rivaroxaban and apixaban anticoagulant activity in whole blood

Modified ROTEM for the detection of rivaroxaban and apixaban anticoagulant activity in whole blood
BACKGROUND Rapid detection of the anticoagulant effect of oral factor Xa (FXa) inhibitors may be essential in several emergency clinical situations. Specific assays quantifying the drugs are performed in plasma and require a turnaround time that is too long to be useful in emergency situations. Rotational thromboelastometry (ROTEM) is a whole blood coagulation assay of blood viscoelasticity and could be of interest for FXa inhibitor detection in emergency. However, conventional ROTEM reagents only detect high amounts of inhibitors. OBJECTIVE The aim of this study was first to assess the effect of whole blood components on the viscoelastic measurement of the effects of FXa inhibitors, an second to evaluate whether a modified ROTEM, triggered with a low amount of tissue factor and a saturating amount of phospholipid vesicles, can reliably detect low levels of FXa inhibitor activity in whole blood. DESIGN Diagnostic test study. SETTINGS A university research laboratory. From November 2014 to April 2016. PATIENTS Sixty-six patients: 30 treated with rivaroxaban, 17 with apixaban and 19 without treatment. INTERVENTION ROTEM was triggered with 2.5 pmol l−1 of tissue factor and 10 μmol l−1 of phospholipid vesicles. MAIN OUTCOME MEASURES Modified ROTEM parameters were measured in different experimental conditions: platelet-poor plasma (PPP), platelet-rich plasma, PPP supplemented with fibrinogen and reconstituted whole blood with various haematocrit levels adjusted between 30 and 60%. Modified ROTEM was further validated using whole blood from patients who were either treated or not treated with FXa inhibitors. RESULTS Modified ROTEM allowed detection of as little as 25 ng ml−1 FXa inhibitors in PPP, with at least a 1.4-fold increase of the clotting time (P ≤ 0.02). Neither changes of fibrinogen concentration nor variations of platelet count or haematocrit precluded FXa inhibitor detection. A lengthened modified ROTEM clotting time of more than 197 s allowed detection of FXa inhibitor concentrations above 30 ng ml−1 in whole blood with 90% sensitivity and 85% specificity. CONCLUSION Modified ROTEM may be applicable in emergency situations for the detection of FXa inhibitors in whole blood. Correspondence to Charles M. Samama, MD, PhD, FCCP, Department of Anaesthesia and Intensive Care Medicine, Cochin University Hospital, 27 rue du Faubourg St Jacques, 75014 Paris, France Tel: +33 1 42 34 85 51/+33 6 62 14 86 64; fax: +33 1 58 41 14 15; e-mail: marc.samama@aphp.fr Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal's Website (www.ejanaesthesiology.com). © 2019 European Society of Anaesthesiology

Laboratory

Urinary N-acetyl-beta-d-glucosaminidase levels in diabetic adults Eiya Bibiana Omozee, Enajit Ibiene Okaka, Andrew Efosa Edo, Leonard Fedinard Obika Journal of Laboratory Physicians 2019 11(1):1-4 Diabetes mellitus (DM) is known to be one of the most common causes of end-stage renal disease. The disease is usually not detected on time, because of the large functioning reserve of the kidney. Currently used markers (serum creatinine, creatinine clearance, urea, and electrolytes) remain relatively normal even when more than 50% of the renal nephron is not functioning. The aim of this study was to determine the level of urinary N-acetyl-beta-d-glucosaminidase (NAG) in diabetic adults in comparison with some currently used markers. A total of 56 diabetic patients between the ages of 23 and 63 were used for this study and 30 nondiabetic between the ages of 18 and 62 were used as control. The diabetic patients were classified into three groups based on how long they have been diagnosed: <2 years (25), 2–5 years (30), and >5 years (25). Spot midstream urine samples were collected into sterile containers, and blood samples were collected into plain tubes. All the analyses were done spectrophotometrically. Creatinine clearance was calculated using the Cockcroft–Gault Equation. There was a significant increase (P < 0.01) in NAG values of 2–5 years and above 5 years and control. The urinary microalbumin concentration of controls was significantly different (P < 0.05) only with those who have had DM for <2 years. Urinary creatinine concentration of control was significantly higher (P < 0.05) than values of all the diabetic groups. There was a significant increase (P < 0.01) in creatinine clearance of control group and those who have had DM for <2 years. It is thus concluded that urinary NAG can be used as an early marker in the diagnosis of diabetic nephropathy since urinary NAG increases first before the other markers analyzed in this current study begins to increase.

Clinical profile and determinants of short-term outcome of acute kidney injury: A hospital-based prospective study from Northeastern India Prasanta Kumar Bhattacharya, Akash Roy, Md. Jamil, Bhupen Barman, Subrahmanya V Murti, Patrick R Marak Journal of Laboratory Physicians 2019 11(1):5-10 CONTEXT: Acute kidney injury (AKI) is an outcome of multiple etiologies and is mostly reversible. Data on its incidence and outcome, particularly from India, are limited. AIMS: To study the etiology, clinical profile, and short-term prognosis in AKI. SETTINGS AND DESIGN: A hospital-based prospective observational study on AKI. SUBJECTS AND METHODS: Seventy-five AKI patients diagnosed by Acute Kidney Injury network criteria were selected. Patients with preexisting chronic kidney disease were excluded. STATISTICAL ANALYSIS USED: Data were compiled using the Statistical Package for the Social Sciences version 17. Regression analysis was done for determining the association of various variables for mortality. P < 0.05 was considered statistically significant. RESULTS: The mean age of patients was 41.09 ± 16.17 years with a male:female ratio of 1.42:1. Comorbidities were present in 37.3%, with diabetes mellitus (10.6%) and chronic liver disease (10.6%) being the most common. Fever was the most common (40%) presenting symptom, followed by oliguria (25.8%). Infection was the most common cause of AKI (56%), with sepsis in 26.7% followed by acute gastroenteritis in 17.3%. Pneumonia was the primary focus in 50% of cases with sepsis. Mean serum creatinine and urea at admission were 2.37 ± 0.90 and 92.44 ± 39.67 mg/dl, respectively. Serum creatinine rose progressively to 2.96 ± 1.18 and 3.26 ± 1.56 mg/dl at 24 and 48 h, respectively, since hospitalization. Majority of the cases (73.3%) were nonoliguric. Hemodialysis was necessary in 24% of cases. Mean hospital stay was 8.16 days. In-hospital mortality was 24%. Among survivors, 92.9% had complete renal recovery on discharge. Sepsis, need for hemodialysis, urea >100 mg/dl, and peak serum creatinine >3 mg/dl were contributors to mortality (P < 0.01). CONCLUSIONS: Infections, especially sepsis, were the most common cause of AKI. Hemodialysis was required in one-quarter of the patients. Sepsis, need for hemodialysis, and high creatinine were associated with a significantly higher mortality.

