Common Clinical Tests Research Articles

A systematic review on prevalence, risk factors, clinical diagnosis and medical management of dry eye disease in the Arab population

Background: Dry eye (DE) is a multifactorial disorder that can influence tear production, functional visual acuity and ultimately increase the osmolarity of the tear film. The prevalence of DE ranges from 7% to 33% across the world. However, to the best of our knowledge, the prevalence range of DE in Arab countries is not precisely documented in the literature. Aim: The aim of this article was to determine the prevalence range of DE, investigate the major risk factors of DE and identify the clinical diagnosis and medical management of DE. Method: In this study, only English language articles from 2017 to 2020 were selected. There were 52 articles on prevalence, risk factors, clinical diagnosis and medical management of DE in the Arab population. Results: The prevalence of DE in the Arab population varies in reports, from 10% in the United Arab Emirates (Dubai) to 69% in Palestine (West Bank). Gender difference (DE more in women), wearing of contact lenses, diabetes mellitus and glaucoma were all known to intensify the symptoms of DE. Lastly, there are two approaches to reduce DE in the Arab population, namely, pharmacologic and non-pharmacologic methods. Conclusion: The prevalence of DE in the Arab population was relatively high. In addition, the ocular surface disease index is one of the most common tools for the diagnosis of DE, whilst tear break-up time test is the common clinical test used in the Arab reports. Lastly, the most common treatment for DE is artificial tears.

An Overview of Characteristics of Clinical Next-Generation Sequencing–Based Testing for Hematologic Malignancies

With the increasing integration of molecular alterations into the evaluation of hematologic malignancies (HM), somatic mutation profiling by next-generation sequencing (NGS) has become a common clinical testing strategy. Limited data are available about the characteristics of these assays. To describe assay characteristics, specimen requirements, and reporting practices for NGS-based HM testing using College of American Pathologists proficiency testing survey data. The College of American Pathologists NGS Hematologic Malignancies Survey (NGSHM) results from 78 laboratories were used to determine laboratory practices in NGS-based HM testing. The majority of laboratories performed tumor-only (88.5% [69 of 78]), targeted sequencing of cancer genes or mutation hotspots (98.7% [77 of 78]); greater than 90% performed testing on fresh bone marrow and peripheral blood. The majority of laboratories reported a 5% lower limit of detection for single-nucleotide variants (73.1% [57 of 78]) and small insertions and deletions (50.6% [39 of 77]). A majority of laboratories used benchtop sequencers and custom enrichment approaches. This manuscript summarizes the characteristics of clinical NGS-based testing for the detection of somatic variants in HM. These data may be broadly useful to inform laboratory practice and quality management systems, regulation, and oversight of NGS testing, and precision medicine efforts using a data-driven approach.

Pediatric Acute Appendicitis Score in Children With Acute Abdominal Pain (AAP).

The aim of the study was to compare the accuracy of common clinical findings, laboratory tests and diagnostic score (DS) in diagnosis of clinically confirmed acute appendicitis (AA) in children. A cohort of 188 children under the age of 15 years presenting with acute abdominal pain (AAP) were included in the study. The clinical history (n=21), signs (n=14) and tests (n=3) were recorded in each child. The significant independent diagnostic predictors (disclosed by multivariate logistic regression model) were used to construct the DS formulas for AA diagnosis. These formulas were tested at six different cut-off levels to establish the most optimal diagnostic performance for clinically confirmed AA. In the receiver operating characteristic curve (ROC) comparison test, there was a statistically significant difference (p=0.0055) in the area under curve (AUC) values between i) clinical history and symptoms (AUC=0.594), and ii) signs and laboratory tests (AUC=0.734), whereas both were significantly inferior (p=0.0001) to the AUC value of the DS (AUC=0.952). In diagnosis of clinically confirmed AA in children, the DS formula is superior to both the clinical history/symptoms and signs/lab tests, justifying the use of DS as an integral part of the diagnostic algorithm of AA in all children presenting with AAP.

