurs.

Methodology to reduce 6D patient positional shifts into a 3D linear shift and its verification in frameless stereotactic radiotherapy

NASA Astrophysics Data System (ADS)

Sarkar, Biplab; Ray, Jyotirmoy; Ganesh, Tharmarnadar; Manikandan, Arjunan; Munshi, Anusheel; Rathinamuthu, Sasikumar; Kaur, Harpreet; Anbazhagan, Satheeshkumar; Giri, Upendra K.; Roy, Soumya; Jassal, Kanan; Kalyan Mohanti, Bidhu

2018-04-01

The aim of this article is to derive and verify a mathematical formulation for the reduction of the six-dimensional (6D) positional inaccuracies of patients (lateral, longitudinal, vertical, pitch, roll and yaw) to three-dimensional (3D) linear shifts. The formulation was mathematically and experimentally tested and verified for 169 stereotactic radiotherapy patients. The mathematical verification involves the comparison of any (one) of the calculated rotational coordinates with the corresponding value from the 6D shifts obtained by cone beam computed tomography (CBCT). The experimental verification involves three sets of measurements using an ArcCHECK phantom, when (i) the phantom was not moved (neutral position: 0MES), (ii) the position of the phantom shifted by 6D shifts obtained from CBCT (6DMES) from neutral position and (iii) the phantom shifted from its neutral position by 3D shifts reduced from 6D shifts (3DMES). Dose volume histogram and statistical comparisons were made between ≤ft< TPSCAL{\\text -}0MES \\right> and ≤ft< 3DMES{\\text -6DMES} \\right> . The mathematical verification was performed by a comparison of the calculated and measured yaw (γ°) rotation values, which gave a straight line, Y  =  1X with a goodness of fit as R 2  =  0.9982. The verification, based on measurements, gave a planning target volume receiving 100% of the dose (V100%) as 99.1  ±  1.9%, 96.3  ±  1.8%, 74.3  ±  1.9% and 72.6  ±  2.8% for the calculated treatment planning system values TPSCAL, 0MES, 3DMES and 6DMES, respectively. The statistical significance (p-values: paired sample t-test) of V100% were found to be 0.03 for the paired sample ≤ft< 3DMES{\\text -6DMES} \\right> and 0.01 for ≤ft< 0MES{\\text -TPSCAL} \\right> . In this paper, a mathematical method to reduce 6D shifts to 3D shifts is presented. The mathematical method is verified by using well-matched values between the measured and calculated γ°. Measurements done on the ArcCHECK phantom also proved that the proposed methodology is correct. The post-correction of the table position condition introduces a minimal spatial dose delivery error in the frameless stereotactic system, using a 6D motion enabled robotic couch. This formulation enables the reduction of 6D positional inaccuracies to 3D linear shifts, and hence allows the treatment of patients with frameless stereotactic radiosurgery by using only a 3D linear motion enabled couch.

Methodology to reduce 6D patient positional shifts into a 3D linear shift and its verification in frameless stereotactic radiotherapy.

PubMed

Sarkar, Biplab; Ray, Jyotirmoy; Ganesh, Tharmarnadar; Manikandan, Arjunan; Munshi, Anusheel; Rathinamuthu, Sasikumar; Kaur, Harpreet; Anbazhagan, Satheeshkumar; Giri, Upendra K; Roy, Soumya; Jassal, Kanan; Mohanti, Bidhu Kalyan

2018-03-22

The aim of this article is to derive and verify a mathematical formulation for the reduction of the six-dimensional (6D) positional inaccuracies of patients (lateral, longitudinal, vertical, pitch, roll and yaw) to three-dimensional (3D) linear shifts. The formulation was mathematically and experimentally tested and verified for 169 stereotactic radiotherapy patients. The mathematical verification involves the comparison of any (one) of the calculated rotational coordinates with the corresponding value from the 6D shifts obtained by cone beam computed tomography (CBCT). The experimental verification involves three sets of measurements using an ArcCHECK phantom, when (i) the phantom was not moved (neutral position: 0MES), (ii) the position of the phantom shifted by 6D shifts obtained from CBCT (6DMES) from neutral position and (iii) the phantom shifted from its neutral position by 3D shifts reduced from 6D shifts (3DMES). Dose volume histogram and statistical comparisons were made between [Formula: see text] and [Formula: see text]. The mathematical verification was performed by a comparison of the calculated and measured yaw (γ°) rotation values, which gave a straight line, Y  =  1X with a goodness of fit as R 2   =  0.9982. The verification, based on measurements, gave a planning target volume receiving 100% of the dose (V100%) as 99.1  ±  1.9%, 96.3  ±  1.8%, 74.3  ±  1.9% and 72.6  ±  2.8% for the calculated treatment planning system values TPSCAL, 0MES, 3DMES and 6DMES, respectively. The statistical significance (p-values: paired sample t-test) of V100% were found to be 0.03 for the paired sample [Formula: see text] and 0.01 for [Formula: see text]. In this paper, a mathematical method to reduce 6D shifts to 3D shifts is presented. The mathematical method is verified by using well-matched values between the measured and calculated γ°. Measurements done on the ArcCHECK phantom also proved that the proposed methodology is correct. The post-correction of the table position condition introduces a minimal spatial dose delivery error in the frameless stereotactic system, using a 6D motion enabled robotic couch. This formulation enables the reduction of 6D positional inaccuracies to 3D linear shifts, and hence allows the treatment of patients with frameless stereotactic radiosurgery by using only a 3D linear motion enabled couch.

Estimation of the diagnostic threshold accounting for decision costs and sampling uncertainty.

PubMed

Skaltsa, Konstantina; Jover, Lluís; Carrasco, Josep Lluís

2010-10-01

Medical diagnostic tests are used to classify subjects as non-diseased or diseased. The classification rule usually consists of classifying subjects using the values of a continuous marker that is dichotomised by means of a threshold. Here, the optimum threshold estimate is found by minimising a cost function that accounts for both decision costs and sampling uncertainty. The cost function is optimised either analytically in a normal distribution setting or empirically in a free-distribution setting when the underlying probability distributions of diseased and non-diseased subjects are unknown. Inference of the threshold estimates is based on approximate analytically standard errors and bootstrap-based approaches. The performance of the proposed methodology is assessed by means of a simulation study, and the sample size required for a given confidence interval precision and sample size ratio is also calculated. Finally, a case example based on previously published data concerning the diagnosis of Alzheimer's patients is provided in order to illustrate the procedure.

Calculating the dim light melatonin onset: the impact of threshold and sampling rate.

PubMed

Molina, Thomas A; Burgess, Helen J

2011-10-01

The dim light melatonin onset (DLMO) is the most reliable circadian phase marker in humans, but the cost of assaying samples is relatively high. Therefore, the authors examined differences between DLMOs calculated from hourly versus half-hourly sampling and differences between DLMOs calculated with two recommended thresholds (a fixed threshold of 3 pg/mL and a variable "3k" threshold equal to the mean plus two standard deviations of the first three low daytime points). The authors calculated these DLMOs from salivary dim light melatonin profiles collected from 122 individuals (64 women) at baseline. DLMOs derived from hourly sampling occurred on average only 6-8 min earlier than the DLMOs derived from half-hourly saliva sampling, and they were highly correlated with each other (r ≥ 0.89, p < .001). However, in up to 19% of cases the DLMO derived from hourly sampling was >30 min from the DLMO derived from half-hourly sampling. The 3 pg/mL threshold produced significantly less variable DLMOs than the 3k threshold. However, the 3k threshold was significantly lower than the 3 pg/mL threshold (p < .001). The DLMOs calculated with the 3k method were significantly earlier (by 22-24 min) than the DLMOs calculated with the 3 pg/mL threshold, regardless of sampling rate. These results suggest that in large research studies and clinical settings, the more affordable and practical option of hourly sampling is adequate for a reasonable estimate of circadian phase. Although the 3 pg/mL fixed threshold is less variable than the 3k threshold, it produces estimates of the DLMO that are further from the initial rise of melatonin.

Infective endocarditis detection through SPECT/CT images digital processing

NASA Astrophysics Data System (ADS)

Moreno, Albino; Valdés, Raquel; Jiménez, Luis; Vallejo, Enrique; Hernández, Salvador; Soto, Gabriel

2014-03-01

Infective endocarditis (IE) is a difficult-to-diagnose pathology, since its manifestation in patients is highly variable. In this work, it was proposed a semiautomatic algorithm based on SPECT images digital processing for the detection of IE using a CT images volume as a spatial reference. The heart/lung rate was calculated using the SPECT images information. There were no statistically significant differences between the heart/lung rates values of a group of patients diagnosed with IE (2.62+/-0.47) and a group of healthy or control subjects (2.84+/-0.68). However, it is necessary to increase the study sample of both the individuals diagnosed with IE and the control group subjects, as well as to improve the images quality.

Time-dependent importance sampling in semiclassical initial value representation calculations for time correlation functions.

PubMed

Tao, Guohua; Miller, William H

2011-07-14

An efficient time-dependent importance sampling method is developed for the Monte Carlo calculation of time correlation functions via the initial value representation (IVR) of semiclassical (SC) theory. A prefactor-free time-dependent sampling function weights the importance of a trajectory based on the magnitude of its contribution to the time correlation function, and global trial moves are used to facilitate the efficient sampling the phase space of initial conditions. The method can be generally applied to sampling rare events efficiently while avoiding being trapped in a local region of the phase space. Results presented in the paper for two system-bath models demonstrate the efficiency of this new importance sampling method for full SC-IVR calculations.

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

PubMed

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

2017-01-01

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

Nodal Clearance Rate and Long-Term Efficacy of Individualized Sentinel Node–Based Pelvic Intensity Modulated Radiation Therapy for High-Risk Prostate Cancer

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

Müller, Arndt-Christian, E-mail: arndt-christian.mueller@med.uni-tuebingen.de; Eckert, Franziska; Paulsen, Frank

2016-02-01

Purpose: To assess the efficacy of individual sentinel node (SN)-guided pelvic intensity modulated radiation therapy (IMRT) by determining nodal clearance rate [(n expected nodal involvement − n observed regional recurrences)/n expected nodal involvement] in comparison with surgically staged patients. Methods and Materials: Data on 475 high-risk prostate cancer patients were examined. Sixty-one consecutive patients received pelvic SN-based IMRT (5 × 1.8 Gy/wk to 50.4 Gy [pelvic nodes + individual SN] and an integrated boost with 5 × 2.0 Gy/wk to 70.0 Gy to prostate + [base of] seminal vesicles) and neo-/adjuvant long-term androgen deprivation therapy; 414 patients after SN–pelvic lymph node dissection were used to calculate the expected nodal involvement rate for the radiation therapymore » sample. Biochemical control and overall survival were estimated for the SN-IMRT patients using the Kaplan-Meier method. The expected frequency of nodal involvement in the radiation therapy group was estimated by imputing frequencies of node-positive patients in the surgical sample to the pattern of Gleason, prostate-specific antigen, and T category in the radiation therapy sample. Results: After a median follow-up of 61 months, 5-year OS after SN-guided IMRT reached 84.4%. Biochemical control according to the Phoenix definition was 73.8%. The nodal clearance rate of SN-IMRT reached 94%. Retrospective follow-up evaluation is the main limitation. Conclusions: Radiation treatment of pelvic nodes individualized by inclusion of SNs is an effective regional treatment modality in high-risk prostate cancer patients. The pattern of relapse indicates that the SN-based target volume concept correctly covers individual pelvic nodes. Thus, this SN-based approach justifies further evaluation, including current dose-escalation strategies to the prostate in a larger prospective series.« less

The relationship between patient safety climate and occupational safety climate in healthcare - A multi-level investigation.