Serological evidence of human leptospirosis in patients with acute undifferentiated febrile illness from Uttarakhand, India: A pilot study Mohit Bhatia, Pradeep Kumar, Pratima Gupta, Puneet Kumar Gupta, Minakshi Dhar, Deepjyoti Kalita Journal of Laboratory Physicians 2019 11(1):11-16 CONTEXT: To the best of our knowledge, there are no reports of serological evidence of human leptospirosis from Uttarakhand state in India. AIMS: The aim of this study was to screen for serological evidence of leptospirosis in patients with acute undifferentiated febrile illness at a tertiary care teaching hospital in Uttarakhand. SETTINGS AND DESIGN: A pilot study was conducted from March to November 2017. SUBJECTS AND METHODS: Fifty-three adult patients who presented in Medicine outpatient Department with a history of fever of ≥7 up to 14 days duration with or without other associated symptoms such as a headache, rashes, myalgia, arthralgia, and conjunctival suffusion were enrolled in the study using convenience sampling technique. Blood samples of these patients were collected and subjected to peripheral smear examination for malaria parasites, dengue immunoglobulin M (IgM) immunochromatographic card test, IgM Typhidot, Leptospira and Scrub typhus IgM ELISA, respectively. Aerobic blood culture was performed in 24 cases. Relevant clinico-epidemiological details were obtained as per the pro forma formulated in accordance with the modified Faine's criteria. STATISTICAL ANALYSIS USED: Descriptive statistics. RESULTS: The study population consisted of 50.94% of males and 49.06% of females with a mean age ± standard deviation of 34.2 ± 15.2 years. Fifty febrile patients had additional symptoms of which myalgia was the most common (81.1%) followed by arthralgia (22.6%). Peripheral smears of all patients were negative for malaria parasites. Dengue and Typhidot IgM positivity was observed in two and eight patients, respectively. Six and five patients were tested positive by leptospira and scrub typhus IgM ELISA, respectively. Salmonella Typhi was isolated from blood sample of only one patient. Serum samples of two patients showed dual positivity. All six leptospira seropositive patients satisfied modified Faine's criteria. CONCLUSIONS: Leptospirosis is a seemingly unexplored infection in Uttarakhand and should be considered as a differential diagnosis in patients with acute undifferentiated febrile illness.

Detection of biofilm among uropathogenic Escherichia coli and its correlation with antibiotic resistance pattern Rashmi M Karigoudar, Mahesh H Karigoudar, Sanjay M Wavare, Smita S Mangalgi Journal of Laboratory Physicians 2019 11(1):17-22 BACKGROUND: Escherichia coli accounts for 70%–95% of urinary tract infections (UTIs). UTI is a serious health problem with respect to antibiotic resistance and biofilms formation being the prime cause for the antibiotic resistance. Biofilm can restrict the diffusion of substances and binding of antimicrobials. In this context, the present study is aimed to perform in vitro detection of biofilm formation among E. coli strains isolated from urine and to correlate their susceptibility pattern with biofilm formation. MATERIALS AND METHODS: A total of 100 E. coli strains isolated from patients suffering from UTI were included in the study. The identification of E. coli was performed by colony morphology, Gram staining, and standard biochemical tests. The detection of biofilm was carried out by Congo Red Agar (CRA) method, tube method (TM), and tissue culture plate (TCP) method. Antimicrobial sensitivity testing was performed by Kirby–Bauer disc diffusion method on Muller–Hinton agar plate. RESULTS: Of the 100 E. coli strains, 49 (49%) and 51 (51%) were from catheterized and noncatheterized patients, respectively. Biofilm production was positive by CRA, TM, and TCP method were 49 (49%), 55 (55%), and 69 (69%), respectively. Biofilm producers showed maximum resistance to co-trimoxazole (73.9%), gentamicin (94.2%), and imipenem (11.6%) when compared to nonbiofilm producers. Significant association was seen between resistance to antibiotic and biofilm formation with a P = 0.01 (<0.05). CONCLUSION: A greater understanding of biofilm detection in E. coli will help in the development of newer and more effective treatment. The detection of biofilm formation and antibiotic susceptibility pattern helps in choosing the correct antibiotic therapy.

Multidrug-resistant Acinetobacter septicemia in neonates: A study from a teaching hospital of Northern India Asifa Nazir Journal of Laboratory Physicians 2019 11(1):23-28 BACKGROUND: Acinetobacter species are typical nosocomial pathogens causing infections and high mortality, almost exclusively in compromised hospitalized patients. Acinetobacter sp. are intrinsically less susceptible to antibiotics and have propensity to acquire resistance. Multidrug-resistant (MDR) Acinetobacter sp. blood infection in the neonatal intensive care unit patients create a great problem in hospital settings. AIMS: A prospective data analysis was performed over a one year period of all neonates admitted with sepsis who developed Acinetobacter infection and their antibiotic susceptibility pattern was carried out. MATERIALS AND METHODS: Blood samples of infected neonates were collected aseptically and cases of Acinetobacter septicemia were identified. Speciation of Acinetobacter species was done. Various risk factors were identified and their drug-sensitivity test was performed. RESULTS: The incidence of neonatal septicemia due to Acinetobacter species was 13.7% (49/357). Predominant species isolated was Acinetobacter baumannii (98%). The major symptoms were lethargy and poor feeding. The major signs were tachypnea, intercostal retraction, and respiratory distress. The major fetal risk factors were low birth weight and prematurity. High degree of resistance was observed to the various antibiotics used. Majority of the isolates (95.9%) were MDR while 93.68% were resistant to carbapenems as well as extensively drug resistant. However, all the strains were sensitive to colistin. CONCLUSION: MDR Acinetobacter septicemia in neonatal patients is becoming alarmingly frequent and is associated with significant mortality and morbidity. Therefore, rational antibiotic use is mandatory along with an effective infection control policy in neonatal intensive care areas of each hospital to control Acinetobacter infection and improve outcome.

Volume, conductivity, and scatter parameters of leukocytes as early markers of sepsis and treatment response Parul Arora, Praveen Kumar Gupta, Raghavendra Lingaiah, Asok Kumar Mukhopadhyay Journal of Laboratory Physicians 2019 11(1):29-33 INTRODUCTION: Morphologic changes in the size and granularity of leukocytes seen in sepsis could be measured using the volume, conductivity, and scatter (VCS parameters) from the automated hematology analyzers. The objective of this study is to find the clinical usefulness of VCS parameters as possible indicators of sepsis and to determine the effect of treatment on these parameters. METHODS: This observational study was conducted in a tertiary level hospital in India. Hemogram and VCS parameters obtained from LH 750 (Beckman coulter, Fullerton, CA) from 134 proven blood culture-positive cases of sepsis were reviewed on the day of culture positivity (day 0), day 3, and day 7 were analyzed and compared with those of samples from otherwise healthy 100 participants. Statistical analysis of data was done, and cutoff value was established using receiver-operator characteristic curve. RESULTS: Out of 134 culture-positive cases, 55.2% (n = 74) Gram-negative and 44.8% (n = 60) Gram-positive bacteria were isolated. The mean neutrophil volume (MNV) and mean monocyte volume (MMV) were higher in the sepsis group compared to that of the control group (165.43 ± 18.21 vs. 140.59 ± 7.6, P = 0.001 for MNV and 179.8 ± 14.16 vs. 164.54 ± 9.6, P = 0.001 for MMV). A significant decrease in MNV and MMV was observed with the initiation of the treatment. Significant changes in scatter and conductivity parameters were also noticed. A cutoff value of 150.2 for MNV gave a sensitivity and specificity of 79.1% and 95%, respectively, with an area under the curve (AUC) of 92.3%. With a cutoff of 168.3, MMV had a sensitivity of 80.6% and specificity of 77.5%, AUC of 83%. CONCLUSION: VCS parameters such as MNV and MMV can be easily obtained by an automated hematology analyzer and could be used for early detection and therapeutic response in sepsis.

