How do we achieve blinding in modern electronic and paper medical records during the conduct of transfusion trials?

BACKGROUND: Regulatory aspects of transfusion medicine add complexity in blinded transfusion trials when considering various electronic record keeping software and blood administration processes. The aim of this study is to explore strategies when blinding transfusion components and products in paper and electronic medical records. METHODS: Surveys were collected and interviews were conducted for 18 sites across various jurisdictions in North America to determine solutions applied in previous transfusion randomized control trials. RESULTS: Sixteen responses were collected of which 11 had previously participated in a transfusion randomized control trial. Various solutions were reported which were specific to the laboratory information system (LIS) and electronic medical record (EMR) combinations although solutions could be grouped into four categories which included the creation of a study product code in the LIS, preventing the transmission of data from the LIS to the EMR, utilizing specialized stickers and labels to conceal product containers and documents in the paper records, and modified bedside procedures and documentation. DISCUSSION: LIS and EMR combinations varied across sites, so it was not possible to determine combination-specific solutions. The study was able to highlight solutions that may be emphasized in future iterations of LIS and EMR software as well as procedural changes that may minimize the risk of unblinding.

Transfusion of ABO-group identical red blood cells following uncrossmatched transfusion does not lead to higher mortality in civilian trauma patients.

BACKGROUND: Questions persist about the safety of switching non-group O recipients of group O uncrossmatched red blood cells (RBC) or low titer group O whole blood (LTOWB) to ABO-identical RBCs during their resuscitation. METHODS: The database of an earlier nine-center study of transfusing incompatible plasma to trauma patients was reanalyzed. The patients were divided into three groups based on 24-h RBC transfusion: (1) group O patients who received group O RBC/LTOWB units (control group, n = 1203), (2) non-group O recipients who received only group O units (n = 646), (3) non-group O recipients who received at least one unit of group O and non-group O units (n = 562). Fixed marginal effect of receipt of non-O RBC units on 6- and 24-h and 30-day mortality was calculated. RESULTS: The non-O patients who received only group O RBCs received fewer RBC/LTOWB units and had slightly but significantly lower injury severity score compared to control group; non-group O patients who received both group O and non-O units received significantly more RBC/LTOWB units and had a slightly but significantly higher injury severity score compared to control group. In the multivariate analysis, the non-O patients who received only group O RBCs had significantly higher mortality at 6-h compared to the controls; the non-group O recipients of O and non-O RBCs did not demonstrate higher mortality. At 24-h and 30-days, there were no differences in survival between the groups. CONCLUSION: Providing non-group O RBCs to non-group O trauma patients who also received group O RBC units is not associated with higher mortality.

Transfusion of blood components containing ABO-incompatible plasma does not lead to higher mortality in civilian trauma patients.

BACKGROUND: This study investigated the effect on mortality of transfusing ABO-incompatible plasma from all sources during trauma resuscitation. METHODS: Demographic, transfusion, and survival data were retrospectively extracted on civilian trauma patients. Patients were divided by receipt of any quantity of ABO-incompatible plasma from any blood product (incompatible group) or receipt of solely ABO-compatible plasma (compatible group). The primary outcome was 30-day mortality, while other outcomes included 6- and 24-hour mortality. Mixed-effects logistic regression was used to model the effect of various predictor variables, including receipt of incompatible plasma, on mortality outcomes. RESULTS: Nine hospitals contributed data on a total of 2618 trauma patients. There were 1282 patients in the incompatible group and 1336 patients in the compatible group. In both the unadjusted and adjusted models, the 6-hour, 24-hour, and 30-day mortality rates were not significantly different between these groups. The patients in the incompatible group were then divided into high volume (>342 mL) and low volume (≤342 mL) incompatible plasma recipients. In the adjusted model, the high-volume group had higher 24-hour mortality when the Trauma Injury Severity Score survival prediction was >50%. Mortality at 6 hours and 30 days was not higher in this model. The low-volume group did not have increased mortality at any of the time points in this adjusted model. CONCLUSION: The transfusion of incompatible plasma in civilian trauma resuscitation does not lead to higher 30-day mortality. The finding of higher mortality in a select group of recipients in the secondary analysis warrants further study.