Clinical tests used to diagnose anterior cruciate ligament tears are less sensitive in obese patients: a retrospective cohort study

Background: Anterior cruciate ligament (ACL) rupture is a common athletic injury. Multiple clinical studies have evaluated the sensitivity and specificity of physical examination tests that are used to diagnose ACL injury. We sought to determine if the sensitivity of these clinical tests is affected by a patient’s body habitus. We hypothesized that sensitivity of the Lachman, anterior drawer, and pivot shift tests is lower in obese patients than in patients with a normal body mass index (BMI). Methods: We compared the sensitivity of three clinical tests, the Lachman, anterior drawer, and pivot shift, in a group of obese patients with a group of nonobese patients. A total of 181 adult patients who had undergone ACL reconstruction by a single surgeon were included in the study. Results: Sensitivity of the Lachman test was 87.3% in obese patients versus 94.1% in the nonobese control group. Sensitivity of the anterior drawer test was 76.3% in obese patients compared to 88.2% in the nonobese control group. Sensitivity of the pivot shift test could not be accurately assessed because pain and swelling prevented the physician from performing this test in most patients on their initial presentation. Conclusions: The sensitivity of common clinical tests used to diagnose ACL tear, the Lachman, anterior drawer, and pivot shift, is decreased in obese patients compared with the nonobese control group. This study suggests that a clinician may need to have a lower threshold to perform advanced imaging in an obese patient with a suspected ligamentous injury of the knee even if the physical examination is not fully indicative of ligamentous injury. Level of Evidence: Level III.

Performance of a Diagnostic Score in Confirming Acute Cholecystitis Among Patients With Acute Abdominal Pain.

Although acute cholecystitis (AC) is quite a frequent clinical cause of acute abdominal pain (AAP), the accuracy of a diagnostic score (DS) in confirming AC is rarely considered. The aim of the study was to conduct a detailed analysis comparing the accuracy of common clinical findings, laboratory tests and DS in AC diagnosis. A cohort of 1,333 patients presenting with AAP were included in the study. The clinical history and diagnostic symptoms (n= 21), signs (n=14) and laboratory tests (n=3) were recorded in each patient. The significant independent diagnostic predictors (disclosed by multivariate logistic regression model) were used to construct the DS formulas for AC diagnosis. These formulas were tested at five different cut-off levels to establish the most optimal diagnostic performance for clinically confirmed AC. In the ROC comparison test, there was no statistically significant difference in the AUC values of i) clinical history and symptoms (AUC=0.542), and ii) signs & laboratory tests (AUC=0.580), whereas both were significantly inferior (p=0.0001) to the AUC value of the DS (AUC=0.962). In the diagnosis of clinically confirmed AC, the DS formula is superior to clinical symptoms and signs, justifying the use of DS as an integral part of the diagnostic algorithm of AC in all patients presenting with AAP.

Evaluation of different airway tests to determine difficult intubation in apparently normal adult patients undergoing surgical procedures

BackgroundInadequate maintenance of a patient’s airway represents a major cause of anesthesia-related morbidity and mortality. This study was designed to evaluate common preoperative clinical tests to determine the risk of difficult endotracheal intubation in apparent “normal” adult patients undergoing surgical procedures.MethodsA prospective observational cohort study was performed on 160 consecutive adult patients undergoing surgical procedures at an academic medical center in Jordan from 20 May 2019 until 11 February 2020.Preoperative assessment of airway risk stratification was performed by the following clinical tests: the mandible protrusion test (MPT), thyromental (TMD) and sternomental (SMD) distances, inter-incisor gap (IIG), and the modified Mallampati tests with tongue protrusion (MMT-TP) and without tongue protrusion (MMT-NTP). Grade C on the MPT, TMD ≤ 6 cm, SMD ≤ 12 cm, and MMT grades III and IV were considered to be predictors of difficult endotracheal intubations. A modified Cormack-Lehane grading (MCLG) of laryngoscopic views with backward, upward, and right-sided pressure on the thyroid and cricoid cartilages (BURP) maneuver was also documented, with grades 2B, 3, and 4 considered to be difficult airways for intubation.ResultsFifteen patients (9.4%) were classified as MCLG 2B, 3, and 4, with age significantly associated with the MCLG grade (P = 0.028). The sensitivity and Youden’s index of MMT-TP were found to be the lowest (40% and 0.29, respectively). The MPT was the most accurate and specific test (90.63 and 95.17%, respectively), with the highest PPV (50%), Youden’s index (0.42), and area under the curve (AUC) (0.781). Bivariant analysis of MPT and the t-test of the mean TMDs and SMDs revealed significant associations between these airway tests and the difficulty of intubation (P values: < 0.001, 0.02, < 0.01, respectively).ConclusionThe MPT, with its highest accuracy, specificity, positive predictive value, and good sensitivity may be used as a routine screening test for preoperative prediction of difficult endotracheal intubations.