A 5-year surveillance on antimicrobial resistance of Acinetobacter isolates at a level-I trauma centre of India Minu Kumari, Priyam Batra, Rajesh Malhotra, Purva Mathur Journal of Laboratory Physicians 2019 11(1):34-38 INTRODUCTION: Acinetobacter spp. has emerged as a major cause of nosocomial outbreaks. Multiple antibiotic resistance is an important problem in Acinetobacter isolates in recent years. The aim of this study was to evaluate the rate of antimicrobial resistance and changes in resistance pattern over a period of 5 years (2012–2016) in Acinetobacter spp. isolated from trauma patients. MATERIALS AND METHODS: Acinetobacter spp. was identified by VITEK 2 and antibiotic susceptibility of isolates was investigated by disc-diffusion method and VITEK 2 automated system. Interpretation of susceptibility results was based on the Clinical and Laboratory Standards Institute guidelines. RESULTS: Out of the total 16,210 isolates obtained throughout the period of 5 years, Acinetobacter spp. accounted for 3744 (28.9%). Out of which, the species which was maximally isolated was Acinetobacter baumannii (98.5%), followed by Acinetobacter lwoffii (1.4%) and Acinetobacter hemolyticus (0.1%). The highest number of clinical isolates of Acinetobacter were recovered from neurosurgical ward (n = 1210), followed by the neurosurgical intensive care unit (ICU) (n = 1000) and surgical ICU (n = 948) and the most common sample of Acinetobacter isolation was from tracheal aspirate (37.1%), followed by wound swab (18.8%). The highest level of resistance was observed against ciprofloxacin (96%), followed by cefepime (95%), ceftazidime (95%), piperacillin (95%), and amikacin (92%). The trend of antibiotic resistance was found to be statistically significant (P < 0.001) for most of the antibiotics being tested such as amikacin and carbapenems. CONCLUSION: The high rate of antibiotic resistance of the Acinetobacter strains indicated that there is an urgent need for controlled antibiotic usage and appliance of hospital infection control measures.

Reconsidering azithromycin disc diffusion interpretive criteria for Salmonellae in view of azithromycin MIC creep among typhoidal and nontyphoidal salmonella Sadia Khan, Parvathy Kurup, Vivek Vinod, Raja Biswas, Gopala Krishna Pillai, Anil Kumar Journal of Laboratory Physicians 2019 11(1):39-44 PURPOSE: Enteric fever continues to be an important public health challenge for the developing world. With the emergence of fluoroquinolone resistance in Salmonellae spp. azithromycin is increasingly being used for oral treatment of enteric fever. We investigated the antibiotic susceptibility pattern of azithromycin in Salmonellae spp. isolates from a tertiary care hospital to detect emerging resistance. METHODS: The study assessed the reliability of disc diffusion as a screening test to detect azithromycin resistance by comparing it with the minimum inhibitory concentrations (MICs) of the drug in 100 Salmonellae spp. strains. The strains of Salmonellae spp. showing resistance to azithromycin were further investigated for resistance markers – mphA, mphB, and mef B genes. RESULTS: This study was conducted on 100 Salmonella enterica strains recovered from blood culture samples between 2013 and 2017. Among these isolates, 18 showed resistance to azithromycin by disc diffusion methodology with zones of inhibition <13 mm. MIC of 6 of these isolates were ≥32 mg/L. The mean MIC of azithromycin increased from 5 mg/L in 2013 to 24 mg/L in 2017. Azithromycin consumption as defined daily doses per 1000 patient days also showed an increase over the past 4 years. CONCLUSION: Azithromycin disc diffusion diameter interpretations as recommended by Clinical and Laboratory Standards Institute can mislabel a few sensitive strains as resistant. Azithromycin resistance is emerging in typhoidal and nontyphoidal Salmonella. MphA gene is associated with high MICs in nontyphoidal Salmonella spp.

Typing of Neisseria gonorrhoeae isolates by phenotypic and genotypic techniques in New Delhi, India Seema Sood, Neeraj Mahajan, Rajendra Singh, Sonu Kumari Agrawal, Trupti Shende, Arti Kapil, Hemanta K Kar, Vinod K Sharma Journal of Laboratory Physicians 2019 11(1):45-50 BACKGROUND: The objective of this study is to investigate gonococcal isolates using phenotypic and genotypic methods. METHODOLOGY: Sixty gonococcal isolates obtained were examined. Strains were divided into 9 resistant phenotypes: Chromosomally mediated penicillin-resistant Neisseria gonorrhoeae (CMRNGP), penicillinase-producing NG (PPNG), chromosomally mediated tetracycline-resistant NG (CMRNGT), TRNG, PPNG and TRNG, CMRNGPT, quinolone resistant NG (QRNG), Azithro R, and decreased susceptibility (DS) to ceftriaxone. These isolates were also subjected to auxotyping and NG-multi-antigen sequence typing (MAST). RESULTS: Of 60 isolates, 32 (53.33%) PPNG and only one was CMRNGP; 16 (26.66%) were CMRNGT, while 18 (30%) were TRNG. Both PPNG and TRNG found in 13 (21.66%) and none were CMRNGPT. QRNG was seen in 93.33%, 5% Azithromycin R, and 6.66% were DS to ceftriaxone. Based on auxotyping, 24 (40%) nonrequiring, 16 (26.66%) were proline requiring, 13 (21.66%) arginine requiring while 7 (11.66%) belonged to others. The most common ST was 6058 (32.5%). The discriminatory indices of antibiogram, auxotyping and NG-MAST were 0.77, 0.72, and 0.95, respectively. CONCLUSIONS: NG-MAST is the method of choice for epidemiological studies.

Correlation of vascular endothelial growth factor and vascular endothelial growth factor receptor-1 levels in serum and thyroid nodules with histopathological and radiological variables Gurkan Haytaoglu, Fatih Kuzu, Dilek Arpaci, Ayfer Altas, Murat Can, Figen Barut, Furuzan Kokturk, Sevil Uygun Ilikhan, Taner Bayraktaroglu Journal of Laboratory Physicians 2019 11(1):51-57 BACKGROUND/AIM: Vascular endothelial growth factor (VEGF) is a major cytokine in angiogenesis and has a role on aggressivity of various tumors. The expression of VEGF has been shown to increase in differential thyroid cancer. The aim of the study was to evaluate serum and intranodular VEGF (nVEGF) and VEGF receptor-1 (VEGFR-1) levels in patients with thyroid nodules and their relevance to ultrasonographic and pathological results. MATERIALS AND METHODS: A total of eighty patients were included in the study. Thyroid fine-needle aspiration biopsies were performed, and the levels of serum and nVEGF and VEGFR-1 were measured. Any possible correlations between serum and nVEGF, VEGFR-1, and biochemical/radiological variables were investigated. RESULTS: There were no significant differences between serum VEGF (sVEGF), nVEGF, sVEGFR-1, nVEGFR-1 levels, number of nodules, size of nodules, and benign and malignant ultrasonographic features. sVEGF and nVEGF were higher in malignant or suspicious nodules than that in benign nodules, but did not reach statistical significance (P > 0.05). sVEGFR-1 and nVEGFR-1 levels were higher in hyperthyroid patients than that in euthyroid patients (P < 0.05 and P = 0.003, respectively). nVEGFR-1 level was higher in hypothyroid patients than that in euthyroid patients (P = 0.016). sVEGF level was found to be higher in hyperactive nodules than that in others. Both sVEGFR-1 (P = 0.008) and nVEGF levels (P = 0.01) significantly increased with increasing age. nVEGFR-1 decreased with increasing body mass index (BMI) (P = 0.004). CONCLUSIONS: Our study showed the relationships of sVEGF, nVEGF, sVEGFR-1, and nVEGFR-1 levels with age, gender, BMI, and hyperthyroidism. To determine the role of VEGF/VEGFR-1 in thyroid nodules, further studies are required with a large number of patients.