PubMed

Pousette, Anders; Larsman, Pernilla; Eklöf, Mats; Törner, Marianne

2017-06-01

Patient safety climate/culture is attracting increasing research interest, but there is little research on its relation with organizational climates regarding other target domains. The aim of this study was to investigate the relationship between patient safety climate and occupational safety climate in healthcare. The climates were assessed using two questionnaires: Hospital Survey on Patient Safety Culture and Nordic Occupational Safety Climate Questionnaire. The final sample consisted of 1154 nurses, 886 assistant nurses, and 324 physicians, organized in 150 work units, within hospitals (117units), primary healthcare (5units) and elderly care (28units) in western Sweden, which represented 56% of the original sample contacted. Within each type of safety climate, two global dimensions were confirmed in a higher order factor analysis; one with an external focus relative the own unit, and one with an internal focus. Two methods were used to estimate the covariation between the global climate dimensions, in order to minimize the influence of bias from common method variance. First multilevel analysis was used for partitioning variances and covariances in a within unit part (individual level) and a between unit part (unit level). Second, a split sample technique was used to calculate unit level correlations based on aggregated observations from different respondents. Both methods showed associations similar in strength between the patient safety climate and the occupational safety climate domains. The results indicated that patient safety climate and occupational safety climate are strongly positively related at the unit level, and that the same organizational processes may be important for the development of both types of organizational climate. Safety improvement interventions should not be separated in different organizational processes, but be planned so that both patient safety and staff safety are considered concomitantly. Copyright © 2017 National Safety Council and Elsevier Ltd. All rights reserved.

Expression of CD56 in patients with adenomyosis and its correlation with dysmenorrhea.

PubMed

Wang, Fei; Shi, Xixi; Qin, Xiaoyan; Wen, ZeQing; Zhao, Xingbo; Li, Changzhong

2015-11-01

To investigate the expression of CD56 in endometrial samples from patients with adenomyosis and its relationship with menstrual cycle phase and severity of dysmenorrhea. 40 patients with histologically proved adenomyosis (proliferative n=20; secretory n=20) and dysmenorrhea were examined in this study, control groups includes 20 patients with adenomyosis without dysmenorrhea (main complaint: menorrhagia) and 20 patients without adenomyosis who had undergone hysterectomy for non-endometrial pathology (no dysmenorrhea medical history). Immunohistochemical staining against CD56 was performed for the eutopic and ectopic endometrium from patients with adenomyosis and the control samples. The expression of CD56 was determined by calculating the H-score and the severity of dysmenorrhea was determined using the visual analogue scale. The menstrual cycle status and the disease severity were compared to the levels of staining. CD56 was expressed mainly in the endometrial glandular epithelium in patients with adenomyosis and normal endometrium. The epithelial staining intensity of CD56 in ectopic lesions of adenomyosis with dysmenorrhea was obviously higher than in the corresponding eutopic endometrium and control groups (P<0.01). There were no statistical differences in the expression between normal endometrium, eutopic endometrium of adenomyosis with dysmenorrhea and adenomyostic samples without dysmenorrhea. For eutopic endometrium in adenomyosis with dysmenorrhea, expression was higher in the secretory phases than in the proliferative phase (P<0.05). The increased CD56 immunoreactivity correlated with the severity of dysmenorrhea (spearman rho=0.84, P<0.01). These findings suggest that the expression of CD56 in adenomyosis is positively associated with the severity of dysmenorrhea. Endometrial glandular epithelium is likely to secrete more CD56 and stimulating nerve growth in the stroma, which could then play a role in the pathogenesis of adenomoysis-related dysmenorrhea. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Does Core Length Taken per cc of Prostate Volume in Prostate Biopsy Affect the Diagnosis of Prostate Cancer?

PubMed

Deliktas, Hasan; Sahin, Hayrettin; Cetinkaya, Mehmet; Dere, Yelda; Erdogan, Omer; Baldemir, Ercan

2016-08-01

The aim of this study was to determine the minimal core length to be taken per cc of prostate volume for an effective prostate biopsy. A retrospective analysis was performed on the records of 379 patients who underwent a first prostate biopsy with 12 to 16 cores under transrectal ultrasound guidance between September 2012 and April 2015. For each patient, the core length per cc of the prostate and the percentage of sampled prostate volume were calculated, and these values were compared between the patients with and without prostate cancer. A total of 348 patients were included in the study. Cancer was determined in 26.4% of patients. The mean core length taken per cc of prostate and the percentage of sampled prostate volume were determined to be 3.40 ± 0.15 mm/cc (0.26%; range, 0.08-0.63 cc) in patients with cancer and 2.75 ± 0.08 mm/cc (0.20%; range, 0.04-0.66 cc) in patients without cancer (P = .000 and P = .000), respectively. Core length taken per cc of prostate of > 3.31 mm/cc was found to be related to an increase in the rates of prostate cancer diagnosis (odds ratio, 2.84; 95% confidence interval, 1.68-4.78). The rate of cancer determination for core length taken per cc of prostate of < 3.31 mm/cc was 19.9% and of > 3.31 mm/cc, 41.1%. Core length taken per cc of prostate and the percentage of sampled prostate volume are important morphometric parameters in the determination of prostate cancer. The results of study suggest a core length per cc of the prostate of > 3.31 mm/cc as a cutoff value for quality assurance. Copyright © 2016 Elsevier Inc. All rights reserved.

Carbon storage and sequestration by trees in VIT University campus

NASA Astrophysics Data System (ADS)

Saral, A. Mary; SteffySelcia, S.; Devi, Keerthana

2017-11-01

The present study addresses carbon storage and sequestration by trees grown in VIT University campus, Vellore. Approximately twenty trees were selected from Woodstockarea. The above ground biomass and below ground biomass were calculated. The above ground biomass includes non-destructive anddestructive sampling. The Non-destructive method includes the measurement of height of thetree and diameter of the tree. The height of the tree is calculated using Total Station instrument and diameter is calculated using measuring tape. In the destructive method the weight of samples (leaves) and sub-samples (fruits, flowers) of the tree were considered. To calculate the belowground biomass soil samples are taken and analyzed. The results obtained were used to predict the carbon storage. It was found that out of twenty tree samples Millingtonia hortensis which is commonly known as Cork tree possess maximum carbon storage (14.342kg/tree) and carbon sequestration (52.583kg/tree) respectively.

Polyethylene glycol intestinal lavage in addition to usual antibiotic treatment for severe Clostridium difficile colitis: a randomised controlled pilot study.

PubMed

McCreery, Greig; Jones, Philip M; Kidane, Biniam; DeMelo, Vanessa; Mele, Tina

2017-07-31

Clostridium difficile infections (CDI) are common, costly and potentially life threatening. Most CDI will respond to antibiotic therapy, but 3%-10% of all patients with CDI will progress to a severe, life-threatening course. Complete removal of the large bowel is indicated for severe CDI. However, the 30-day mortality following surgical intervention for severe CDI ranges from 20% to 70%. A less invasive approach using surgical faecal diversion and direct colonic lavage with polyethylene glycol (PEG) and vancomycin has demonstrated a relative mortality reduction of approximately 50%. As an alternative to these operative approaches, we propose to treat patients with bedside intestinal lavage with PEG and vancomycin instillation via nasojejunal tube, in addition to usual antibiotic management. Preliminary data collected by our research group are encouraging. We will conduct a 1-year, single-centre, pilot randomised controlled trial to study this new treatment strategy for patients with severe CDI and additional risk factors for fulminant or complicated infection. After informed consent, patients with severe-complicated CDI without immediate indication for surgery will be randomised to either usual antibiotic treatment or usual antibiotic treatment with the addition of 8 L of PEG lavage via nasojejunal tube. This pilot trial will evaluate our eligibility and enrolment rate, protocol compliance and adverse event rates and provide further data to inform a more robust sample size calculation and protocol modifications for a definitive multicentre trial design. Based on historical data, we anticipate enrolling approximately 24 patients during the 1-year pilot study period.As a pilot study, data will be reported in aggregate. Between-group differences will be assessed in a blinded fashion for evidence of harm, and to further refine our sample size calculation. This study protocol has been reviewed and approved by our local institutional review board. Results of the pilot trial and subsequent main trial will be submitted for publication in a peer-reviewed journal. NCT02466698; Pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Variability of sweat chloride concentration in subjects with cystic fibrosis and G551D mutations.

PubMed

Vermeulen, F; Le Camus, C; Davies, J C; Bilton, D; Milenković, D; De Boeck, K

2017-01-01

Sweat chloride concentration, a biomarker of CFTR function, is an appropriate outcome parameter in clinical trials aimed at correcting the basic CF defect. Although there is consensus on a cut-off value to diagnose CF, we have only limited information on the within subject variability of sweat chloride over time. Such information would be useful for sample size calculations in clinical trials. Therefore, we retrospectively analyzed repeated sweat chloride values obtained in patients with G551D mutation(s) assigned to placebo in an ivacaftor interventional trial. In subjects with G551D at least 12years of age, a pilocarpine sweat test using Macroduct collector was taken on both arms at 8 time points over 48weeks. We explored 1062 pilocarpine sweat test values obtained in 78 placebo patients of the VX08-770-102 trial. Mean overall sweat chloride value (all patients, all tests, n=1062) was 100.8mmol/L (SD 12.7mmol/L). Using a multilevel mixed model, the between-subject standard deviation (SD) for sweat chloride was 8.9mmol/L (95% CI 7.4-10.6) and within-subject SD was 8.1mmol/L (95% CI 7.5-8.7). Limits of repeatability for repeat measurements were -19.7 to +21.6mmol/L using values from one arm, and -13.3 to 11.8mmol/L using mean of values obtained at 4 test occasions. Sample size calculations showed that the minimal treatment effect on sweat chloride concentration that can be demonstrated for a group of 5 patients is around 15mmol/L, using a cross-over design and combinations of 4 tests for each phase of the trial. Although the sweat test is considered a robust measure, sweat chloride measurements in patients with CF and a G551D mutation had an inherent biological variability that is higher than commonly considered. Further analyses of placebo group data are crucial to learn more about the natural variability of this outcome parameter. Copyright © 2016 European Cystic Fibrosis Society. Published by Elsevier B.V. All rights reserved.