3085 – THE EPOR STIMULATES RAPID CYCLING AND FORMATION OF LARGER RED CELLS DURING MOUSE AND HUMAN ERYTHROPOIESIS

EpoR signaling is essential for the survival of erythroid precursors during terminal differentiation, when these cells undergo 3-5 cell divisions that are coupled to a rapid loss in cell size. The absolute dependence of erythroblasts on EpoR signaling for survival makes it challenging to identify other essential functions of EpoR in these cells. Key open questions include a role for EpoR in cell cycle regulation; and a potential role for EpoR in the induction of erythroid genes. To address these gaps, we developed a genetic system that allowed us to examine essential non-survival functions of EpoR signaling in erythroid differentiation. We rescued mouse Epor-/- fetal liver erythroid progenitors from apoptosis by transduction with the anti-apoptotic protein bcl-xL, comparing their ensuing differentiation with that of Epor-/- progenitors that were rescued by re-introduction of the EpoR. We found that the bcl-xL survival signal, in the absence of any EpoR signaling, was sufficient to allow erythroid terminal differentiation and formation of anucleated red cells. However, key features were abnormal. First, erythroblasts underwent slower and fewer cell cycles, generating fewer than half the number of red cells, showing an essential role for EpoR signaling in the regulation of cell cycle speed and number. Second, we found that EpoR signaling unexpectedly increased red cell size, in spite of the concurrent increase in the number of cell divisions. Using mice doubly deleted for both EpoR and HRI, we found that EpoR regulation of red cell size is independent of the well-described red cell size regulation by iron and heme. Healthy human volunteers that were administered Epo showed an increase in mean corpuscular volume (MCV) that persisted long after Epo and reticulocyte levels returned to baseline, supporting a role for the regulation of red cell size by Epo and suggesting new diagnostic interpretations for this common clinical test. Together, our findings reveal novel functions for the EpoR in erythroid differentiation including an unexpected role in the regulation of red cell size.

A toxicogenomic approach to assess kidney injury induced by mercuric chloride in rats

Kidney injury caused by disease, trauma, environmental exposures, or drugs may result in decreased renal function, chronic kidney disease, or acute kidney failure. Diagnosis of kidney injury using serum creatinine levels, a common clinical test, only identifies renal dysfunction after the kidneys have undergone severe damage. Other indicators sensitive to kidney injury, such as the level of urine kidney injury molecule-1 (KIM-1), lack the ability to differentiate between injury phenotypes. To address early detection as well as detailed categorization of kidney-injury phenotypes in preclinical animal or cellular studies, we previously identified eight sets (modules) of co-expressed genes uniquely associated with kidney histopathology. Here, we used mercuric chloride (HgCl2)―a model nephrotoxicant―to chemically induce kidney injuries as monitored by KIM-1 levels in Sprague Dawley rats at two doses (0.25 or 0.50 mg/kg) and two exposure lengths (10 or 34 h). We collected whole transcriptome RNA-seq data derived from five animals at each dose and time point to perform a toxicogenomics analysis. Consistent with documented injury phenotypes for HgCl2 toxicity, our kidney-injury-module approach identified the onset of necrosis and dilation as early as 10 h after a dose of 0.50 mg/kg that produced only mild injury as judged by urinary KIM-1 excretion. The results of these animal studies highlight the potential of the kidney-injury-module approach to provide a sensitive and histopathology-specific readout of renal toxicity.