Physical Medicine & Rehabilitation

Assessment of Usability and Task Load Demand Using a Robotic Assisted Transfer Device Compared to a Hoyer Advance for Dependent Wheelchair Transfers Objective Manual lifting can be burdensome for people who care for power wheelchair users. Though technologies used for dependent transfers are helpful, they have shortcomings of their own. This study compares the usability and task load demand of a novel robotic assisted transfer device to a clinical standard when performing dependent transfers. Design A cross-sectional study was conducted to assess caregivers (N=21) transferring a 56 kg mannequin with the Strong Arm and Hoyer Advance at three transfer locations. Feedback was gathered through qualitative surveys. Results Usability was significant in multiple areas important for transfers. Caregiver fatigue and discomfort intensity were reduced, and the Strong Arm was preferred at the three transfer locations. Device ease and efficiency favored Strong Arm at two stations as was discomfort frequency. Additionally, physical demand, frustration, and effort were significantly lower using Strong Arm compared to the Hoyer Advance. Conclusion Compared to the Hoyer, participants favored Strong Arm for transfer usability and task load demand. However, further Strong Arm developments are needed. Copyright © 2019 Wolters Kluwer Health, Inc. All rights reserved.

Evaluating the influence of social engagement on cognitive impairment and mobility outcomes within the Boston RISE cohort study OBJECTIVE We investigated the associations between mild cognitive impairment (MCI), social engagement (SE) and mobility. DESIGN We evaluated data from a cohort study of older adult primary care patients (N=430). Outcomes included self-reported function (Late-Life Function Instrument-LLFI) and performance based mobility (Short Physical Performance Battery score-SPPB). Linear regression models evaluated the association between MCI and mobility, MCI and SE, mobility measures and SE, and whether SE mediated the association between MCI status and mobility. RESULTS Participants with MCI had significantly lower mobility and lower SE as compared to those without MCI (LLFI: 53.5 vs. 56.9, p<.001; SPPB: 7.9 vs. 9.3, p<.001; SE score 44.9 vs. 49.0, p<.001). MCI was significantly associated with both LLFI and SPPB (LLFI β=-2.93, p= <.001; SPPB β=-1.26, p= <.001) and SE (β=-3.20, p= <.001). SE was significantly associated with both LLFI and SPPB (LLFI β=0.22; p= <.001; SPPB β=0.08; p= <.001). There was a positive association between SE and mobility (p-value <0.05). A mediator effect of SE was supported when evaluating the association between MCI and mobility. CONCLUSION Among older adult primary care patients at risk for mobility decline, higher levels of SE mitigate the association between MCI and mobility. Corresponding Author: Hannah Steere, MD, Spaulding Rehabilitation Hospital, 300 1st Ave, 2nd floor, Charlestown, MA, 02129, USA, Tel: 617-952-5243 | Fax: 617-952-5934 | Email: steere.hannah@gmail.com Author Disclosures: There are no competing interests or financial benefits to the authors to disclose. This work was supported by the National Institute on Aging (R01 AG032052-03), Eunice Kennedy Shriver National Institute of Child Health and Human Development (1K24HD070966-01), and the National Center for Research Resources in a grant to the Harvard Clinical and Translational Science Center (1 UL1 RR025758-01). The main results of this study have been presented as a poster presentation at the 2017 American Congress of Rehabilitation Medicine conference. This study has not been previously submitted to any journal. Copyright © 2019 Wolters Kluwer Health, Inc. All rights reserved.

Exercise training guidelines for multiple sclerosis, stroke, and Parkinson's disease: Rapid review and synthesis The translation of knowledge from exercise training research into the clinical management of multiple sclerosis (MS), stroke, and Parkinson's disease (PD) requires evidence-based guidelines that are uniformly recognizable by healthcare practitioners and patients/clients with these diseases. This paper synthesized resources that reported aerobic and resistance training guidelines for people with MS, stroke, and PD. Systematic searches yielded 25 eligible resources from electronic databases and websites or textbooks of major organizations. Data were extracted (exercise frequency, intensity, time, and type) and synthesized into recommendations per disease. Exercise guidelines for MS consistently recommended 2-3 days/week of aerobic training (10-30 minutes at moderate-intensity) and 2-3 days/week of resistance training (1-3 sets between 8-15 repetition maximum (RM)). Exercise guidelines for stroke recommended 3-5 days/week of aerobic training (20-40 minutes at moderate-intensity) and 2-3 days/week of resistance training (1-3 sets between 8-15 repetitions between 30-50% 1-RM). Exercise guidelines for PD recommended 3-5 days/week of aerobic training (20-60 minutes at moderate-intensity), and 2-3 days/week of resistance training (1-3 sets of 8-12 repetitions between 40-50% of 1-RM). This harmonization of exercise guidelines provides a prescriptive basis for healthcare providers, exercise professionals, and people with these diseases regarding disease-specific exercise programming. Correspondence to: Yumi Kim, MS, University of Alabama at Birmingham/Lakeshore Foundation Research Collaborative, 4000 Ridgeway Drive, Birmingham, AL 35209, USA; email: yumikim@uab.edu Authorship: YK: Article selection/screening, data extraction/synthesis, writing, editing, BL: Data cross-check, exercise guideline summary, writing, editing, TM: Reviewing, editing, MT: Reviewing, editing, SP: Reviewing, editing, JH: Exercise guideline summary, reviewing, writing, editing, RM: Exercise guideline summary, reviewing, writing, editing All the authors approved and critically revised the manuscript. FUNDING: This work was supported by the National Institute on Disability, Independent Living, and Rehabilitation Research (grant number 90REGE0002-01-00). The National Institute on Disability, Independent Living, and Rehabilitation Research is a Centre within the Administration for Community Living, Department of Health and Human Services. The contents of this manuscript do not necessarily represent the policy of these groups and you should not assume endorsement by the US Federal Government. CONFLICT OF INTEREST: The authors declared no potential conflicts of interest with respect to the research, authorship and/or publication of this article. Copyright © 2019 Wolters Kluwer Health, Inc. All rights reserved.