Polyethylene glycol intestinal lavage in addition to usual antibiotic treatment for severe Clostridium difficile colitis: a randomised controlled pilot study

PubMed Central

McCreery, Greig; Jones, Philip M; Kidane, Biniam; DeMelo, Vanessa

2017-01-01

Introduction Clostridium difficile infections (CDI) are common, costly and potentially life threatening. Most CDI will respond to antibiotic therapy, but 3%–10% of all patients with CDI will progress to a severe, life-threatening course. Complete removal of the large bowel is indicated for severe CDI. However, the 30-day mortality following surgical intervention for severe CDI ranges from 20% to 70%. A less invasive approach using surgical faecal diversion and direct colonic lavage with polyethylene glycol (PEG) and vancomycin has demonstrated a relative mortality reduction of approximately 50%. As an alternative to these operative approaches, we propose to treat patients with bedside intestinal lavage with PEG and vancomycin instillation via nasojejunal tube, in addition to usual antibiotic management. Preliminary data collected by our research group are encouraging. Methods and analysis We will conduct a 1-year, single-centre, pilot randomised controlled trial to study this new treatment strategy for patients with severe CDI and additional risk factors for fulminant or complicated infection. After informed consent, patients with severe-complicated CDI without immediate indication for surgery will be randomised to either usual antibiotic treatment or usual antibiotic treatment with the addition of 8 L of PEG lavage via nasojejunal tube. This pilot trial will evaluate our eligibility and enrolment rate, protocol compliance and adverse event rates and provide further data to inform a more robust sample size calculation and protocol modifications for a definitive multicentre trial design. Based on historical data, we anticipate enrolling approximately 24 patients during the 1-year pilot study period. As a pilot study, data will be reported in aggregate. Between-group differences will be assessed in a blinded fashion for evidence of harm, and to further refine our sample size calculation. Ethics and dissemination This study protocol has been reviewed and approved by our local institutional review board. Results of the pilot trial and subsequent main trial will be submitted for publication in a peer-reviewed journal. Trial registration number NCT02466698; Pre-results. PMID:28760801

Effectiveness of a Clinical Skills Workshop for drug-dosage calculation in a nursing program.

PubMed

Grugnetti, Anna Maria; Bagnasco, Annamaria; Rosa, Francesca; Sasso, Loredana

2014-04-01

Mathematical and calculation skills are widely acknowledged as being key nursing competences if patients are to receive care that is both effective and safe. Indeed, weaknesses in mathematical competence may lead to the administration of miscalculated drug doses, which in turn may harm or endanger patients' lives. However, little attention has been given to identifying appropriate teaching and learning strategies that will effectively facilitate the development of these skills in nurses. One such approach may be simulation. To evaluate the effectiveness of a Clinical Skills Workshop on drug administration that focused on improving the drug-dosage calculation skills of second-year nursing students, with a view to promoting safety in drugs administration. A descriptive pre-post test design. Educational. Simulation center. The sample population included 77 nursing students from a Northern Italian University who attended a 30-hour Clinical Skills Workshop over a period of two weeks. The workshop covered integrated teaching strategies and innovative drug-calculation methodologies which have been described to improve psychomotor skills and build cognitive abilities through a greater understanding of mathematics linked to clinical practice. Study results showed a significant improvement between the pre- and the post-test phases, after the intervention. Pre-test scores ranged between 0 and 25 out of a maximum of 30 points, with a mean score of 15.96 (SD 4.85), and a median score of 17. Post-test scores ranged between 15 and 30 out of 30, with a mean score of 25.2 (SD 3.63) and a median score of 26 (p<0.001). Our study shows that Clinical Skills Workshops may be tailored to include teaching techniques that encourage the development of drug-dosage calculation skills, and that training strategies implemented during a Clinical skills Workshop can enhance students' comprehension of mathematical calculations. Copyright © 2013 Elsevier Ltd. All rights reserved.

SU-F-T-192: Study of Robustness Analysis Method of Multiple Field Optimized IMPT Plans for Head & Neck Patients

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

Li, Y; Wang, X; Li, H

Purpose: Proton therapy is more sensitive to uncertainties than photon treatments due to protons’ finite range depending on the tissue density. Worst case scenario (WCS) method originally proposed by Lomax has been adopted in our institute for robustness analysis of IMPT plans. This work demonstrates that WCS method is sufficient enough to take into account of the uncertainties which could be encountered during daily clinical treatment. Methods: A fast and approximate dose calculation method is developed to calculate the dose for the IMPT plan under different setup and range uncertainties. Effects of two factors, inversed square factor and range uncertainty,more » are explored. WCS robustness analysis method was evaluated using this fast dose calculation method. The worst-case dose distribution was generated by shifting isocenter by 3 mm along x,y and z directions and modifying stopping power ratios by ±3.5%. 1000 randomly perturbed cases in proton range and x, yz directions were created and the corresponding dose distributions were calculated using this approximated method. DVH and dosimetric indexes of all 1000 perturbed cases were calculated and compared with the result using worst case scenario method. Results: The distributions of dosimetric indexes of 1000 perturbed cases were generated and compared with the results using worst case scenario. For D95 of CTVs, at least 97% of 1000 perturbed cases show higher values than the one of worst case scenario. For D5 of CTVs, at least 98% of perturbed cases have lower values than worst case scenario. Conclusion: By extensively calculating the dose distributions under random uncertainties, WCS method was verified to be reliable in evaluating the robustness level of MFO IMPT plans of H&N patients. The extensively sampling approach using fast approximated method could be used in evaluating the effects of different factors on the robustness level of IMPT plans in the future.« less

Perioperative dynamics and significance of plasma-free amino acid profiles in colorectal cancer.

PubMed

Katayama, Kayoko; Higuchi, Akio; Yamamoto, Hiroshi; Ikeda, Atsuko; Kikuchi, Shinya; Shiozawa, Manabu

2018-02-21

For early detection of cancer, we have previously developed the AminoIndex Cancer Screening (AICS) system, which quantifies 6 plasma-free amino acids (PFAAs) in blood samples. Herein, we examined the usefulness of the AICS in patients with colorectal cancer (CRC) by comparing the preoperative and postoperative PFAA profiles. Our study cohort consisted of 62 patients who had undergone curative resection for CRC at our cancer center, with no recurrence at the time of the study. Blood samples were collected from fasted patients within 1 week before the resection and at 0.5-6.5 years post-resection. Following plasmapheresis, the PFAA levels were measured via liquid chromatography/mass spectrometry, and the AICS values were computed (the higher the value, the greater the probability of cancer). Risk was calculated from the AICS value and ranked as A, B, or C, with rank C representing the highest risk. All patients in our study were rank B + C. The postoperative AICS value was lower than the preoperative value in 57 of the 62 patients; the rank was also lower postoperatively (49 patients, p < 0.001). The decline in both was stage-independent, even occurring in patients with right-sided tumors or poorly differentiated adenocarcinomas. For comparative purposes, the levels of 2 tumor markers (carbohydrate antigen 19-9 and carcinoembryonic antigen) were also examined; these were within the reference ranges in 70-80% of patients preoperatively and in 80-90% postoperatively. We suggest that tumor-bearing conditions alter the PFAA profiles, which may be used to predict prognosis and monitor for recurrence in CRC patients after tumor resection. This trial has been retrospectively registered at UMIN-CTR R000028005 , Oct 06, 2016.

The effect of bronchodilators on forced vital capacity measurement in patients with idiopathic pulmonary fibrosis

PubMed Central

Assayag, Deborah; Vittinghoff, Eric; Ryerson, Christopher J.; Cocconcelli, Elisabetta; Tonelli, Roberto; Hu, Xiaowen; Elicker, Brett M.; Golden, Jeffrey A.; Jones, Kirk D.; King, Talmadge E.; Koth, Laura L.; Lee, Joyce S.; Ley, Brett; Shum, Anthony K.; Wolters, Paul J.; Ryu, Jay H.; Collard, Harold R.

2015-01-01

Background Forced vital capacity (FVC) is a key measure of disease severity in patients with idiopathic pulmonary fibrosis (IPF) and is an important clinical trial endpoint. We hypothesize that reversible airflow limitation co-exists in a subgroup of patients with IPF, and that bronchodilator use will improve the performance characteristics of FVC. Methods IPF patients with pre and post-bronchodilator spirometry testing performed were identified from two tertiary referral cohorts. The difference between pre and post-bronchodilator FVC (intra-test difference) was calculated. The test characteristics of pre and post-bronchodilator FVC change over time (inter-test difference) were assessed in patients with sequential spirometry, and were used to generate sample size estimates for hypothetical clinical trials using change in FVC as the primary endpoint. Results There were 551 patients, contributing 967 unique spirometry tests. The mean intra-test increase in FVC with bronchodilator use was 0.04 liters (2.71 vs. 2.75 liters, p <0.001). Reversible airflow limitation (increase in FEV1 or FVC of ≥12% and ≥200 milliliters) occurred in 9.1% of patients. The inter-test difference in change in FVC over time were equivalent for pre and post-bronchodilator (p = 0.65), leading to similar sample size estimates in a hypothetical clinical trial using change in FVC as the primary endpoint. Conclusion Approximately one in ten patients with IPF has physiological evidence of reversible airflow limitation, and bronchodilator use in these patients may improve the assessment of disease progression based on FVC change over time. Bronchodilator use does not appear to meaningfully impact the precision of FVC as an endpoint in clinical trials. PMID:26140806

The Prostate Health Index in predicting initial prostate biopsy outcomes in Asian men with prostate-specific antigen levels of 4-10 ng/mL.

PubMed

Ng, C F; Chiu, Peter K F; Lam, N Y; Lam, H C; Lee, Kim W M; Hou, Simon S M

2014-04-01

To investigate the role of the Prostate Health Index (phi) in prostate cancer (PCa) detection in patients with a prostate-specific antigen (PSA) level of 4-10 ng/mL receiving their first prostatic biopsy in an Asian population. This was a retrospective study of archived serum samples from patients enlisted in our tissue bank. Patients over 50 years old, with PSA level of 4-10 ng/mL, a negative digital rectal examination, and received their first prostatic biopsy between April 2008 and April 2013, were recruited. The serum sample collected before biopsy was retrieved for the measurement of various PSA derivatives and the phi value was calculated for each patient. The performance of these parameters in predicting the prostatic biopsy results was assessed. Two hundred and thirty consecutive patients, with 21 (9.13 %) diagnosed with PCa, were recruited for this study. Statistically significant differences between PCa patients and non-PCa patients were found for total PSA, PSA density, [-2]proPSA (p2PSA), free-to-total PSA ratio (%fPSA), p2PSA-to-free PSA ratio (%p2PSA), and phi. The areas under the curve of the receiver operating characteristic curve for total PSA, PSA density, %fPSA, %p2PSA, and phi were 0.547, 0.634, 0.654, 0.768, and 0.781, respectively. The phi was the best predictor of the prostatic biopsies results. At a sensitivity of 90 %, the use of the phi could have avoided unnecessary biopsies in 104 (45.2 %) patients. Use of the phi could improve the accuracy of PCa detection in patients with an elevated PSA level and thus avoid unnecessary prostatic biopsies.