Nutritional (Fe, Mn, Ni, and Cr) and growth responses of rice plant affected by perennial application of two bio-solids.

Trace toxic elements often restrict the land application of different bio-solids in agriculture. In order to evaluate the separate influence of the municipal solid waste compost (MSW), sewage sludge (SS) and combined application with inorganic fertilizers (chemical fertilizer (CF)) on nutritional (Fe, Mn, Ni, and Cr) and growth responses of rice plant, a research was conducted on paddy soil from 2013 to 2015. Obtained results showed that SS levels were superior to MSW in most studied traits. The maximum chlorophyll content (46.52), plant height (162.6 cm), biomass (23.33 t ha-1), soil available Fe (206.26 ppm), Ni concentration in the root (14.41 ppm) and shoots (3.16 ppm), Cr concentration in the root (12.43 ppm) and grain (3.65 ppm), and Mn concentration in grain (66.938 ppm) belonged to SS levels, specially enriched 40 t ha-1, when it was added to the soil for three continuous years. The highest 1000-grain weight (29.89 g), yield (6.86 t ha-1), harvest index (48.17%), and soil available Mn (712.7 ppm), Fe, and Ni concentration in grain (107.92 and 8.79 ppm, respectively) were recorded in 3 years of applying the enriched 40 t ha-1 MSW. Accumulation of Ni in grain in critical levels and negative effects of CF treatments on toxic element entry to soil and plant were two important findings of this research that need management.

Continuous in vivo blood pressure measurements using a fully implantable wireless SAW sensor.

In this paper, the development of a fully implantable wireless sensor able to provide continuous real-time accurate pressure measurements is presented. Surface Acoustic Wave (SAW) technology was used to deposit resonators on crystalline quartz wafers; the wafers were then assembled to produce a pressure sensitive device. Excitation and reading via a miniature antenna attached to the pressure sensor enables continuous external interrogation. The main advantages of such a configuration are the long term stability of quartz and the low power necessary for the interrogation, which allows 24/7 interrogation by means of a hand-held, battery powered device. Such data are of vital importance to clinicians monitoring and treating the effects of hypertension and heart failure. A prototype was designed and tested using both a bio-phantom test rig and an animal model. The pressure traces for both compare very well with a commercially available catheter tip pressure transducer. The work presented in this paper is the first known wireless pressure data from the left ventricle of the heart of a living swine.

Vaccine-induced immune thrombotic thrombocytopenia and cerebral venous sinus thrombosis post COVID-19 vaccination; a systematic review.

INTRODUCTION: The common reported adverse effects of COVID-19 vaccination consist of the injection site's local reaction followed by several non-specific flu-like symptoms. However, rare cases of vaccine-induced immune thrombotic thrombocytopenia (VITT) and cerebral venous sinus thrombosis (CVST) after viral vector vaccines (ChAdOx1 nCoV-19 vaccine, Ad26.COV2 vaccine) have been reported. Herein we systemically reviewed the reported cases of CVST and VITT following the COVID-19 vaccination. METHODS: This systematic review was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. We searched PubMed until May 19, 2021, and the following Keywords were used: COVID Vaccine & Neurology, AstraZeneca COVID vaccine, ChAdOx1 nCoV-19 COVID vaccine, AZD1222 COVID vaccine, Janssen COVID vaccine, Johnson & Johnson COVID vaccine, Ad26.COV2 COVID vaccine. The authors evaluated the abstracts and titles of each article for screening and inclusion. English reports about post-vaccine CVST and VITT in humans were collected. RESULTS: Until May 19, we found 877 articles with the searched terms. We found 12 articles, which overall present clinical features of 36 patients with CVST and VITT after the ChAdOx1 nCoV-19 vaccine. Moreover, two articles were noted, which present 13 patients with CVST and VITT after Ad26.COV2 vaccine. The majority of the patients were females. Symptom onset occurred within one week after the first dose of vaccination (Range 4-19 days). Headache was the most common presenting symptom. Intracerebral hemorrhage (ICH) and/or Subarachnoid hemorrhage (SAH) were reported in 49% of the patients. The platelet count of the patients was between 5 and 127 cells×109/l, PF4 IgG Assay and d-Dimer were positive in the majority of the reported cases. Among 49 patients with CVST, at least 19 patients died (39%) due to complications of CVST and VITT. CONCLUSION: Health care providers should be familiar with the clinical presentations, pathophysiology, diagnostic criteria, and management consideration of this rare but severe and potentially fatal complication of the COVID-19 vaccination. Early diagnosis and quick initiation of the treatment may help to provide patients with a more favorable neurological outcome.