A Short History of Medical Expert Guidelines and How They Pertain to Tracheostomy Tubes and Physical Medicine and Rehabilitation Continuous noninvasive ventilatory support (CNVS) and mechanical insufflation exsufflation (MIE) have been used since 1953 to spare patients with ventilatory pump failure from ever requiring tracheostomy tubes for ventilatory support or secretion management. Today there are patients with spinal muscular atrophy type 1 who are 25 years old and CNVS dependent since 4 months or age, post-polio survivors CNVS dependent for 64 years, Duchenne muscular dystrophy patients over age 45 CNVS dependent for over 25 years, high level spinal cord injured patients CNVS dependent for over 20 years, and even lung disease patients dependent on CNVS. All these patients, although unweanable from ventilatory support and with little or no measurable vital capacity, can also be extubated to CNVS and MIE without resort to tracheotomies when necessary to continue CNVS. However, for various reasons, this is not cited in academic society expert guidelines. This article considers the extent of the damage being caused by this. This work was not funded. Copyright © 2019 Wolters Kluwer Health, Inc. All rights reserved.

Artificial Intelligence and Applications in PM&R Artificial intelligence methods are being applied broadly in society and increasingly in healthcare and research. Machine learning, a subset of artificial intelligence, represents the study of algorithms that improve automatically with experience. This article provides a basic overview of artificial intelligence, machine learning categories, common applications in the business sphere, advantages and disadvantages of utilizing this technology, and example applications in rehabilitation and other fields for contextual purposes. The study and implementation of machine learning and artificial intelligence can function to improve patient care and represents a burgeoning area of research. Correspondence: Dustin Anderson, MD. 12631 E 17th Ave, Aurora, CO 80045. dustin.anderson@ucdenver.edu Author Disclosures: None Competing Interests: None Funding or grants or equipment provided for the project from any source: None Financial benefits to the authors: None Details of any previous presentation of the research, manuscript, or abstract in any form: None Copyright © 2019 Wolters Kluwer Health, Inc. All rights reserved.

Randomized Trial on Comparison of the Efficacy of Extracorporeal Shock Wave Therapy and Dry Needling in Myofascial Trigger Points Objectives To compare the efficacy of radial extracorporeal shock wave therapy (ESWT) and dry needling (DN) in the treatment of myofascial trigger points (MTrPs) in the upper trapezius muscle. Design A total of 65 patients with MTrPs were randomly divided into ESWT group (n=32) and DN group (n=33). Patients received 3 weeks of treatment at one-week intervals in both groups Visual analogue scale (VAS), pressure pain threshold (PPT), Neck Disability Index (NDI) and shear modulus were evaluated pre-treatment, immediately post the first therapy, 1-month and 3-month after the completion of the third therapy. Results Significant improvements of VAS, PPT, NDI scores were observed at all time points post-treatment (p<0.01) in both treatment groups. The shear modulus of MTrPs was reduced in both DN group (p<0.05) and ESWT group (p<0.01) immediately after the first treatment. Significant reductions in shear modulus were maintained up to 3-month post-treatment in both groups (p<0.01). There were no significant differences between the radial ESWT group and DN group. Conclusions The ESWT is as effective as DN for relieving pain, improving function and reducing shear modulus for patients with MTrPs following a series of three treatments. Shuo Luan and Zhi-min Zhu contributed equally to this work. Co-Corresponding authors: Chao Ma and Shaoling Wu are both corresponding authors of this article. All correspondence should be addressed to: Chao Ma, MD, PhD and Shaoling Wu, MD, PhD, Department of Rehabilitation Medicine, Sun Yat-sen Memorial Hospital, No.107 Yanjiang West Road, Guangzhou, 510120, China Disclosures: This study was supported by a grant from National Natural Science Foundation of China (81771201, 81671088), Natural Science Foundation of Guangdong (2016A030311045), Guangzhou science and technology plan projects (201807010050) and Sun Yat-Sen Clinical Research Cultivating Program (SYS-C-201704). Financial disclosure statements have been obtained, and no conflicts of interest have been reported by the authors or by any individuals in control of the content of this article. Copyright © 2019 Wolters Kluwer Health, Inc. All rights reserved.

Understanding measures of association: A primer with examples from rehabilitation research Understanding measures of associations, how they are calculated, what they mean, and how to compare them is an important part of understanding clinical and health research. The relative risk (RR) and odds ratio (OR) are the two most common used measures of association in medical research. The appropriate use of these statistics to estimate the association between treatment or risk factor and outcome in research studies depends on the methodology and design of the study. The aim of this article is to cover basics of odds ratio and relative risk as the most important measures for the association between an exposure and an outcome. We use a clinical scenario as an example of their uses and demonstrate their calculation. Corresponding author: Dinesh Kumbhare, MD, PhD, FRCPC, FAAPMR, 550 University Avenue, Suite 7-131, Toronto, Ontario M5G 2A2, dinesh.kumbhare@uhn.ca, Telephone: 416-597-3422 x 4612 Author Disclosures: All the authors report no conflict of interest for the completion of this manuscript. Also, no funding was received. Copyright © 2019 Wolters Kluwer Health, Inc. All rights reserved.

Exercise-induced bilateral rectus femoris injury No abstract available

Minimal Clinically Important Difference of Shoulder Outcome Measures and Diagnoses: A Systematic Review Objective Patient-reported outcome scales determine response to treatment. The minimal clinically important difference (MCID) of these scales is a measure of responsiveness: the smallest change in a score associated with a clinically important change to the patient. This study sought to summarize the literature on MCID for the most commonly reported shoulder outcome scales. Design A literature search of PubMed and EMBASE databases identified 193 citations, twenty-seven of which met the inclusion/exclusion criteria. Results For rotator cuff tears, a MCID range of 9-26.9 was reported for American Shoulder and Elbow Surgeons (ASES), 8 or 10 for Constant, and 282.6-588.7 for the Western Ontario Rotator Cuff Index (WORC). For patients who underwent arthroplasty, a MCID range of 6.3-20.9 was reported for ASES, 5.7-9.4 for Constant, and 14.1-20.6 for the Shoulder Pain and Disability Index (SPADI). For proximal humeral fractures, a MCID range of 5.4-11.6 was reported for Constant and 8.1-13.0 for Disability of the Arm, Shoulder, and Hand (DASH). Conclusion A wide range of MCID values was reported for each patient population and instrument. In the future, a uniform outcome instrument and MCID will be useful to measure clinically meaningful change across practices and the spectrum of shoulder diagnoses. Corresponding Author: Nitin B. Jain, MD, MSPH, Department of Physical Medicine and Rehabilitation, Vanderbilt University Medical Center, 2201 Children's Way, Suite 1318, Nashville, TN 37212, United States of America, Phone: (615) 936-8508; Fax: (615) 322-7454, Email: nitin.jain@vanderbilt.edu Source of Funding: Dr. Jain is/was supported by funding from NIAMS 1K23AR059199 and 1U34AR069201. Copyright © 2019 Wolters Kluwer Health, Inc. All rights reserved.