More complications with uncemented than cemented femoral stems in total hip replacement for displaced femoral neck fractures in the elderly

PubMed Central

Chammout, Ghazi; Muren, Olle; Laurencikas, Evaldas; Bodén, Henrik; Kelly-Pettersson, Paula; Sjöö, Helene; Stark, André; Sköldenberg, Olof

2017-01-01

Background and purpose Total hip replacement (THR) is the preferred method for the active and lucid elderly patient with a displaced femoral neck fracture (FNF). Controversy still exists regarding the use of cemented or uncemented stems in these patients. We compared the effectiveness and safety between a modern cemented, and a modern uncemented hydroxyapatite-coated femoral stem in patients 65–79 years of age who were treated with THR for displaced FNF. Patients and methods In a single-center, single-blinded randomized controlled trial, we included 69 patients, mean age 75 (65–79) and with a displaced FNF (Garden III–IV). 35 patients were randomized to a cemented THR and 34 to a reverse-hybrid THR with an uncemented stem. Primary endpoints were: prevalence of all hip-related complications and health-related quality of life, evaluated with EuroQol-5D (EQ-5D) index up to 2 years after surgery. Secondary outcomes included: overall mortality, general medical complications, and hip function. The patients were followed up at 3, 12, and 24 months. Results According to the calculation of sample size, 140 patients would be required for the primary endpoints, but the study was stopped when only half of the sample size was included (n = 69). An interim analysis at that time showed that the total number of early hip-related complications was substantially higher in the uncemented group, 9 (among them, 3 dislocations and 4 periprosthetic fractures) as compared to 1 in the cemented group. The mortality and functional outcome scores were similar in the 2 groups. Interpretation We do not recommend uncemented femoral stems for the treatment of elderly patients with displaced FNFs. PMID:27967333

Evaluation of dynamic thiol/disulphide homeostasis as a novel indicator of oxidative stress in maple syrup urine disease patients under treatment.

PubMed

Zubarioglu, Tanyel; Kiykim, Ertugrul; Cansever, Mehmet Serif; Neselioglu, Salim; Aktuglu-Zeybek, Cigdem; Erel, Ozcan

2017-02-01

Maple syrup urine disease (MSUD) is a metabolic disorder that is caused by deficiency of branched-chain α-keto acid dehydrogenase complex. Although accumulation of toxic metabolites is associated with neurotoxicity, mechanisms underlying brain damage remain unclear. Aim of this study is to evaluate thiol/disulphide homeostasis as a novel indicator of oxidative stress in MSUD patients under treatment. Twenty patients with MSUD and 20 healthy individuals were included in study. All patients were under regular follow-up and had a good metabolic control. Serum native thiol (-SH), total thiol (-SH + -S-S-), disulphide (-S-S) levels were measured in all subjects. Disulphide/native thiol, disulphide/total thiol and native thiol/total thiol ratios were calculated from these values. Simultaneous blood sampling for plasma quantitative amino acid analysis was performed in both groups. Any significant difference was not observed in -SH, -SH + -S-S-, -S-S levels between two groups. In addition no increase of disulphide/native thiol and disulphide/total thiol ratios was detected in patient group. This study is the first study that evaluates dynamic thiol/disulphide homeostasis as an indicator of oxidative stress in MSUD patients. Among previous studies that were made to determine oxidative stress in treated MSUD patients, this study had the largest sample size also. In recent studies, it was claimed that oxidative stress could be responsible from neurotoxicity even in treated patients. Here, dynamic thiol/disulfide homeostasis status showed that providing good metabolic control in MSUD patients prevent oxidative stress. Under regular follow-up and good compliance with diet, additional antioxidant therapies would possibly not be necessary.

[Correlations between OCT4 expression and clinicopathological factors and prognosis of patients with lung adenocarcinoma].

PubMed

Zhang, Xueyan; Wang, Huimin; Jin, Bo; Dong, Qianggang; Huang, Jinsu; Han, Baohui

2013-04-01

In recent years, cases of lung adenocarcinoma morbidity have consistently grown. OCT4 is the key gene that controls the automatic renewal of stem cells, and regulates the proliferation and differentiation of cancer stem cells. The aim of this study is to detect OCT4 expression in lung adenocarcinoma tissues, and to evaluate its relevance in the metastasis, chemotherapeutic effect, and prognosis in lung adenocarcinoma patients. Immunofluorescence method was employed to detect OCT4 expression in lung adenocarcinoma tissues. The relationship between OCT4 expression and clinical pathological indicators is examined through chi-square test. Moreover, the survival rate is calculated through the Kaplan-Meier survivorship curve. Finally, the relevance between the indicators and patient survival is estimated using Cox analysis. Among the 126 tissue samples of lung adenocarcinoma, 91 showed OCT4 positive cells. OCT4 expression is closely related to metastasis and chemoresistance in lung adenocarcinoma patients, and negatively corresponds to the patients' disease-free survival and survival periods. OCT4 expression is related to metastasis and chemoresistance in lung adenocarcinoma patients, and thus indicates poor prognosis.

Are oxidative stress markers useful to distinguish schizoaffective disorder from schizophrenia and bipolar disorder?

PubMed

Bulbul, Feridun; Virit, Osman; Alpak, Gokay; Unal, Ahmet; Bulut, Mahmut; Kaya, Mehmet Cemal; Altindag, Abdurrahman; Celik, Hakim; Savas, Haluk A

2014-04-01

Schizoaffective disorder is a disease with both affective and psychotic symptoms. In this study, we aimed to compare oxidative metabolism markers of schizoaffective disorder, bipolar disorder and schizophrenic patients. Furthermore, we also aimed to investigate whether schizoaffective disorder could be differentiated from schizophrenia and bipolar disorder in terms of oxidative metabolism. Total oxidant status (TOS) and total antioxidant status (TAS) were measured in the blood samples that were collected from schizoaffective patients (n = 30), bipolar disorder patients (n = 30) and schizophrenic patients (n = 30). Oxidative stress index (OSI) was calculated by dividing TOS by TAS. TOS and OSI were found to be higher in patients with schizoaffective disorder compared with those in schizophrenia and bipolar disorder patients. TAS was not significantly different between the groups. Schizoaffective disorder was found to be different from bipolar disorder and schizophrenia in terms of oxidative parameters. This result may indicate that schizoaffective disorder could differ from bipolar disorder and schizophrenia in terms of biochemical parameters. Increased TOS levels observed in schizoaffective disorder may suggest poor clinical course and may be an indicator of poor prognosis.

[Sample size calculation in clinical post-marketing evaluation of traditional Chinese medicine].

PubMed

Fu, Yingkun; Xie, Yanming

2011-10-01

In recent years, as the Chinese government and people pay more attention on the post-marketing research of Chinese Medicine, part of traditional Chinese medicine breed has or is about to begin after the listing of post-marketing evaluation study. In the post-marketing evaluation design, sample size calculation plays a decisive role. It not only ensures the accuracy and reliability of post-marketing evaluation. but also assures that the intended trials will have a desired power for correctly detecting a clinically meaningful difference of different medicine under study if such a difference truly exists. Up to now, there is no systemic method of sample size calculation in view of the traditional Chinese medicine. In this paper, according to the basic method of sample size calculation and the characteristic of the traditional Chinese medicine clinical evaluation, the sample size calculation methods of the Chinese medicine efficacy and safety are discussed respectively. We hope the paper would be beneficial to medical researchers, and pharmaceutical scientists who are engaged in the areas of Chinese medicine research.

Cost-effectiveness of home-based care versus hospital care for chronically ill tuberculosis patients, Francistown, Botswana.

PubMed

Moalosi, G; Floyd, K; Phatshwane, J; Moeti, T; Binkin, N; Kenyon, T

2003-09-01

Francistown, Botswana, 1999. To determine the affordability and cost-effectiveness of home-based directly observed therapy (DOT) compared to hospital-based DOT for chronically ill tuberculosis (TB) patients, and to describe the characteristics of patients and their caregivers. Costs for each alternative strategy were analysed from the perspective of the health system and caregivers, in 1998 US dollars. Caregiver costs were assessed using a structured questionnaire administered to a sample of 50 caregivers. Health system costs were assessed using interviews with relevant staff and documentary data such as medical records and expenditure files. These data were used to calculate the average cost of individual components of care, and, for each alternative strategy, the average cost per patient treated. Cost-effectiveness was calculated as the cost per patient compliant with treatment. The characteristics of caregivers and patients were assessed using demographic and socio-economic data collected during interviews, and medical records. Overall, home-based care reduced the cost per patient treated by 44% compared with hospital-based treatment (dollars 1657 vs. dollars 2970). The cost to the caregiver was reduced by 23% (dollars 551 vs. dollars 720), while the cost to the health system was reduced by 50% (dollars 1106 vs. dollars 2206). The cost per patient complying with treatment was dollars 1726 for home-based care and dollars 2970 for hospitalisation. Caregivers were predominantly female relatives (88%), unemployed (48%), with primary school education or less (82%), and with an income of less than dollars 1000 per annum (71%). Of those patients with an HIV test result, 98% were HIV-positive. Home-based care is more affordable and cost-effective than hospital-based care for chronically ill TB patients, although costs to caregivers remain high in relation to their incomes. Structured home-based DOT should be included as a component of the National Tuberculosis Control Programme in Botswana.

Unmet need for specialised rehabilitation following neurosurgery: can we maximise the potential cost-benefits?

PubMed

Singh, Rajiv; Sinha, Saurabh; Bill, Alan; Turner-Stokes, Lynne

2017-04-01

To identify the needs for specialised rehabilitation provision in a cohort of neurosurgical patients; to determine if these were met, and to estimate the potential cost implications and cost-benefits of meeting any unmet rehabilitation needs. A prospective study of in-patient admissions to a regional neurosurgical ward. Assessment of needs for specialised rehabilitation (Category A or B needs) was made with the Patient Categorisation Tool. The number of patients who were referred and admitted for specialised rehabilitation was calculated. Data from the unit's submission to the UK Rehabilitation Outcomes Collaborative (UKROC) national clinical database 2012-2015 were used to estimate the potential mean lifetime savings generated through reduction in the costs of on-going care in the community. Of 223 neurosurgical in-patients over 3 months, 156 (70%) had Category A or B needs. Out of the 105 patients who were eligible for admission to the local specialised rehabilitation service, only 20 (19%) were referred and just 11 (10%) were actually admitted. The mean transfer time was 70.2 (range 28-127) days, compared with the national standard of 42 days. In the 3-year sample, mean savings in the cost of on-going care were £568 per week. Assuming a 10-year reduction in life expectancy, the approximate net lifetime saving for post-neurosurgical patients was estimated as at least £600K per patient. We calculated that provision of additional bed capacity in the specialist rehabilitation unit could generate net savings of £3.6M/bed-year. This preliminary single-centre study identified a considerable gap in provision of specialised rehabilitation for neurosurgical patients, which must be addressed if patients are to fulfil their potential for recovery. A 5-fold increase in bed capacity would cost £9.3m/year, but could lead to potential net savings of £24m/year. Our findings now require confirmation on a wider scale through prospective multi-centre studies.

Variable Linezolid Exposure in Intensive Care Unit Patients-Possible Role of Drug-Drug Interactions.