A comparative analysis of unintegrated HIV-1 DNA measurement as a potential biomarker of the cellular reservoir in the blood of patients controlling and non-controlling viral replication

BackgroundThe persistence of HIV-1 in reservoir cells is one of the major obstacles to eradicating the virus in infected individuals receiving combination antiretroviral therapy (ART). HIV-1 persists in infected cells as a stable integrated genome and more labile unintegrated DNA (uDNA), which includes linear, 1-LTR and 2-LTR circular DNA. 2-LTR circle DNA, although less abundant, is considered a surrogate marker of recent infection events and is currently used instead of the other unintegrated species as a diagnostic tool. This pilot study aimed to investigate how to best achieve the measurement of uDNA.MethodsA comparative analysis of two qPCR-based methods (U-assay and 2-LTR assay) was performed on the blood of 12 ART-naïve, 14 viremic and 29 aviremic On-ART patients and 20 untreated spontaneous controllers (HIC), sampled at a single time point.ResultsThe U-assay, which quantified all unintegrated DNA species, showed greater sensitivity than the 2-LTR assay (up to 75%, p < 0.0001), especially in viremic subjects, in whom other forms, in addition to 2-LTR circles, may also accumulate due to active viral replication. Indeed, in aviremic On-ART samples, the U-assay unexpectedly measured uDNA in a higher proportion of samples (76%, 22/29) than the 2-LTR assay (41%, 12/29), (p = 0.0164). A trend towards lower uDNA levels was observed in aviremic vs viremic On-ART patients, reaching significance when we combined aviremic On-ART and HIC (controllers) vs Off-ART and viremic On-ART subjects (non-controllers) (p = 0.0003), whereas 2-LTR circle levels remained constant (p ≥ 0.2174). These data were supported by the high correlation found between uDNA and total DNA (r = 0.69, p < 0.001).ConclusionsThe great advantage of the U-assay is that, unlike the 2-LTR assay, it allows the accurate evaluation of the totality of uDNA that can still be measured even during successful ART when plasma viremia is below the cut-off of common clinical tests (< 50 copies/mL) and 2-LTR circles are more likely to be under the quantification limit. UDNA measurement in blood cells may be used as a biomarker to reveal a so far hidden or underestimated viral reservoir. The potential clinical relevance of uDNA quantification may lead to improvements in diagnostic methods to support clinical strategies.

Https://ijmrr.medresearch.in/index.php/ijmrr/issue/view/61

Objectives: Aim of this study is to evaluate the types and incidence of injuries in internal derangement of the knee joint by MRI and to compare with arthroscopy findings in selected cases and to assess whether MRI can be used as a primary diagnostic tool for internal derangement of the knee joint. Material and Method: This prospective study was done in the Department of Radiodiagnosis Chirayu Medical College and Hospital Bhopal, Madhya Pradesh, India. A total of 100 patients who were referred to the department with strong clinical suspicion of internal derangements of knee joint, underwent magnetic resonance imaging evaluation of knee followed by arthroscopy in selected cases, wherever indicated from August 2014 to July 2019. Results: Majority of patients in the current study group belonged to the age group 20-29 years (31%) with a mean age of 24.3 years. In this study, the majority of patients were males constituting 76 % of cases. The most common clinical presentation was that of pain in knee joint seen in 79% of cases. The second most common presentation was swelling seen in 54%. The most common positive clinical test was McMurray’s test for meniscal tear seen positive in 48% of cases. In the current study left knee involvement was more common than right knee, constituting 54%. Medial meniscal tears were more common than lateral meniscal tears 49 (73.2%). Conclusion: MRI is a useful non-invasive modality having high sensitivity, specificity and accuracy in the diagnosis of meniscal and cruciate ligament injuries. MRI should be done in every patient of suspected internal derangement of the knee joint, to save a patient from unnecessary arthroscopy

Knee joint kinematics of the pendulum test in children with and without Down syndrome