Assessing the Accuracy of Ultrasound Guided Needle Placement in Sacroiliac Joint Injections Objective The aim of this study was to assess the accuracy of ultrasound guided needle placement for sacroiliac joint injections. Design Institutional Review Board (IRB) approval was gained for a prospective cohort study of fifty patients (N=50). Study patients who were referred for sacroiliac joint injections for sacroiliac joint mediate pain, and met inclusion/exclusion criteria, were enrolled in the study. Each patient underwent needle placement with ultrasound guidance in the procedure suite. After the needle was placed with the ultrasound guidance, fluoroscopy was utilized to confirm correct placement via contrast injection confirming a sacroiliac joint arthrogram. The arthrogram was confirmed via the performing physician and radiologist. Results The placement of the needle with ultrasound guidance into the sacroiliac joint was confirmed successful in 96% (48/50) patients by fluoroscopic arthrogram. The two patients with unsuccessful arthrograms following initial placement of the needle with ultrasound were morbidly obese. There was intra-vascular uptake during the arthrogram of one patient who had a successful arthrogram. Conclusions Ultrasound-guided injection of the sacroiliac joint is successful and accurate upon confirmation of fluoroscopic arthrogram and should be utilized as an imaging modality for needle guidance. Correspondence: Arthur Jason De Luigi, DO, MHSA, 10825 N. 140th Way, Scottsdale, AZ 85259, 301793-2136, ajweege@yahoo.com Competing Interests-None for any author Funding or grants or equipment provided for the project from any source-None for any author Financial benefits to the authors-None to any author Details of any previous presentation of the research, manuscript, or abstract in any form: None Copyright © 2019 Wolters Kluwer Health, Inc. All rights reserved.

Anaesthesiology

Improvement in postoperative pain control by combined use of intravenous dexamethasone with intravenous dexmedetomidine after interscalene brachial plexus block for arthroscopic shoulder surgery: A randomised controlled trial BACKGROUND Intravenous dexamethasone or dexmedetomidine is reported to prolong the duration of analgesia after single-shot interscalene brachial plexus block (ISBPB). However, the effect of co-administration of these agents on the duration of analgesia has not been evaluated. OBJECTIVES We evaluated the difference in time to first rescue analgesic request between patients receiving co-administered intravenous dexamethasone and dexmedetomidine and patients receiving intravenous dexamethasone alone after single-shot ISBPB for arthroscopic shoulder surgery. DESIGN A prospective, randomised controlled study. SETTING A single tertiary care centre, study period from August 2017 to January 2018. PATIENTS Sixty-six patients undergoing arthroscopic shoulder surgery with ISBPB with 15 ml of 0.5% ropivacaine with 1 : 200 000 epinephrine. INTERVENTIONS We randomly assigned the patients to one of three groups: intravenous 0.9% saline (control), intravenous dexamethasone 0.11 mg kg−1 (D1 group), or co-administered intravenous dexamethasone 0.11 mg kg−1 and intravenous dexmedetomidine 1.0 μg kg−1 (D2 group). MAIN OUTCOME MEASURES The primary outcome was the time to first rescue analgesic request. RESULTS The median [interquartile range] time to first rescue analgesic request was significantly longer for the D2 group (66.3 h [23.3 to 72]) than the D1 (17.4 h [14.9 to 36], P = 0.002) and control (10.9 h [10.1 to 12.2], P < 0.001) groups. The D1 and D2 groups both had reduced pain scores, reduced postoperative opioid consumption, less sleep disruption and improved patient satisfaction compared with the control group. There were no significant elevations in blood glucose concentrations in patients receiving dexamethasone (D1 and D2 groups) compared with the control group at postoperative day 1. CONCLUSION Co-administration of intravenous dexamethasone (0.11 mg kg−1) with dexmedetomidine (1.0 μg kg−1) significantly prolonged the time to first rescue analgesic request after single-shot ISBPB in patients undergoing arthroscopic shoulder surgery. TRIAL REGISTRATION Clinical Trial Registry of Korea; https://cris.nih.go.kr/cris/index.jsp and identifier: KCT0002569. Correspondence to Justin S. Ko, Department of Anaesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon ro, Gangnam gu, Seoul 06351, South Korea Tel: +82 2 3410 2454; fax: +82 2 3410 0361; e-mail: jsko@skku.edu © 2019 European Society of Anaesthesiology

Is 'anxiety sensitivity' predictive of postoperative nausea and vomiting?: A prospective observational study BACKGROUND Postoperative nausea and vomiting (PONV) is an extremely distressing side effect for patients. Despite PONV prophylaxis guided by well established scoring systems, the incidence of PONV is still high. OBJECTIVE The aim of the current study was to investigate the predictive value of anxiety sensitivity as an additional independent risk factor for PONV in patients with an increased risk of PONV. DESIGN A noninterventional, observational study. SETTING A tertiary care university hospital. PATIENTS Patients with an increased risk of PONV (i.e. female, nonsmoking) undergoing elective surgery (general, gynaecological, urological, musculoskeletal or neurosurgical) under general anaesthesia. MAIN OUTCOME MEASURES The number of patients with anxiety sensitivity assessed pre-operatively with the Anxiety Sensitivity Index-3 questionnaire, the number of patients experiencing PONV, predictive value of anxiety sensitivity compared with other established risk factors for PONV. RESULTS Some 41.5% of the patients experienced PONV within the first 24 h after surgery. In these patients increased anxiety sensitivity (Anxiety Sensitivity Index-3 score higher than seven points) was associated with a five-fold increase in the odds ratio (OR) for PONV. From the regression model, the risk of PONV was increased by lack of PONV prophylaxis (OR, 3.68), the postoperative administration of opioids (OR, 3.60) and patient age (OR, 1.03), but laparoscopic surgery did not increase the risk. CONCLUSION In addition to the well established risk factors, anxiety sensitivity can help to predict the risk of PONV. It seems justifiable to add psychological factors such as anxiety sensitivity to PONV risk-scores. PONV prophylaxis should be considered when anxiety sensitivity is high. TRIAL REGISTRATION ClinicalTrials.gov identifier: NCT01875120. Correspondence to Rita Laufenberg-Feldmann, MD, Department of Anaesthesiology, University Medical Centre of the Johannes Gutenberg University Mainz, Langenbeckstrasse 1, D-55131 Mainz, Germany Tel: +49 6131 177248/+49 6131 176751; fax: +49 06131 176209; e-mail: rita.laufenberg@unimedizin-mainz.de Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal's Website (www.ejanaesthesiology.com). © 2019 European Society of Anaesthesiology