PubMed

Töpper, Christoph; Steinbach, Cathérine L; Dorn, Christoph; Kratzer, Alexander; Wicha, Sebastian G; Schleibinger, Michael; Liebchen, Uwe; Kees, Frieder; Salzberger, Bernd; Kees, Martin G

2016-10-01

Standard doses of linezolid may not be suitable for all patient groups. Intensive care unit (ICU) patients in particular may be at risk of inadequate concentrations. This study investigated variability of drug exposure and its potential sources in this population. Plasma concentrations of linezolid were determined by high-performance liquid chromatography in a convenience sample of 20 ICU patients treated with intravenous linezolid 600 mg twice daily. Ultrafiltration applying physiological conditions (pH 7.4/37°C) was used to determine the unbound fraction. Individual pharmacokinetic (PK) parameters were estimated by population PK modeling. As measures of exposure to linezolid, area under the concentration-time curve (AUC) and trough concentrations (Cmin) were calculated and compared with published therapeutic ranges (AUC 200-400 mg*h/L, Cmin 2-10 mg/L). Coadministered inhibitors or inducers of cytochrome P450 and/or P-glycoprotein were noted. Data from 18 patients were included into the PK evaluation. Drug exposure was highly variable (median, range: AUC 185, 48-618 mg*h/L, calculated Cmin 2.92, 0.0062-18.9 mg/L), and only a minority of patients had values within the target ranges (6 and 7, respectively). AUC and Cmin were linearly correlated (R = 0.98), and classification of patients (underexposed/within therapeutic range/overexposed) according to AUC or Cmin was concordant in 15 cases. Coadministration of inhibitors was associated with a trend to higher drug exposure, whereas 3 patients treated with levothyroxine showed exceedingly low drug exposure (AUC ∼60 mg*h/L, Cmin <0.4 mg/L). The median unbound fraction in all 20 patients was 90.9%. Drug exposure after standard doses of linezolid is highly variable and difficult to predict in ICU patients, and therapeutic drug monitoring seems advisable. PK drug-drug interactions might partly be responsible and should be further investigated; protein binding appears to be stable and irrelevant.

XAFSmass: a program for calculating the optimal mass of XAFS samples

NASA Astrophysics Data System (ADS)

Klementiev, K.; Chernikov, R.

2016-05-01

We present a new implementation of the XAFSmass program that calculates the optimal mass of XAFS samples. It has several improvements as compared to the old Windows based program XAFSmass: 1) it is truly platform independent, as provided by Python language, 2) it has an improved parser of chemical formulas that enables parentheses and nested inclusion-to-matrix weight percentages. The program calculates the absorption edge height given the total optical thickness, operates with differently determined sample amounts (mass, pressure, density or sample area) depending on the aggregate state of the sample and solves the inverse problem of finding the elemental composition given the experimental absorption edge jump and the chemical formula.

Sample size and power calculations for detecting changes in malaria transmission using antibody seroconversion rate.

PubMed

Sepúlveda, Nuno; Paulino, Carlos Daniel; Drakeley, Chris

2015-12-30

Several studies have highlighted the use of serological data in detecting a reduction in malaria transmission intensity. These studies have typically used serology as an adjunct measure and no formal examination of sample size calculations for this approach has been conducted. A sample size calculator is proposed for cross-sectional surveys using data simulation from a reverse catalytic model assuming a reduction in seroconversion rate (SCR) at a given change point before sampling. This calculator is based on logistic approximations for the underlying power curves to detect a reduction in SCR in relation to the hypothesis of a stable SCR for the same data. Sample sizes are illustrated for a hypothetical cross-sectional survey from an African population assuming a known or unknown change point. Overall, data simulation demonstrates that power is strongly affected by assuming a known or unknown change point. Small sample sizes are sufficient to detect strong reductions in SCR, but invariantly lead to poor precision of estimates for current SCR. In this situation, sample size is better determined by controlling the precision of SCR estimates. Conversely larger sample sizes are required for detecting more subtle reductions in malaria transmission but those invariantly increase precision whilst reducing putative estimation bias. The proposed sample size calculator, although based on data simulation, shows promise of being easily applicable to a range of populations and survey types. Since the change point is a major source of uncertainty, obtaining or assuming prior information about this parameter might reduce both the sample size and the chance of generating biased SCR estimates.

7 CFR 51.308 - Methods of sampling and calculation of percentages.

Code of Federal Regulations, 2012 CFR

2012-01-01

..., CERTIFICATION, AND STANDARDS) United States Standards for Grades of Apples Methods of Sampling and Calculation... where the minimum diameter of the smallest apple does not vary more than 1/2 inch from the minimum diameter of the largest apple, percentages shall be calculated on the basis of count. (b) In all other...

7 CFR 51.308 - Methods of sampling and calculation of percentages.

Code of Federal Regulations, 2011 CFR

2011-01-01

..., CERTIFICATION, AND STANDARDS) United States Standards for Grades of Apples Methods of Sampling and Calculation... where the minimum diameter of the smallest apple does not vary more than 1/2 inch from the minimum diameter of the largest apple, percentages shall be calculated on the basis of count. (b) In all other...

7 CFR 51.308 - Methods of sampling and calculation of percentages.

Code of Federal Regulations, 2010 CFR

2010-01-01

..., CERTIFICATION, AND STANDARDS) United States Standards for Grades of Apples Methods of Sampling and Calculation... where the minimum diameter of the smallest apple does not vary more than 1/2 inch from the minimum diameter of the largest apple, percentages shall be calculated on the basis of count. (b) In all other...

40 CFR 600.211-08 - Sample calculation of fuel economy values for labeling.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 30 2011-07-01 2011-07-01 false Sample calculation of fuel economy... AGENCY (CONTINUED) ENERGY POLICY FUEL ECONOMY AND CARBON-RELATED EXHAUST EMISSIONS OF MOTOR VEHICLES Procedures for Calculating Fuel Economy and Carbon-Related Exhaust Emission Values for 1977 and Later Model...

Nomogram for sample size calculation on a straightforward basis for the kappa statistic.

PubMed

Hong, Hyunsook; Choi, Yunhee; Hahn, Seokyung; Park, Sue Kyung; Park, Byung-Joo

2014-09-01

Kappa is a widely used measure of agreement. However, it may not be straightforward in some situation such as sample size calculation due to the kappa paradox: high agreement but low kappa. Hence, it seems reasonable in sample size calculation that the level of agreement under a certain marginal prevalence is considered in terms of a simple proportion of agreement rather than a kappa value. Therefore, sample size formulae and nomograms using a simple proportion of agreement rather than a kappa under certain marginal prevalences are proposed. A sample size formula was derived using the kappa statistic under the common correlation model and goodness-of-fit statistic. The nomogram for the sample size formula was developed using SAS 9.3. The sample size formulae using a simple proportion of agreement instead of a kappa statistic and nomograms to eliminate the inconvenience of using a mathematical formula were produced. A nomogram for sample size calculation with a simple proportion of agreement should be useful in the planning stages when the focus of interest is on testing the hypothesis of interobserver agreement involving two raters and nominal outcome measures. Copyright © 2014 Elsevier Inc. All rights reserved.

Right parietal cortex and calculation processing: intraoperative functional mapping of multiplication and addition in patients affected by a brain tumor.

PubMed

Della Puppa, Alessandro; De Pellegrin, Serena; d'Avella, Elena; Gioffrè, Giorgio; Munari, Marina; Saladini, Marina; Salillas, Elena; Scienza, Renato; Semenza, Carlo

2013-11-01

The role of parietal areas in number processing is well known. The significance of intraoperative functional mapping of these areas has been only partially explored, however, and only a few discordant data are available in the surgical literature with regard to the right parietal lobe. The purpose of this study was to evaluate the clinical impact of simple calculation in cortical electrostimulation of right-handed patients affected by a right parietal brain tumor. Calculation mapping in awake surgery was performed in 3 right-handed patients affected by high-grade gliomas located in the right parietal lobe. Preoperatively, none of the patients presented with calculation deficits. In all 3 cases, after sensorimotor and language mapping, cortical and intraparietal sulcus areas involved in single-digit multiplication and addition calculations were mapped using bipolar electrostimulation. In all patients, different sites of the right parietal cortex, mainly in the inferior lobule, were detected as being specifically related to calculation (multiplication or addition). In 2 patients the intraparietal sulcus was functionally specific for multiplication. No functional sites for language were detected. All sites functional for calculation were spared during tumor resection, which was complete in all cases without postoperative neurological deficits. These findings provide intraoperative data in support of an anatomofunctional organization for multiplication and addition within the right parietal area. Furthermore, the study shows the potential clinical relevance of intraoperative mapping of calculation in patients undergoing surgery in the right parietal area. Further and larger studies are needed to confirm these data and assess whether mapped areas are effectively essential for function.

A wireless breathing-training support system for kinesitherapy.

PubMed

Tawa, Hiroki; Yonezawa, Yoshiharu; Maki, Hiromichi; Ogawa, Hidekuni; Ninomiya, Ishio; Sada, Kouji; Hamada, Shingo; Caldwell, W Morton

2009-01-01

We have developed a new wireless breathing-training support system for kinesitherapy. The system consists of an optical sensor, an accelerometer, a microcontroller, a Bluetooth module and a laptop computer. The optical sensor, which is attached to the patient's chest, measures chest circumference. The low frequency components of circumference are mainly generated by breathing. The optical sensor outputs the circumference as serial digital data. The accelerometer measures the dynamic acceleration force produced by exercise, such as walking. The microcontroller sequentially samples this force. The acceleration force and chest circumference are sent sequentially via Bluetooth to a physical therapist's laptop computer, which receives and stores the data. The computer simultaneously displays these data so that the physical therapist can monitor the patient's breathing and acceleration waveforms and give instructions to the patient in real time during exercise. Moreover, the system enables a quantitative training evaluation and calculation the volume of air inspired and expired by the lungs.

Evaluation of the Goldmann-Witmer coefficient in the immunological diagnosis of ocular toxocariasis.

PubMed

Wang, Zhu Jian; Zhou, Min; Cao, Wen Jun; Ji, Jian; Bi, Ying Wen; Huang, Xin; Xu, Ge Zhi

2016-06-01

Ocular toxocariasis (OT) is a zoonotic parasitic infection mainly caused by the intraocular tissue invasion of second-stage Toxocara canis or Toxocara cati larva. Measuring specific anti-T. canis antibodies in the intraocular fluid (IF) can increase OT diagnosis accuracy using Goldmann-Witmer coefficient (GWC). However, there is no systemic evaluation of GWC application in the immunological diagnosis of OT. To assess GWC for the immunodiagnosis of ocular toxocariasis, paired IF and serum samples from 72 patients diagnosed with OT were retrospectively analyzed for specific anti-T. canis IgG by enzyme linked immunosorbent assay (ELISA). GWC values were calculated to determine intraocular specific IgG production. Clinical features and other laboratory data were recorded, and their correlations with GWC evaluated. Of the 72 OT patients, 60 (83.33%) showed intraocular specific IgG production confirmed by GWC, while intraocular nonspecific IgE production was found in 64/69 (92.75%) cases. No significant correlation was found among clinical features and IF specific IgG production. Values for peripheral blood samples were lower than those of intraocular fluid regarding OT screening, and vitreous humor samples showed increased local specific IgG and nonspecific IgE production compared with aqueous humor samples. Overall, our results indicate that GWC and intraocular IgE production have referential values in diagnosing ocular toxocariasis. Copyright © 2016 Elsevier B.V. All rights reserved.