BackgroundThe Wartenberg pendulum test is a common clinical test that is used to measure stiffness about the knee in persons with and without disabilities such as cerebral palsy and Down syndrome (DS). Adults and adolescents with DS show fewer number of swing cycles and a lower relaxation index than healthy controls. However, it is not clear if children with DS show a similar trend compared to typically developing (TD) children. Research questionWas the knee joint kinematics different between children with and without DS during the pendulum test? MethodsThirteen children with DS and 13 TD children participated in this study. There were two load conditions: no load (NL) and with ankle load (AL) equal to 2 % of the subject’s body weight. Five trials of a pendulum test were collected for each condition. ResultsThe DS group showed a smaller first flexion excursion, a lower relaxation index, lower mean and peak velocities and accelerations during the first and second flexion and extension, and greater variability of acceleration during the first flexion than the TD group across both load conditions. This suggests that the DS group may have greater stiffness of the knee than the TD group to compensate for joint instability. SignificanceThe pendulum test appears to be a valid test to evaluate the passive stiffness of the knee in children with DS. The lower relaxation index in children with DS suggests that larger bursts of quadriceps may be activated during a pendulum test, particularly in the first flexion excursion, to assure the knee joint stability.

Single-cell modeling of routine clinical blood tests reveals transient dynamics of human response to blood loss

Low blood count is a fundamental disease state and is often an early sign of illnesses including infection, cancer, and malnutrition, but our understanding of the homeostatic response to blood loss is limited, in part by coarse interpretation of blood measurements. Many common clinical blood tests actually include thousands of single-cell measurements. We present an approach for modeling the unsteady-state population dynamics of the human response to controlled blood loss using these clinical measurements of single-red blood cell (RBC) volume and hemoglobin. We find that the response entails (1) increased production of new RBCs earlier than is currently detectable clinically and (2) a previously unrecognized decreased RBC turnover. Both component responses offset the loss of blood. The model provides a personalized dimensionless ratio that quantifies the balance between increased production and delayed clearance for each individual and may enable earlier detection of both blood loss and the response it elicits.

Simple Spline Representation for Identifying Sit-to-Stand Strategies.

Standing from a seated position is an activity of daily living and a common clinical test of strength and balance. While this action is well-studied biomechanically, there remains a need for a clear modelling method for appropriately capturing performance and discriminating between standing strategies. This paper presents a simple framework for representing the rise from a chair as a set of splines. This formulation is inherently differentiable, defines a clear start and end point of the motion, and allows for secondary analysis of dynamic and energetic effects. This method is tested on two healthy subjects performing four different standing strategies. The spline method was found to accurately capture the standing action, with mean absolute errors of 1-2 cm for joint position, and 2-3 degrees angular error across the different standing strategies. Analysis of the spline trajectories revealed strategy-specific differences in kinematic, kinetic, and dynamic bio-markers. This suggests that low order splines can be used to accurately capture variations in sit-to-stand actions.

EVALUATING THE RELATIONSHIP BETWEEN CLINICAL ASSESSMENTS OF APPARENT HAMSTRING TIGHTNESS: A CORRELATIONAL ANALYSIS

Hamstring tightness is a common condition typically assessed via the active knee extension (AKE), passive straight leg raise (PSLR), V-sit and reach (VSR), and finger-floor-distance (FFD). The purpose of this study was to investigate the relationships between four common clinical tests of apparent hamstring tightness. A secondary purpose was to compare the differences in correlations between sub-groups based on positive test findings. Descriptive, correlational laboratory design. Recreationally active individuals (N = 81; 23.7 ± 5.9 years) performed the AKE, PSLR, VSR, and FFD in a randomized order, and subsequent correlational analyses were conducted. Strong correlations were identified between the VSR and FFD (r = -.798, r2 = .637, p < .001); moderate correlations were demonstrated between the PSLR and FFD (r = -.565, r2 = .319, p < .001) and PSLR and VSR (r = .536, r2 = .287, p < .001). Low correlations were found between the PSLR and AKE (r = -.284, r2 = .081, p = 0.01), AKE and VSR (r = -.297, r2 = .088, p = .007), and AKE and FFD (r = .263, r2 = .069, p = .018). If one assessment was identified in a subject as dysfunctional, all relationships were affected, regardless of which assessment was dysfunctional. The AKE, one of the most common measures for apparent hamstring tightness, has low correlations with the other assessments. Based on the findings of this study, it is possible that not all assessments of AHT are measuring the same phenomena, with each involving different factors of perceived hamstring length. Level 2b.