Comparison of cytologic giemsa and real-time polymerase chain reaction technique for the diagnosis of cutaneous leishmaniasis on scraping smears.

OBJECTIVE: To compare the results of real-time polymerase chain reaction (RT-PCR) for detection of Leishmania DNA in Giemsa-stained skin scraping slides with direct microscopic evaluation of Giemsa-stained skin scrapings and to estimate the sensitivity and specificity of RT-PCR. STUDY DESIGN: We used 30 samples from cases diagnosed with cutaneous leishmaniasis (CL), 16 from clinically suspected individuals but negative in direct microscopic evaluation and 50 normal individuals from nonendemic dry type CL areas. RESULTS: All samples of CL positive and 8 of suspected cases were positive for RT-PCR, and all nonleishmaniasis cases were negative. The sensitivity and specificity of RT-PCR were 100% (95% CI 88-100%) and 88% (95% CI 78-95%), respectively. We also found an inverse association between the number of lympnocytes (OR = 0.90, 95% CI 0.83-0.97%), neutrophils and Leishman bodies.

Wireless Interrogation of Implantable SAW Sensors.

Implantable sensors provide long-term, accurate physiological measurements after a minimally invasive procedure, particularly when designed as transponders. Wireless interrogation of deeply implanted transponders with RF remains a challenge due to the high loss at the skin-air interface and large tissue RF absorption. This paper presents a system for wirelessly interrogating surface acoustic wave (SAW) sensors implanted in the main pulmonary artery (PA), where the pressure (PAP) is a very important parameter in the management of heart failure patients. The proposed PAP monitoring system consists of an implantable SAW pressure sensor integrated with an antenna and anchor in a housing, an external antenna and an electronic interrogator. The PAP is determined by measuring the frequency of the echo signal from SAW sensor accurately. An asymmetric antenna was designed and integrated with the sensor. The combination of simulation, theoretical calculation and phantom measurement indicates that the path loss to the implant location, about 6 cm below the skin, is around 25 dB. A portable interrogator was designed based on a dual conversion receiver and single echo high frequency sampling approach to assess achievable frequency estimation accuracy predicted by Cramer-Rao Lower Bound (CRLB) analysis. The system was characterized using a high quality (Q) factor SAW sensor, fabricated at wafer level, wire-connected to the interrogator via an attenuator to simulate path loss. The signal-to-noise ratio (SNR) of captured echo signals was calculated and used in CRLB analysis. The analysis indicates that without using signal post processing, the sensor sensitivity has to be at least 440 Hz/mmHg in order to achieve a target 1 mmHg accuracy. Although the current sensor sensitivity is only 200 Hz/mmHg, the in vivo measurement showed that acceptable accuracy can be obtained by signal post processing. The results from an invasive catheter tip transducer measured simultaneously with the SAW sensor showed that the differences in pulse pressure and relative mean pressure are 0.8 mmHg and 1.4 mmHg, respectively. The accuracy could be further improved by increasing the sensor Q factor and sensitivity and reducing path loss.