Ambulatory Blood Pressure Monitoring Profile as a Useful Prognostic Tool in Patients with Primary Hypertension

PubMed Central

Mohamed, A. L.; Katiman, E; Hassan, J Abu

2003-01-01

Ambulatory blood pressure monitoring (ABPM) devices are increasingly being used in the assessment of hypertension. The purpose of the study was to investigate patient’s diurnal BP variation and to further determine the differences of BP readings between male and female patients and the effects of age in patients who attended the clinic with essential hypertension. In addition, evidence of relationship between the parameters recorded by 24-hour ABPM was also investigated. This study was conducted in an outpatient specialist clinic. Two indices were used to demonstrate the diurnal BP variation. Firstly, the diurnal systolic blood pressure (SBP) and diastolic blood pressure (DBP) variations which were calculated as night/day BP ratio for SBP and DBP respectively. Anyone scoring less than 100% were categorised as dippers. Secondly, nocturnal falls in SBP and DBP were calculated as (awake SBP-sleep SBP)/awake SBP x 100 and (awake DBP-sleep DBP)/awake DBP x 100 respectively. The results showed that there was no significant difference in the mean BP between male and female patients. In general, the study sample were categorised as dippers and non dippers. There were more male dippers than female dippers. Finally correlation analysis revealed that age is related to SBP variables whilst night HR showed positive correlation with night time BP. It is concluded that ABPM was shown to be a useful tool to analyse the variation and prevalence of cardiovascular risk markers in hypertensive patients and can easily be done in an outpatient set-up. PMID:23386801

Comorbid subjective health complaints in patients with sciatica: a prospective study including comparison with the general population.

PubMed

Grøvle, Lars; Haugen, Anne J; Ihlebaek, Camilla M; Keller, Anne; Natvig, Bård; Brox, Jens I; Grotle, Margreth

2011-06-01

Chronic nonspecific low back pain is accompanied by high rates of comorbid mental and physical conditions. The aims of this study were to investigate if patients with specific back pain, that is, sciatica caused by lumbar herniation, report higher rates of subjective health complaints (SHCs) than the general population and if there is an association between change in sciatica symptoms and change in SHCs over a 12-month period. A multicenter cohort study of 466 sciatica patients was conducted with follow-up at 3 months and 1 year. Comorbid SHCs were measured by 27 items of the SHC inventory. Odds ratios (ORs) for each SHC were calculated with comparison to a general population sample (n=928) by logistic regression. The SHC number was calculated by summing all complaints present. At baseline, the ORs for reporting SHCs for the sciatica patients were significantly elevated in 15 of the 27 items with a mean (S.D.) SHC number of 7.5 (4.4), compared to 5.2 (4.4) in the general population (P<.01). Among those who during the 1-year follow-up period fully recovered from their sciatica, the SHC number was reduced to normal levels. Among those with persisting or worsening sciatica, the number increased to a level almost double that of the general population. Compared to the general population, the prevalence of subjective health complaints in sciatica is increased. During follow-up, the number of health complaints increased in patients with persisting or worsening sciatica. Copyright © 2010 Elsevier Inc. All rights reserved.

Abdominal 64-MDCT for suspected appendicitis: the use of oral and IV contrast material versus IV contrast material only.

PubMed

Anderson, Stephan W; Soto, Jorge A; Lucey, Brian C; Ozonoff, Al; Jordan, Jacqueline D; Ratevosian, Jirair; Ulrich, Andrew S; Rathlev, Niels K; Mitchell, Patricia M; Rebholz, Casey; Feldman, James A; Rhea, James T

2009-11-01

The objective of our study was to compare the diagnostic accuracy of IV contrast-enhanced 64-MDCT with and without the use of oral contrast material in diagnosing appendicitis in patients with abdominal pain. We conducted a randomized trial of a convenience sample of adult patients presenting to an urban academic emergency department with acute nontraumatic abdominal pain and clinical suspicion of appendicitis, diverticulitis, or small-bowel obstruction. Patients were enrolled between 8 am and 11 pm when research assistants were present. Consenting subjects were randomized into one of two groups: Group 1 subjects underwent 64-MDCT performed with oral and IV contrast media and group 2 subjects underwent 64-MDCT performed solely with IV contrast material. Three expert radiologists independently reviewed the CT examinations, evaluating for the presence of appendicitis. Each radiologist interpreted 202 examinations, ensuring that each examination was interpreted by two radiologists. Individual reader performance and a combined interpretation performance of the two readers assigned to each case were calculated. In cases of disagreement, the third reader was asked to deliver a tiebreaker interpretation to be used to calculate the combined reader performance. Final outcome was based on operative, clinical, and follow-up data. We compared radiologic diagnoses with clinical outcomes to calculate the diagnostic accuracy of CT in both groups. Of the 303 patients enrolled, 151 patients (50%) were randomized to group 1 and the remaining 152 (50%) were randomized to group 2. The combined reader performance for the diagnosis of appendicitis in group 1 was a sensitivity of 100% (95% CI, 76.8-100%) and specificity of 97.1% (95% CI, 92.7-99.2%). The performance in group 2 was a sensitivity of 100% (73.5-100%) and specificity of 97.1% (92.9-99.2%). Patients presenting with nontraumatic abdominal pain imaged using 64-MDCT with isotropic reformations had similar characteristics for the diagnosis of appendicitis when IV contrast material alone was used and when oral and IV contrast media were used.

Outcomes and Safety of the Combined Abdominoplasty-Hysterectomy: A Preliminary Study.

PubMed

Massenburg, Benjamin B; Sanati-Mehrizy, Paymon; Ingargiola, Michael J; Rosa, Jonatan Hernandez; Taub, Peter J

2015-10-01

Abdominoplasty (ABP) at the time of hysterectomy (HYS) has been described in the literature since 1986 and is being increasingly requested by patients. However, outcomes of the combined procedure have not been thoroughly explored. The authors reviewed the American College of Surgeons National Surgical Quality Improvement Program database and identified each ABP, HYS, and combined ABP-HYS performed between 2005 and 2012. The incidence of complications in each of the three procedures was calculated, and a multiplicative-risk model was used to calculate the probability of a complication for a patient undergoing distinct HYS and ABP on different dates. One-sample binomial hypothesis tests were performed to determine statistical significance. There were 1325 ABP cases, 12,173 HYS cases, and 143 ABP-HYS cases identified. Surgical complications occurred in 7.7 % of patients undergoing an ABP-HYS, while the calculated risk of a surgical complication was 12.5 % (p = 0.0407) for patients undergoing separate ABP and HYS procedures. The mean operative time was significantly lower for an ABP-HYS at 238 vs. 270 min for separate ABP and HYS procedures (p < 0.0001), and the mean time under anesthesia was significantly lower at 295 vs. 364 min (p < 0.0001). A combined ABP-HYS has a lower incidence of surgical complications than separate ABP and HYS procedures performed on different dates. These data should not encourage all patients to elect a combined ABP-HYS, if only undergoing a HYS, as the combined procedure is associated with increased risks when compared to either isolated individual procedure. However, in patients who are planning on undergoing both procedures on separate dates, a combined ABP-HYS is a safe option that will result in fewer surgical complications, less operative time, less time under anesthesia, and a trend towards fewer days in the hospital. This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Systematic review finds major deficiencies in sample size methodology and reporting for stepped-wedge cluster randomised trials

PubMed Central

Martin, James; Taljaard, Monica; Girling, Alan; Hemming, Karla

2016-01-01

Background Stepped-wedge cluster randomised trials (SW-CRT) are increasingly being used in health policy and services research, but unless they are conducted and reported to the highest methodological standards, they are unlikely to be useful to decision-makers. Sample size calculations for these designs require allowance for clustering, time effects and repeated measures. Methods We carried out a methodological review of SW-CRTs up to October 2014. We assessed adherence to reporting each of the 9 sample size calculation items recommended in the 2012 extension of the CONSORT statement to cluster trials. Results We identified 32 completed trials and 28 independent protocols published between 1987 and 2014. Of these, 45 (75%) reported a sample size calculation, with a median of 5.0 (IQR 2.5–6.0) of the 9 CONSORT items reported. Of those that reported a sample size calculation, the majority, 33 (73%), allowed for clustering, but just 15 (33%) allowed for time effects. There was a small increase in the proportions reporting a sample size calculation (from 64% before to 84% after publication of the CONSORT extension, p=0.07). The type of design (cohort or cross-sectional) was not reported clearly in the majority of studies, but cohort designs seemed to be most prevalent. Sample size calculations in cohort designs were particularly poor with only 3 out of 24 (13%) of these studies allowing for repeated measures. Discussion The quality of reporting of sample size items in stepped-wedge trials is suboptimal. There is an urgent need for dissemination of the appropriate guidelines for reporting and methodological development to match the proliferation of the use of this design in practice. Time effects and repeated measures should be considered in all SW-CRT power calculations, and there should be clarity in reporting trials as cohort or cross-sectional designs. PMID:26846897

Design and patient characteristics of ESHOL study, a Catalonian prospective randomized study.

PubMed

Maduell, Francisco; Moreso, Francesc; Pons, Mercedes; Ramos, Rosa; Mora-Macià, Josep; Foraster, Andreu; Soler, Jordi; Galceran, Josep M; Martinez-Castelao, Alberto

2011-01-01

Retrospective studies showed that online hemodiafiltration (OL-HDF) is associated with a risk reduction of mortality over standard hemodialysis (HD) in patients with end-stage renal disease. Until now, no information was available from prospective randomized clinical trials. A prospective, randomized, multicenter, open study was designed to be conducted in HD units from Catalonia (Spain). The aim of the study is to compare 3-year survival in prevalent end-stage renal disease patients randomized to OL-HDF or to continue on standard HD. The minimum sample size was calculated according to Catalonian mortality of patients on dialysis and assuming a risk reduction associated with OL-HDF of 35% (1-sided p<0.05 and a statistical power of 0.8) and a rate of dropout due to renal transplantation or loss to follow-up of 30%. From May 2007 to September 2008, 906 patients were included and randomized to OL-HDF (n=456) or standard HD (n=450). Demographics and analytical data at the time of randomization were not different between both groups of patients. Patients will be followed during a 3-year period. The present study will contribute to evaluating the benefit for patient survival of OL-HDF over standard HD.

Standard Deviation for Small Samples

ERIC Educational Resources Information Center

Joarder, Anwar H.; Latif, Raja M.