Intra-operative high inspired oxygen fraction does not increase the risk of postoperative respiratory complications: Alternating intervention clinical trial BACKGROUND The WHO recommends routine intra-operative and early postoperative use of high inspired oxygen concentrations (hyperoxia). However, a high intra-operative inspired oxygen fraction (FiO2) might result in an increased risk of postoperative respiratory complications. AIM To test the hypothesis that intra-operative FiO2 of 80% compared with 30% inspired oxygen decreases the postoperative ratio of arterial saturation to fraction of inspired oxygen (SpO2/FiO2). Secondarily, to evaluate whether an intra-operative inspired FiO2 of 80% increases the incidence of pulmonary complications. DESIGN Posthoc subanalysis of a large alternating cohort trial. SETTING Cleveland Clinic, Cleveland, United States, from 2013 to 2016. PATIENTS Adults having colorectal surgery. Cases lasting less than 2 h, re-operations on the same hospitalisation, and cases with missing intra-operative or postoperative data were excluded. INTERVENTION Maintaining intra-operative FiO2 at 30 or 80% and alternating this management every 2 weeks for a study period of 39 months. MAIN OUTCOME Minimal SpO2/FiO2 ratio value in the postanaesthesia care unit. Secondary outcome was a composite of postoperative pulmonary complications throughout hospitalisation. RESULTS A total of 5056 patients were included. Groups were well balanced on all demographic, baseline and procedural variables. Median time-weighted averages of intra-operative FiO2 in the 30 and 80% groups were 43% (IQR 38 to 54%, N=2486) and 81% (IQR 78 to 82%, N=2570), respectively. No difference was found in the lowest SpO2/FiO2 ratio (estimated median difference 0 [95% confidence interval: 0, 0], P = 0.91). The incidence of postoperative pulmonary complications was 16.3 and 17.6% in the 30 and 80% FiO2 groups, respectively (relative risk 1.07 [95% confidence interval: 0.95, 1.21], P = 0.25). CONCLUSION Intra-operative hyperoxia did not change the postoperative SpO2/FiO2 ratio or the risk for pulmonary complications. Clinicians should not refrain from using hyperoxia for fear of provoking respiratory complications. TRIAL REGISTRATION ClinicalTrials.gov identifier: NCT01777568. Correspondence to Alparslan Turan, MD, Department of Outcomes Research, Anesthesiology Institute, Cleveland Clinic, 9500 Euclid Ave P77, Cleveland, OH 44195, USA Tel: +1 216 445 9857; fax: +1 216 444 6135; e-mail: Turana@ccf.org Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal's Website (www.ejanaesthesiology.com). © 2019 European Society of Anaesthesiology

Metamizole vs. ibuprofen at home after day case surgery: A double-blind randomised controlled noninferiority trial BACKGROUND NSAIDs and paracetamol are the cornerstones of pain treatment after day case surgery. However, NSAIDs have numerous contraindications and consequently are not suitable in up to 25% of patients. Metamizole is a non-opioid compound with a favourable gastro-intestinal and cardiovascular profile compared with NSAIDs. OBJECTIVES The study aimed to assess if a combination of metamizole and paracetamol is noninferior to a combination of ibuprofen and paracetamol in treating pain at home after painful day case surgery. METHODS Two hundred patients undergoing elective ambulatory haemorrhoid surgery, arthroscopic shoulder or knee surgery, or inguinal hernia repair were randomly allocated to receive either metamizole and paracetamol (n=100) or ibuprofen and paracetamol (n=100) orally for 4 days between January 2016 and March 2017 in this double-blind, randomised, controlled, single-centre, noninferiority trial. Average postoperative pain intensity using a numerical rating scale and use of rescue medication were measured in the postanaesthesia care unit (PACU) and on postoperative days (POD) 1 to 3. A difference in mean numerical rating scale score of 1 point or less was considered noninferior. Adverse effects of study medication and satisfaction with study medication were measured on PODs 1 to 3 by telephone follow-up. RESULTS In the PACU, the difference in mean ± SD pain score between metamizole and paracetamol and ibuprofen and paracetamol was 0.85 ± 0.78. From POD 1 to 3, this difference was lower than 1, resulting in noninferiority. Rescue opioid consumption in the PACU and on PODs 1 and 3 was not significantly different between treatment groups. Rescue opioid consumption on POD2 was significantly higher in the ibuprofen and paracetamol group (P = 0.042). Adverse effects of study medication and overall patient satisfaction were similar in both groups. CONCLUSION Paracetamol/metamizole and paracetamol/ibuprofen are equally effective in treatment of acute postoperative pain at home after ambulatory surgery with comparable patient satisfaction levels. TRIAL REGISTRATION European Union Clinical Trials Register 2015-003987-35. Correspondence to Björn Stessel, MD, PhD, Department of Anesthesiology and Pain Medicine, Jessa Hospital, Hasselt, Belgium E-mail: bjornstessel@hotmail.com © 2019 European Society of Anaesthesiology

Recent Advances in Anesthesiology No abstract available

Flow-controlled ventilation during ear, nose and throat surgery: A prospective observational study BACKGROUND Flow-controlled ventilation (FCV) is a new mechanical ventilation mode that maintains constant flow during inspiration and expiration with standard tidal volumes via cuffed narrow-bore endotracheal tubes. Originating in manually operated 'expiratory ventilation assistance', FCV extends this technique by automatic control of airway flow, monitoring of intratracheal pressure and control of peak inspiratory pressure and end-expiratory pressure. FCV has not yet been described in a clinical study. OBJECTIVE The aim of this study was to provide an initial assessment of FCV in mechanically ventilated patients undergoing ear, nose and throat surgery and evaluate its potential for future use. DESIGN An observational study. SETTING Two German academic medical centres from 24 November 2017 to 09 January 2018. PATIENTS Consecutive patients (≥ 18 years) scheduled for elective ear, nose and throat surgery. Exclusion criteria were planned laser surgery, intended fibreoptic awake intubation, emergency procedures, increased risk of aspiration, American Society of Anesthesiologists (ASA) physical status more than III and chronic obstructive pulmonary disease classified as GOLD stage more than II. INTERVENTION Peri-operative use of FCV provided by a new type of ventilator (Evone) via a narrow-bore endotracheal tube (Tritube). MAIN OUTCOME MEASURES Minute volume, respiratory rate, intratidal tracheal pressure amplitude (Δp) and end-tidal CO2 (PetCO2) were recorded every 5 min. All adverse events were noted. Data are presented as median [IQR]. RESULTS Sixteen patients provided 15 evaluable data sets. A minute volume of 5.0 [4.4 to 6.4] l min−1 and a respiratory rate of 9 [8 to 11] min−1 generated a PetCO2 of 4.9 [4.8 to 5.0] kPa. Δp was 10 [9 to 12] cmH2O. Five adverse events were recorded: a tube obstruction due to airway secretions and four tube dislocations (two attributed to coughing, two not study-related). CONCLUSION FCV achieves adequate PetCO2 levels with minute volume and Δp in the normal range. Tritube's high flow resistance may increase the likelihood of tube dislocations if the patient coughs. Although further evaluation is necessary, FCV provides a new option for short-term mechanical ventilation. The successful operation of FCV with narrow-bore tubes contributes to the armamentarium for airway management. TRIAL REGISTRATION DRKS00013312 This is an open access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal. http://creativecommons.org/licenses/by-nc-nd/4.0 Correspondence to Dr. Johannes Schmidt, Department of Anaesthesiology and Critical Care, Medical Centre – University of Freiburg, Hugstetter Str. 55, 79106 Freiburg, Germany Tel: +49 761 270 26390; e-mail: johannes.schmidt@uniklinik-freiburg.de Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal's Website (www.ejanaesthesiology.com). © 2019 European Society of Anaesthesiology