Level of Actual Physical Fitness and its Perception among Students of Physiotherapy in Lahore

OBJECTIVE: To assess estimated and measured the physical fitness level of physiotherapy students.METHODOLOGY: This Cross sectional study carried out at Azra Naheed Medical College and School of Allied Health Sciences, Children Hospital Lahore, with Simple convenient sampling technique. The data was collected from 115 students including 42 male and 73 female, from 3rd year to final year. Self-perceived fitness questionnaire was used for estimation of perceived fitness and actual physical fitness level was measured by common clinical tests. Harvard step was used for fitness index measurement. SPSS version 21.0 was used for analysis and Pearson correlation for the correlation of perceived and measured physical fitness level. RESULTS: It was evident that physiotherapy students have good perception about their BMI. Results of perceived and measured body composition were correlated significantly .004 because they have good perception of body composition. Measured strength was low from the perceived, although some maleswere in average level. The results of strength show significant correlation for upper extremity that was 269 but for lower extremity non-significant. But measured flexibility results were good for lower extremities as compared to the shoulder flexibility for upper extremities, but both variables were differentfrom perceived fitness. Actual fitness index level was very low as compared to the self-estimated. CONCLUSION: Measured fitness was quite different from self-perceived. The students of physiotherapy were not physically fit as they perceived it. They need to improve their physical fitness level as their profession requires.

Use of Metatarsophalangeal Joint Dorsal Subluxation in the Diagnosis of Plantar Plate Rupture

A dorsal drawer exam, also known as a modified Lachman's test, is a common clinical test for plantar plate insufficiency. This disorder presents as a dislocated metatarsophalangeal joint. The aim of this cadaveric case study was to quantify the degree of the plantar plate pathology necessary to correlate with a positive Lachman's test. The second metatarsophalangeal joint was tested on 18 cadaveric lower extremities. Limbs with previous digital surgery or with an obvious digital deformity were excluded from this study. A plantar linear incision over the plantar aspect of the second metatarsophalangeal joint was performed, and the flexor tendons were retracted to expose the plantar plate. After evaluating the plantar plate's integrity and measuring its width, a Lachman's test was then performed under fluoroscopy. The plantar plate was subsequently severed in a serial manner in 2-mm increments. A modified Lachman's test was performed with the different levels of rupture to assess the degree of dislocation. We found that a tear as small as 2 mm, detected in 12 (66.7%) of 18 specimens, produced gross instability in the second metatarsophalangeal joint. We also showed that a simulated plantar plate tear ≥4 mm but <6 mm resulted in joint subluxation (positive modified Lachman's test) with a sensitivity of 90.3%. This study reinforces the finding that a modified Lachman's test is a clinical exam that demonstrates high sensitivity in diagnosing plantar plate insufficiency.

Does Altering Sitting Posture Have a Direct Effect on Clinical Shoulder Tests in Individuals With Shoulder Pain and Rotator Cuff Degenerative Tears?