2006-01-01

Neater representations for variance are given for small sample sizes, especially for 3 and 4. With these representations, variance can be calculated without a calculator if sample sizes are small and observations are integers, and an upper bound for the standard deviation is immediate. Accessible proofs of lower and upper bounds are presented for…

SU-F-T-67: Correction Factors for Monitor Unit Verification of Clinical Electron Beams

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

Haywood, J

Purpose: Monitor units calculated by electron Monte Carlo treatment planning systems are often higher than TG-71 hand calculations for a majority of patients. Here I’ve calculated tables of geometry and heterogeneity correction factors for correcting electron hand calculations. Method: A flat water phantom with spherical volumes having radii ranging from 3 to 15 cm was created. The spheres were centered with respect to the flat water phantom, and all shapes shared a surface at 100 cm SSD. D{sub max} dose at 100 cm SSD was calculated for each cone and energy on the flat phantom and for the spherical volumesmore » in the absence of the flat phantom. The ratio of dose in the sphere to dose in the flat phantom defined the geometrical correction factor. The heterogeneity factors were then calculated from the unrestricted collisional stopping power for tissues encountered in electron beam treatments. These factors were then used in patient second check calculations. Patient curvature was estimated by the largest sphere that aligns to the patient contour, and appropriate tissue density was read from the physical properties provided by the CT. The resulting MU were compared to those calculated by the treatment planning system and TG-71 hand calculations. Results: The geometry and heterogeneity correction factors range from ∼(0.8–1.0) and ∼(0.9–1.01) respectively for the energies and cones presented. Percent differences for TG-71 hand calculations drop from ∼(3–14)% to ∼(0–2)%. Conclusion: Monitor units calculated with the correction factors typically decrease the percent difference to under actionable levels, < 5%. While these correction factors work for a majority of patients, there are some patient anatomies that do not fit the assumptions made. Using these factors in hand calculations is a first step in bringing the verification monitor units into agreement with the treatment planning system MU.« less

A tool to determine financial impact of adverse events in health care: healthcare quality calculator.

PubMed

Yarbrough, Wendell G; Sewell, Andrew; Tickle, Erin; Rhinehardt, Eric; Harkleroad, Rod; Bennett, Marc; Johnson, Deborah; Wen, Li; Pfeiffer, Matthew; Benegas, Manny; Morath, Julie

2014-12-01

Hospital leaders lack tools to determine the financial impact of poor patient outcomes and adverse events. To provide health-care leaders with decision support for investments to improve care, we created a tool, the Healthcare Quality Calculator (HQCal), which uses institution-specific financial data to calculate impact of poor patient outcomes or quality improvement on present and future margin. Excel and Web-based versions of the HQCal were based on a cohort study framework and created with modular components including major drivers of cost and reimbursement. The Healthcare Quality Calculator (HQCal) compares payment, cost, and profit/loss for patients with and without poor outcomes or quality issues. Cost and payment information for groups with and without quality issues are used by the HQCal to calculate profit or loss. Importantly, institution-specific payment and cost data are used to calculate financial impact and attributable cost associated with poor patient outcomes, adverse events, or quality issues. Because future cost and reimbursement changes can be forecast, the HQCal incorporates a forward-looking component. The flexibility of the HQCal was demonstrated using surgical site infections after abdominal surgery and postoperative surgical airway complications. The Healthcare Quality Calculator determines financial impact of poor patient outcomes and the benefit of initiatives to improve quality. The calculator can identify quality issues that would provide the largest financial benefit if improved; however, it cannot identify specific interventions. The calculator provides a tool to improve transparency regarding both short- and long-term financial consequences of funding, or failing to fund, initiatives to close gaps in quality or improve patient outcomes.

Comparison of a 3-D multi-group SN particle transport code with Monte Carlo for intracavitary brachytherapy of the cervix uteri.

PubMed

Gifford, Kent A; Wareing, Todd A; Failla, Gregory; Horton, John L; Eifel, Patricia J; Mourtada, Firas

2009-12-03

A patient dose distribution was calculated by a 3D multi-group S N particle transport code for intracavitary brachytherapy of the cervix uteri and compared to previously published Monte Carlo results. A Cs-137 LDR intracavitary brachytherapy CT data set was chosen from our clinical database. MCNPX version 2.5.c, was used to calculate the dose distribution. A 3D multi-group S N particle transport code, Attila version 6.1.1 was used to simulate the same patient. Each patient applicator was built in SolidWorks, a mechanical design package, and then assembled with a coordinate transformation and rotation for the patient. The SolidWorks exported applicator geometry was imported into Attila for calculation. Dose matrices were overlaid on the patient CT data set. Dose volume histograms and point doses were compared. The MCNPX calculation required 14.8 hours, whereas the Attila calculation required 22.2 minutes on a 1.8 GHz AMD Opteron CPU. Agreement between Attila and MCNPX dose calculations at the ICRU 38 points was within +/- 3%. Calculated doses to the 2 cc and 5 cc volumes of highest dose differed by not more than +/- 1.1% between the two codes. Dose and DVH overlays agreed well qualitatively. Attila can calculate dose accurately and efficiently for this Cs-137 CT-based patient geometry. Our data showed that a three-group cross-section set is adequate for Cs-137 computations. Future work is aimed at implementing an optimized version of Attila for radiotherapy calculations.

Comparison of a 3D multi‐group SN particle transport code with Monte Carlo for intercavitary brachytherapy of the cervix uteri

PubMed Central

Wareing, Todd A.; Failla, Gregory; Horton, John L.; Eifel, Patricia J.; Mourtada, Firas

2009-01-01

A patient dose distribution was calculated by a 3D multi‐group SN particle transport code for intracavitary brachytherapy of the cervix uteri and compared to previously published Monte Carlo results. A Cs‐137 LDR intracavitary brachytherapy CT data set was chosen from our clinical database. MCNPX version 2.5.c, was used to calculate the dose distribution. A 3D multi‐group SN particle transport code, Attila version 6.1.1 was used to simulate the same patient. Each patient applicator was built in SolidWorks, a mechanical design package, and then assembled with a coordinate transformation and rotation for the patient. The SolidWorks exported applicator geometry was imported into Attila for calculation. Dose matrices were overlaid on the patient CT data set. Dose volume histograms and point doses were compared. The MCNPX calculation required 14.8 hours, whereas the Attila calculation required 22.2 minutes on a 1.8 GHz AMD Opteron CPU. Agreement between Attila and MCNPX dose calculations at the ICRU 38 points was within ±3%. Calculated doses to the 2 cc and 5 cc volumes of highest dose differed by not more than ±1.1% between the two codes. Dose and DVH overlays agreed well qualitatively. Attila can calculate dose accurately and efficiently for this Cs‐137 CT‐based patient geometry. Our data showed that a three‐group cross‐section set is adequate for Cs‐137 computations. Future work is aimed at implementing an optimized version of Attila for radiotherapy calculations. PACS number: 87.53.Jw

Predictive performance of the 'Minto' remifentanil pharmacokinetic parameter set in morbidly obese patients ensuing from a new method for calculating lean body mass.

PubMed

La Colla, Luca; Albertin, Andrea; La Colla, Giorgio; Porta, Andrea; Aldegheri, Giorgio; Di Candia, Domenico; Gigli, Fausto

2010-01-01

In a previous article, we showed that the pharmacokinetic set of remifentanil used for target-controlled infusion (TCI) might be biased in obese patients because it incorporates flawed equations for the calculation of lean body mass (LBM), which is a covariate of several pharmacokinetic parameters in this set. The objectives of this study were to determine the predictive performance of the original pharmacokinetic set, which incorporates the James equation for LBM calculation, and to determine the predictive performance of the pharmacokinetic set when a new method to calculate LBM was used (the Janmahasatian equations). This was an observational study with intraoperative observations and no follow-up. Fifteen morbidly obese inpatients scheduled for bariatric surgery were included in the study. The intervention included manually controlled continuous infusion of remifentanil during the surgery and analysis of arterial blood samples to determine the arterial remifentanil concentration, to be compared with concentrations predicted by either the unadjusted or the adjusted pharmacokinetic set. The statistical analysis included parametric and non-parametric tests on continuous variables and determination of the median performance error (MDPE), median absolute performance error (MDAPE), divergence and wobble. The median values (interquartile ranges) of the MDPE, MDAPE, divergence and wobble for the James equations during maintenance were -53.4% (-58.7% to -49.2%), 53.4% (49.0-58.7%), 3.3% (2.9-4.7%) and 1.4% h(-1) (1.1-2.5% h(-1)), respectively. The respective values for the Janmahasatian equations were -18.9% (-24.2% to -10.4%), 20.5% (13.3-24.8%), 2.6% (-0.7% to 4.5%) and 1.9% h(-1) (1.4-3.0% h(-1)). The performance (in terms of the MDPE and MDAPE) of the corrected pharmacokinetic set was better than that of the uncorrected one. The predictive performance of the original pharmacokinetic set is not clinically acceptable. Use of a corrected LBM value in morbidly obese patients corrects this pharmacokinetic set and allows its use in obese patients. The 'fictitious height' can be a valid alternative for use of TCI infusion of remifentanil in morbidly obese patients until commercially available infusion pumps and research software are updated and new LBM equations are implemented in their algorithms.

Patient-Specific Instrumentation Affects Perioperative Blood Loss in Total Knee Arthroplasty.

PubMed

Cucchi, Davide; Menon, Alessandra; Zanini, Beatrice; Compagnoni, Riccardo; Ferrua, Paolo; Randelli, Pietro

2018-05-23

Patient-specific instrumentation (PSI) may contribute to reduced blood loss related to total knee arthroplasty (TKA). The purpose of this study was to compare the estimated hemoglobin (Hb) and red blood cell volume (RBC) losses in two groups of patients undergoing TKA with PSI and conventional instrumentation. Pre- and postoperative blood samples were collected from 22 patients randomly assigned to receive a PSI-assisted or conventional TKA. Post- to preoperative Hb difference was calculated and RBC loss was estimated according to Sehat et al. A significant difference in Hb reduction in favor of the PSI group was registered on the last day of stay ( p  = 0.0084) and significant treatment effect ( p  = 0.027) on Hb reduction after intervention was found with a regression model for longitudinal measurements. This study demonstrated that PSI leads to a significant trend in earlier Hb regain. These promising results suggest a beneficial effect of PSI in blood loss reduction. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Cost-effectiveness analysis of individualized mycophenolate mofetil dosing in kidney transplant patients in the APOMYGRE trial.

PubMed

Rousseau, Annick; Laroche, Marie-Laure; Venisse, Nicolas; Loichot-Roselmac, Cecile; Turcant, Alain; Hoizey, Guillaume; Compagnon, Patricia; Hary, Lionel; Debruyne, Danièle; Saivin, Sylvie; Jacqz-Aigrain, Evelyne; Buchler, Mathias; Villeneuve, Claire; Vergnenègre, Alain; Le Meur, Yannick; Marquet, Pierre

2010-05-27

In the prospective, randomized, multicenter APOMYGRE trial conducted in France, concentration-controlled mycophenolate mofetil (MMF) dosing based on mycophenolic acid (MPA) exposure significantly reduced the treatment failure and acute rejection during the first posttransplantation year compared with fixed-dose MMF. This analysis investigated the cost effectiveness of dose individualization. The study included 65 patients per group (intent-to-treat population). Treatment failure (primary efficacy endpoint) was defined as death, graft loss, acute rejection, or MMF discontinuation because of adverse effects. Data on hospitalizations, drugs prescribed, physicians' fees, laboratory expenses, ambulatory visits, and transportation were retrieved. Costs were calculated from the French National Health System perspective. The mean (95% confidence interval) total yearly cost per patient was Euro 47,477 (Euro 43,933; Euro 51,020) in the concentration-controlled group and Euro 46,783 ( Euro 44,152; Euro 49,414) in the fixed-dose group (P=0.7). The observed incremental cost-effectiveness ratio was Euro 3757 per treatment failure (Purchasing Power Parities United States/France: $4129). Hospitalization and drug costs accounted for approximately 50% and 25% of total costs, respectively. The cost for MPA area under the concentration-time curve and dose calculation was Euro 452 per patient, less than 1% of the total cost. In the APOMYGRE trial, therapeutic MPA monitoring using a limited sampling strategy reduced the risk of treatment failure and acute rejection in renal allograft recipients during the first 12 months posttransplantation, at neutral cost.