High IKZF1/3 protein expression is a favorable prognostic factor for survival of relapsed/refractory multiple myeloma patients treated with lenalidomide.

The aim of this study is to assess nucleoprotein expression of IKZF1/3 in patients with relapsed/refractory multiple myeloma (MM) who received lenalidomide-based therapy and correlated them with their clinical outcomes. A total of 50 patients diagnosed with MM were entered in the study with the median follow-up of 86.4 months. By immunohistochemistry (IHC), IKZF1 and IKZF3 were expressed in 72 and 58% of the cases, respectively. IKZF1 and IKZF3 expressions were associated with longer median progression free survival (P = 0.0029 and P < 0.0001) and overall survival (P = 0.0014 and P < 0.0001). IKZF3 expression also appears predicted a favorable response to the lenalidomide-based therapy.

RF communication with implantable wireless device: effects of beating heart on performance of miniature antenna.

The frequency response of an implantable antenna is key to the performance of a wireless implantable sensor. If the antenna detunes significantly, there are substantial power losses resulting in loss of accuracy. One reason for detuning is because of a change in the surrounding environment of an antenna. The pulsating anatomy of the human heart constitutes such a changing environment, so detuning is expected but this has not been quantified dynamically before. Four miniature implantable antennas are presented (two different geometries) along with which are placed within the heart of living swine the dynamic reflection coefficients. These antennas are designed to operate in the short range devices frequency band (863-870 MHz) and are compatible with a deeply implanted cardiovascular pressure sensor. The measurements recorded over 27 seconds capture the effects of the beating heart on the frequency tuning of the implantable antennas. When looked at in the time domain, these effects are clearly physiological and a combination of numerical study and posthumous autopsy proves this to be the case, while retrospective simulation confirms this hypothesis. The impact of pulsating anatomy on antenna design and the need for wideband implantable antennas is highlighted.

Genomic aberrations in anaplastic multiple myeloma: high frequency of 1q21(CKS1B) amplifications.

Anaplastic multiple myeloma (AMM) is a rare morphologic variant of MM with adverse prognosis. The underlying molecular cytogenetic abnormalities are poorly understood. We investigated 11 patients with AMM for myeloma associated cytogenetic aberrations and compared with 188 non-anaplastic MM using fluorescent in situ hybridization. Of the 11 AMM patients studied, 10 had CKS1B amplification, 5 hemizygous 17p(p53) deletions, 4 13q14 deletions, 4 t(4:14), and 2 had t(11:14). AMM was associated with significantly higher prevalence of CKS1B amplification (91% vs. 34%, p<0.001), 17p(p53) deletion (45% vs. 11%, p=0.006) and t(4,14) (36% vs. 14%, p=0.015) than non-anaplastic MM, which may have resulted in the genetic instability and more aggressive clinical course.

Mixed medullary-follicular carcinoma of the thyroid.

Introduction. Mixed medullary-follicular thyroid carcinoma is an uncommon tumor that consists of both follicular and parafollicular cells. Case. We report a 43-year-old woman with a palpable mass in the right side of the neck. Fine needle aspiration suggested a diagnosis of high grade anaplastic carcinoma that has been associated with papillary features. Total thyroidectomy was done in which histopathological examination showed diagnosis of medullary carcinoma. Immunohistochemical staining was positive for chromogranin, calcitonin, and thyroglobulin in tumoral cells. Conclusion. Mixed medullary-follicular thyroid carcinoma is a rare tumor. Diagnosis of these tumors with fine needle aspiration is very difficult and may lead to misdiagnosis. It is necessary to correlate the cytological finding with serum calcitonin and thyroglobulin. Also immunostaining for calcitonin and thyroglobulin confirms diagnosis.

Effect of soil and physiographic factors on ecological plant groups in the eastern Elborz mountain rangeland of Iran.