Posture variations have been repeatedly linked to shoulder kinematics, strength, range of motion, and rotator cuff diseases. However, to our knowledge, no study has yet examined their possible link with shoulder pain provocation and pain levels during clinical shoulder tests. The objective was to examine whether changing posture while sitting modifies pain provocation and pain level during performance of 3 clinical shoulder tests in participants with shoulder pain and rotator cuff degenerative tears (RCDTs). Seventy individuals were allocated into 2 groups by an experienced physical therapist: 35 participants with symptomatic shoulders and RCDT diagnosed by ultrasound (tear size = 1.0 +/- 0.5 cm) and 35 control participants with no symptoms in the upper limb. All participants were tested by a second physical therapist for pain provocation (yes/no) and pain level (visual analog scale) using 3 common clinical shoulder tests: the Neer, the Hawkins-Kennedy, and the empty can while sitting in a neutral, slouched, and upright posture. Shoulder muscle forces were examined by a hand-held dynamometer for possible correlations only in the neutral posture. All participants were asked to fill out the quick DASH (disabilities of the arm shoulder and hand) questionnaire. In the symptomatic group, all 3 clinical tests demonstrated similar pain provocation (100% repeatability) and pain level in all 3 sitting postures (visual analog scale scores 3.7-4.4). Muscle force mean ranges of the study groups were 4.4 to 7 kg and, in the control group, 6 to 10.5 kg. No correlations were found between age, body mass index, shoulder pain, hand dominance, onset of symptoms, severity, and tear size with any of the dependent variables. Changing posture while sitting did not directly affect pain provocation and pain levels during performance of 3 clinical shoulder tests in participants with shoulder pain and RCDTs.

A Prospective, Single-Blind, Randomized, Phase III Study to Evaluate the Safety and Efficacy of Fibrin Sealant Grifols as an Adjunct to Hemostasis During Soft Tissue Open Surgery

Background/Purpose: Rapid hemostasis, an essential prerequisite of good surgical practice during surgical bleeding, including soft tissue open surgery, often requires adjunctive treatment. We evaluated the safety and hemostatic effectiveness of a human plasma-derived fibrin sealant (FS Grifols) in soft tissue open surgery. Methods: Patients with moderate soft tissue bleeding during open, urologic, gynecologic or general surgery were studied. The trial consisted of a preliminary phase (to familiarize investigators with the technique for FS Grifols application and the intraoperative procedures required by the clinical protocol) and a primary phase: in both phases, patients were randomized 1:1 to FS Grifols or Surgicel®. The primary efficacy endpoint, based on analysis of subjects in the primary phase of the study, was to evaluate whether FS Grifols was non-inferior to Surgicel® in achieving hemostasis, based on the proportion of subjects in both treatment groups who achieved hemostasis at the target bleeding site (TBS) by 4 min (T4) following the start of treatment application. Safety assessments included adverse events (AEs), vital signs, physical assessments, common clinical laboratory tests, viral markers, and immunogenicity. Results: A total of 224 subjects were randomized (primary phase): FS Grifols (N = 116), Surgicel® (N = 108). The 95% CI at T4 for the ratio of the proportion of patients achieving hemostasis in the two treatment groups was 1.064 (0.934, 1.213), indicating non-inferiority for FS Grifols vs. Surgicel®. The rate of hemostasis at the TBS by T4 in both phases of the study was higher in the FS Grifols treatment group (preliminary phase: 90.2%; primary phase: 82.8%) than in the Surgicel® treatment group (preliminary phase: 78.8%; primary phase: 77.8%). Overall, reported AEs were as expected in surgical patients and were similar between the two treatment groups. Conclusions: This study shows the non-inferiority in time to hemostasis of FS Grifols vs. Surgicel as an adjunct to hemostasis in patients undergoing soft tissue open surgery, and a similar rate of AEs.

Скрининговый тест выявления тромбоза глубоких вен и тромбоэмболии легочной артерии