Effectiveness of different rescanning techniques for scanned proton radiotherapy in lung cancer patients

NASA Astrophysics Data System (ADS)

Engwall, E.; Glimelius, L.; Hynning, E.

2018-05-01

Non-small cell lung cancer (NSCLC) is a tumour type thought to be well-suited for proton radiotherapy. However, the lung region poses many problems related to organ motion and can for actively scanned beams induce severe interplay effects. In this study we investigate four mitigating rescanning techniques: (1) volumetric rescanning, (2) layered rescanning, (3) breath-sampled (BS) layered rescanning, and (4) continuous breath-sampled (CBS) layered rescanning. The breath-sampled methods will spread the layer rescans over a full breathing cycle, resulting in an improved averaging effect at the expense of longer treatment times. In CBS, we aim at further improving the averaging by delivering as many rescans as possible within one breathing cycle. The interplay effect was evaluated for 4D robustly optimized treatment plans (with and without rescanning) for seven NSCLC patients in the treatment planning system RayStation. The optimization and final dose calculation used a Monte Carlo dose engine to account for the density heterogeneities in the lung region. A realistic treatment delivery time structure given from the IBA ScanAlgo simulation tool served as basis for the interplay evaluation. Both slow (2.0 s) and fast (0.1 s) energy switching times were simulated. For all seven studied patients, rescanning improves the dose conformity to the target. The general trend is that the breath-sampled techniques are superior to layered and volumetric rescanning with respect to both target coverage and variability in dose to OARs. The spacing between rescans in our breath-sampled techniques is set at planning, based on the average breathing cycle length obtained in conjunction with CT acquisition. For moderately varied breathing cycle lengths between planning and delivery (up to 15%), the breath-sampled techniques still mitigate the interplay effect well. This shows the potential for smooth implementation at the clinic without additional motion monitoring equipment.

Design of Indigenous ELISA Using Tachyzoites from the RH Strain of Toxoplasma gondii and Comparison with Commercial Kits in Ahvaz, Southwest of Iran, 2015.

PubMed

Mohammadpour, Niloofar; Saki, Jasem; Rafiei, Abdollah; Khodadadi, Ali; Tavalla, Mehdi; Cheraghian, Bahman

2016-10-01

Toxoplasma gondii is one of the most common causes of latent infections in humans worldwide. Detecting anti- Toxoplasma antibodies in serum using serological tests is a common method to diagnose toxoplasmosis. In the present study, an indigenous ELISA kit was prepared using tachyzoites from the RH strain of T. gondii , and its sensitivity and specificity were compared with those of commercial kits. To produce antigens, 0.02 mL of locally isolated T. gondii RH strain parasites along with 10 9 tachyzoites were injected into the peritoneal cavities of 50 laboratory mice (BALB/C). Parasites were collected after 4 days. After filtering and washing, the concentration of protein in sonicated tachyzoites was calculated using the Lowry protein assay. The dilution of antigen, serum and alkaline phosphatase conjugate was assessed in designing an indigenous ELISA method; then ELISA was performed based on these dilutions, and its sensitivity was determined using 200 serum samples. In addition, the specificity of the assay was evaluated using 40 serum samples from patients with tuberculosis, leukemia or hydatid cyst. Indigenous ELISA was used to examine 100 serum samples containing anti- T. gondii IgG, with a sensitivity of 98% (commercial kits: 100%). Another 100 serum samples containing anti- T. gondii IgM were also tested, with a sensitivity of 99% (commercial kits: 100%). When 40 serum samples from patients with leukemia, hydatid cyst or tuberculosis were examined using anti- T. gondii IgG, the specificity was 100%, identical to commercial kits. However, the specificity of a similar test with anti- T. gondii IgM was just 28.6% for serum samples from leukemia patients, 21.4% for hydatid cyst and 16.7% for tuberculosis. We found that purified locally isolated soluble crude antigens of the RH strain of T. gondii from the peritoneal cavity of mice may be one of the most promising antigens for detection of human toxoplasmosis in routine screening.

An Inventory of Aquatic Macroinvertebrates and Calculation of Selected Biotic Indices for the U.S. Army Atterbury Reserve Forces Training Area near Edinburgh, Indiana, September 2000 - August 2002

USGS Publications Warehouse

Robinson, Bret A.

2004-01-01

Biotic indices (indicators of water-quality conditions) were calculated from the macroinvertebrate data. Ephemeroptera, Plecoptera, Trichoptera Richness Index values calculated for 23 samples collected from 16 sites ranged from 5 to 15, with more than 75 percent of the values falling within the range of 7 to 11. Hilsenhoff Biotic Index scores and Invertebrate Community Index scores calculated for samples collected at three sites indicate that water quality at these sites ranged from good to poor. The one site with a poor water-quality index score had a small drainage area. The small drainage area and dry conditions during the sampling period may have contributed to the poor scores calculated for this site.

Racial disparities in age at time of cardiovascular events and cardiovascular-related death in patients with systemic lupus erythematosus.

PubMed

Scalzi, Lisabeth V; Hollenbeak, Christopher S; Wang, Li

2010-09-01

To determine whether racial disparities exist with regard to the age at which patients with systemic lupus erythematosus (SLE) experience cardiovascular disease (CVD) and CVD-associated death. Using the 2003-2006 Nationwide Inpatient Sample, we calculated the age difference between patients with SLE and their race- and sex-matched controls at the time of hospitalization for a cardiovascular event and for CVD-associated death. In addition, we calculated the age difference between white patients with SLE and sex-matched controls for each minority group for the same outcomes. The mean age difference between women with and those without SLE at the time of admission for a CVD event was 10.5 years. All age differences between women with SLE (n = 3,627) and women without SLE admitted for CVD were significant (P < 0.0001). Among different racial groups with SLE, black women were the youngest to be admitted with CVD (53.9 years) and to have a CVD-associated in-hospital death (52.8 years; n = 218). Black women with SLE were 19.8 years younger than race- and sex-matched controls at the time of CVD-associated death. Admission trends for CVD were reversed for black women, such that the highest proportions of these patients were admitted before age 55 years, and then the proportions steadily decreased across age categories. Among the 805 men with SLE who were admitted with a CVD event, those who were black or Hispanic were youngest. There are significant racial disparities with regard to age at the time of hospital admission for CVD events and CVD-related hospitalization resulting in death in patients with SLE.

Hospitalization and catastrophic medical payment: evidence from hospitals located in Tehran.

PubMed

Ghiasvand, Hesam; Sha'baninejad, Hossein; Arab, Mohammad; Rashidian, Arash

2014-07-01

Hospitalized patients constitute the main fraction of users in any health system. Financial burden of reimbursement for received services and cares by these users is sometimes unbearable and may lead to catastrophic medical payments. So, designing and implementing effective health prepayments schemes appear to be an effective governmental intervention to reduce catastrophic medical payments and protect households against it. We aimed to calculate the proportion of hospitalized patients exposed to catastrophic medical payments, its determinant factors and its distribution. We conducted a cross sectional study with 400 samples in five hospitals affiliated with Tehran University of Medical Sciences (TUMS). A self-administered questionnaire was distributed among respondents. Data were analyzed by logistic regression and χ(2) statistics. Also, we drew the Lorenz curve and calculated the Gini coefficient in order to present the distribution of catastrophic medical payments burden on different income levels. About 15.05% of patients were exposed to catastrophic medical payments. Also, we found that the educational level of the patient's family head, the sex of the patient's family head, hospitalization day numbers, having made any out of hospital payments linked with the same admission and households annual income levels; were linked with a higher likelihood of exposure to catastrophic medical payments. Also, the Gini coefficient is about 0.8 for catastrophic medical payments distribution. There is a high level of catastrophic medical payments in hospitalized patients. The weakness of economic status of households and the not well designed prepayments schemes on the other hand may lead to this. This paper illustrated a clear picture for catastrophic medical payments at hospital level and suggests applicable notes to Iranian health policymakers and planners.

Development of an enzymatic assay to measure lactate in perchloric acid-precipitated cerebrospinal fluid.

PubMed

Lu, Jun; Genzen, Jonathan R; Grenache, David G

2018-04-27

Individuals with inherited deficiencies of the pyruvate dehydrogenase complex or the respiratory chain complex can have increased concentrations of cerebrospinal fluid (CSF) lactate. Such measurements are clinical useful when measured in conjunction with pyruvate in order to calculate the lactate:pyruvate (L:P) ratio, a useful surrogate of cytosolic redox status. CSF pyruvate is measured in a protein-free supernatant prepared by the addition of CSF to perchloric acid while lactate is measured in untreated CSF. Utilizing the same sample for both lactate and pyruvate measurements is desirable. To develop a method to measure lactate in perchloric-acid precipitated CSF and validate the L:P ratio as calculated from the analysis of both analytes in the same sample. Samples were prepared by the addition of 1 mL CSF to 2 mL 8% (w/v) cold perchloric acid, incubated on ice for 10 min, then centrifuged to obtain a protein-free supernatant. Lactate was measured by its oxidation to pyruvate and hydrogen peroxide using lactate oxidase and the absorbance of the resulting chromogen determined at 540 nm on a Roche cobas c501 chemistry analyzer. Method accuracy, linearity, imprecision and sensitivity were determined and a reference interval was verified. To assess accuracy, this method was compared to lactate determined in unaltered CSF at another laboratory using 41 specimens with lactate concentrations from 0.6-11.9 mmol/L. Linear regression produced a slope of 1.09 and y-intercept of 0.26 (R 2  = 1.00). Recovery was performed by ad-mixes of a high lactate standard and a CSF pool in different ratios to create a set of 19 samples prior to preparing protein-free supernatants. Recovery was 94.6-100% (mean ± SD was 97.4 ± 1.4%) at lactate concentrations of 2.68 to 12.63 mmol/L. Linearity was determined by combining two supernatants with low and high lactate concentrations in different ratios to create a set of six samples (0.15-12.70 mmol/L) that were tested in duplicate. Linear regression generated a slope of 1.01, y-intercept of -0.04 (R 2  = 1.00). Precision was verified by analyzing quality control materials (acid-treated lactate standard) in 3 replicates each day for 5 days. Within-laboratory imprecision was 2.3% at 1.5 mmol/L and 1.5% at 10.5 mmol/L. The limit of blank was 0.05 mmol/L as determined by the mean added to three standard deviations determined from 10 replicates of perchloric-acid treated saline pool. The limit of detection was determined to be 0.12 mmol/L calculated from 10 replicates of a patient sample treated with perchloric-acid. The manufacturer's reference interval of 1.1-2.4 mmol/L was verified using 20 residual patient CSF samples. CSF lactate can be measured with accuracy and precision using the same perchloric-acid treated sample that is used for pyruvate. Copyright © 2018 Elsevier B.V. All rights reserved.