To investigate the cause of differences among ecological plant groups in the east of the Elborz mountain rangeland, the role of edaphical and topographical characteristics was considered. Two ordination techniques, detrended correspondence analysis (DCA) and canonical correspondence analysis (CCA), were used. The values of slope, aspect, altitude and lithology information were provided by Geographic Information System (GIS), and geomorphological land units were determined by intersection of overlaid data layers. Plant sampling was undertaken within nine land units with similar lithology and altitude but which differed in slope and aspect, using 30 randomly selected 1 m2 plots per land unit. Soil samples were taken from two depths (0-20 and 20-50 cm) in each plot. Organic matter, bulk density, texture, calcium carbonate, total nitrogen and available phosphorus and potassium contents were determined. The results indicated that plant species have different responses to edaphical and topographical parameters. The invader species group had a balanced amount of influence from all soil components and topographic factors, whereas the native grasses were located in productive soils, which typically have a low grazing intensity, such as the north facing slopes. Coniferous bushy trees, cushion plants and some shrub plant groups were found on steep slopes with alkaline soils. The broad-leaved bushy trees plant group was abundant in fine texture soils on low and humid slopes.

The use of principal component analysis in studying physical, chemical and biological soil properties in southern caspian forests (North of Iran).

This research was conducted in Khanikan forests located in lowland of Mazandaran province (North of Iran). Eighteen profiles were dug and several chemical, physical and biological soil properties were investigated. The soil properties evaluated were soil pH, bulk density, saturation moisture content, electrical conductivity, organic carbon, total nitrogen, cation exchangeable capacity, available phosphorous, soil texture, calcium carbonate content, number and biomass of earthworms, litter carbon and litter nitrogen. Principal Component Analysis (PCA) was used to identify the variation of soil properties. PCA, a technique which reduces the dimensionality of multivariate data by removing Interco relations among variables, has a number of useful applications in forest researches. The results showed significant relationships between some soil factors with PC1 and PC2 axes, also, among different soil factors, the distribution of forest types was most strongly controlled with some soil characteristics such as acidity, bulk density, texture, phosphorous, organic carbon, total nitrogen and cation exchangeable capacity.

Leaf and seed micronutrient accumulation in soybean cultivars in response to integrated organic and chemical fertilizers application.

Plant nutrients can be influenced by organic materials of soils. An experiment was conducted to evaluate the effect of organic amendments on elements uptake by soybean cultivars in a silty loam soil in Mazandaran province, Iran. The experiment was carried out in split plot based on randomized complete block design with three replications in 2006. Main plots were included 8 fertilizer treatments consisted of 20 and 40 Mg ha(-1) Municipal Solid Waste Compost (MSW), Vermicompost (VC) and Sewage Sludge (SS) which enriched with 50% chemical fertilizers needed by soil, only chemical fertilizer treatment and control. Sub plots consisted of three genotypes of soybean (032, 033 and JK). Grain yield was determined and soybean leaves and seeds were digested and analyzed for Mn, Cu, Zn and Fe. Results showed that yield and elements content in soybean leaves and seeds (Mn, Cu, Zn and Fe) were influenced by all treatments. The 40 Mg ha(-1) of sewage sludge enriched with chemical fertilizers produced maximum grain yield. Different soybean cultivars had also significant differences in terms of leaf and seed micronutrients accumulation. Maximum grain yield was observed in JK and 033. Mean comparisons showed that interaction effects of fertilizer and cultivar had significant differences on Mn, Cu and Fe content in soybean leaves, so that the maximum Cu content was observed in 032 cultivars with 40 Mg ha(-1) enriched sewage sludge and municipal waste compost. Also the highest amount of Fe was obtained for JK cultivar when the 40 Mg ha(-1) of municipal compost was used. Among different mentioned traits, Fe and Cu content in leaf and seed and Zn content in leaf had a positive and significant correlation with grain yield.