Введение. Учитывая распространенность тромбозов, а каждый год в большинстве стран тромбоз глубоких вен (ТВГ) или тромбоэмболия легочной артерии (ТЭЛА) развивается у 80–120 человек на 100 тысяч населения, актуальным является использование скрининговых параметров гемостаза и оценка предрасположенности к тромбозам. Важным лабораторным маркером тромбоза и тромбоэмболии является Д-димер. Представляет интерес сравнение тестов различной чувствительности, имеющих признанное клиническое применение, для принятия решения о возможности их использования в ходе амбулаторного скрининга пациентов. Материалы и методы. Исследованы цитратные пробы крови 101 пациента (средний возраст — 41 ± 9,1 лет), среди которых были сформированы 3 группы: 69 человек, проходивших диспансерное обследование; 8 пациентов отделения интенсивной терапии; 24 пациента с подтвержденным сердечно-сосудистым заболеванием. Исследование содержания Д-димера в пробах цитратной плазмы выполняли одномоментно 2 методами: иммунотурбодиметрическим (ИТД) и иммунохемилюминесцентным (ИХЛ). Результаты. Получены результаты сравнения 2 методов исследования Д-димера. Коэффициент корреляции в разных группах пациентов составил 0,74–0,99 в зависимости от патологии, что свидетельствует о высокой степени соответствия результатов измерения Д-димера и возможности применения как метода ИТД, так и метода ИХЛ в скрининге пациентов с целью исключения ТВГ и ТЭЛА. Заключение. Проведенные исследования позволяют рассматривать метод ИХЛ для исследования содержания Д-димера на анализаторе Immulite 2000 XPi как скрининговый для амбулаторного догоспитального обследования пациентов. Introduction. Every year in most countries deep vein thrombosis (DVT) or pulmonary embolism (PE) develops in 80–120 people per 100 thousand population so screening of hemostatic parameters and assessment of predisposition to thrombosis is very actual problem. D-dimer is the important laboratory marker of thrombosis and thromboembolism. It is of interest to compare common clinical tests with diff erent sensitivities to determine whether they can be used during outpatient screening. Materials and methods. We examined citrate blood samples of 101 patients (mean age — 41 ± 9.1 years) who were divided into 3 groups: 69 persons passed the outpatient examination; 8 patients were in intensive care unit; 24 patients had confirmed cardiovascular disease. Measurement of D-dimer content in citrate plasma samples was carried out simultaneously by 2 methods: immunoturbodimetry (ITD) and immunochemiluminescence (IСL). Results. We obtained the results of D-dimer levels that were measured by 2 methods and calculated their relationships. The correlation coeffi cient in diff erent patient groups was 0.74–0.99 depending on their pathology. This fact shows a high degree of compliance of D-dimer results and the possibility of using both methods (ITD and IСL) in screening patients for excluding DVT and PE. Conclusion. Our researches allow to consider the IСL method for studying D-dimer content by Immulite 2000 XPi analyzer as a screening method for outpatient pre-hospital examination.

An exploration of the use of Inertial Measurement Units in the assessment of dynamic postural control of the knee and the effect of bracing and taping

© 2018 IOS Press and the authors. BACKGROUND: The Star Excursion Balance Test (SEBT) is a common clinical test that can provide information about dynamic movement, but does not reflect movement quality or postural-control strategies, and does not report kinematics of the lower limb. PURPOSE: To assess the dynamic postural control of healthy subjects using inertial measurement units (IMUs) and clinical SEBT scores to determine the effect of knee bracing and taping. METHODS: Twenty-four healthy individuals performed the SEBT under three randomised conditions (patellar bracing, patellar taping, and control condition (no intervention). Clinical SEBT scores were recorded and normalised to leg length and angular velocities were measured using IMUs during SEBT. Composite scores were calculated as the sum of clinical scores in each direction divided by three. Descriptive statistics (mean±sd) were calculated for each variable and repeated measures ANOVA were used to identify differences between limb (dominant, non-dominant) and condition. MAIN RESULTS: Compared to the control condition, bracing and taping significantly improved dynamic postural control in the sagittal plane by 6% (1.5-10.5%) P = 0.011 and 8% (2.9-13%) P = 0.004 respectively. Bracing significantly improved coronal plane stability compared to the control condition by 9% (3.8-14.1%) P = 0.002, and taping by 7% (1.6-12.6%) P = 0.013. SEBT scores revealed small but statistically significant differences (P < 0.05) between conditions in the anterior, posteromedial and composite scores, all showing a difference of between 1-2%. PRINCIPAL CONCLUSIONS: Patellar soft bracing and taping can improve dynamic postural stability during SEBT. It is possible to detect clinically important changes in lower limb stability from angular velocity using IMUs.