Pre-operative assessment of 30-day mortality risk after major surgery: the role of the quick sequential organ failure assessment: A retrospective observational study BACKGROUND The quick Sequential Organ Failure Assessment (qSOFA) is intended for the assessment of the prognosis and risk of sepsis. It may also help predict the mortality risk of nonseptic patients. OBJECTIVE This study investigated the relationship between pre-operative qSOFA scores and 30-day mortality after major surgery. It also evaluated the predictive value of qSOFA scores combined with the American Society of Anesthesiologists (ASA) physical status and Charlson comorbidity index (CCI). DESIGN A retrospective observational study. SETTING Single tertiary academic hospital. PATIENTS Medical records of patients who underwent major surgery (estimated blood loss >500 ml; surgery time >2 h) between January 2010 and December 2017 were examined. MAIN OUTCOME MEASURES The qSOFA score was measured within 24 h before surgery, and its association with 30-day mortality was analysed using multivariable logistic regression. A receiver-operating characteristic curve analysis was used to investigate the predictive power of the pre-operative qSOFA scores combined with the ASA physical status and with CCI. RESULTS A total of 6336 patients were included in the final analysis, and 91 (1.4%) died within 30 days. The multivariable logistic regression analysis including all covariates indicated that 30-day mortality was 2.43-times higher for the score 1 group than for the score 0 group (P = 0.002), and it was 3.54-times higher for the score at least 2 group than for the score 0 group (P < 0.001). The area under the curve (AUC) of the pre-operative qSOFA, ASA physical status and CCI were 0.69, 0.55 and 0.57, respectively. When the pre-operative qSOFA score was combined with the ASA physical status or CCI, the AUCs were 0.73 and 0.72, respectively. CONCLUSION Higher pre-operative qSOFA scores within 24 h of surgery were associated with increased 30-day mortality. Pre-operative qSOFA scores have better predictive value for 30-day mortality when combined with the ASA physical status or CCI. Correspondence to Tak Kyu Oh, MD, Department of Anesthesiology and Pain Medicine, Seoul National University Bundang Hospital, Gumi-ro 173 Beon-gil, Bundang-gu, Seongnam 13620, Korea Tel: +82 31 787 7499; fax: +82 31 787 4063; e-mail: airohtak@hotmail.com Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal's Website (www.ejanaesthesiology.com). © 2019 European Society of Anaesthesiology

Pediatric Anesthesia: A Problem-Based Learning Approach No abstract available

Comparison of pre-oxygenation using spontaneous breathing through face mask and high-flow nasal oxygen: A prospective randomised crossover controlled study in healthy volunteers BACKGROUND High-flow nasal oxygen (HFNO) therapy has been proposed for pre-oxygenation before intubation, but the end-tidal fraction of oxygen (ETO2) obtained remains unknown. OBJECTIVE(S) To compare the ETO2 following a 3 min pre-oxygenation with HFNO and face mask. SETTING Operating room in a primary university hospital. DESIGN A prospective, randomised crossover study. PARTICIPANTS Fifty healthy volunteers. INTERVENTIONS Participants were randomly pre-oxygenated through spontaneous breathing 100% oxygen in a face mask and with HFNO (mouth closed, heated and humidified gas flow at 60 l min–1). In the face mask group, the ETO2 was measured continuously. In the HFNO group, the nasal cannula was quickly exchanged with a face mask while the subject held their breath at end inspiration and the ETO2 was measured after a deep expiration. The protocol ended when ETO2 reached 90% or otherwise at 6 min. MAIN OUTCOME MEASURES The primary endpoint was the ETO2 after 3 min of pre-oxygenation. Secondary endpoints were the proportion of participants with an ETO2 at least 90% and the time until the ETO2 at least 90%. RESULTS The ETO2 after 3 min of pre-oxygenation was 89 (2) % and 77 (12) % in the face mask and HFNO groups [difference 12% (95% confidence interval, 95% CI: 8 to 15]; P < 0.001), respectively. After 3 min of pre-oxygenation, 54 and 4% (P < 0.001) of volunteers had an ETO2 at least 90% in the face-mask and HFNO groups, respectively. After 6 min of pre-oxygenation, 96 and 46% (P < 0.001) of volunteers had an ETO2 at least 90% in the face-mask and HFNO groups, respectively. In the face mask group, the hazard ratio to achieve an ETO2 of 90% was 5.3 (95% CI: 3.2 to 8.9; P < 0.001). CONCLUSION Our study demonstrates that pre-oxygenation with HFNO is not a reliable method of pre-oxygenation before the induction of anaesthesia. TRIAL REGISTRATION clinical trial NCT03399695. Correspondence to Jean-Luc Hanouz, Service d'Anesthésie Réanimation (niveau 6), CHU de Caen, Av Côte de Nacre, 14033 CAEN Cedex, France E-mail: hanouz-jl@chu-caen.fr © 2019 European Society of Anaesthesiology

Modified ROTEM for the detection of rivaroxaban and apixaban anticoagulant activity in whole blood BACKGROUND Rapid detection of the anticoagulant effect of oral factor Xa (FXa) inhibitors may be essential in several emergency clinical situations. Specific assays quantifying the drugs are performed in plasma and require a turnaround time that is too long to be useful in emergency situations. Rotational thromboelastometry (ROTEM) is a whole blood coagulation assay of blood viscoelasticity and could be of interest for FXa inhibitor detection in emergency. However, conventional ROTEM reagents only detect high amounts of inhibitors. OBJECTIVE The aim of this study was first to assess the effect of whole blood components on the viscoelastic measurement of the effects of FXa inhibitors, an second to evaluate whether a modified ROTEM, triggered with a low amount of tissue factor and a saturating amount of phospholipid vesicles, can reliably detect low levels of FXa inhibitor activity in whole blood. DESIGN Diagnostic test study. SETTINGS A university research laboratory. From November 2014 to April 2016. PATIENTS Sixty-six patients: 30 treated with rivaroxaban, 17 with apixaban and 19 without treatment. INTERVENTION ROTEM was triggered with 2.5 pmol l−1 of tissue factor and 10 μmol l−1 of phospholipid vesicles. MAIN OUTCOME MEASURES Modified ROTEM parameters were measured in different experimental conditions: platelet-poor plasma (PPP), platelet-rich plasma, PPP supplemented with fibrinogen and reconstituted whole blood with various haematocrit levels adjusted between 30 and 60%. Modified ROTEM was further validated using whole blood from patients who were either treated or not treated with FXa inhibitors. RESULTS Modified ROTEM allowed detection of as little as 25 ng ml−1 FXa inhibitors in PPP, with at least a 1.4-fold increase of the clotting time (P ≤ 0.02). Neither changes of fibrinogen concentration nor variations of platelet count or haematocrit precluded FXa inhibitor detection. A lengthened modified ROTEM clotting time of more than 197 s allowed detection of FXa inhibitor concentrations above 30 ng ml−1 in whole blood with 90% sensitivity and 85% specificity. CONCLUSION Modified ROTEM may be applicable in emergency situations for the detection of FXa inhibitors in whole blood. Correspondence to Charles M. Samama, MD, PhD, FCCP, Department of Anaesthesia and Intensive Care Medicine, Cochin University Hospital, 27 rue du Faubourg St Jacques, 75014 Paris, France Tel: +33 1 42 34 85 51/+33 6 62 14 86 64; fax: +33 1 58 41 14 15; e-mail: marc.samama@aphp.fr Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal's Website (www.ejanaesthesiology.com). © 2019 European Society of Anaesthesiology

Medicine

Cardiac outcomes after successful kidney transplantation Ahmed Hassan, Hala I Mohamed, Yasser A Hendy, Hala M Allam, Mohamed K Mohamed Journal of Medicine in Scientific Research 2018 1(4):219-226 Aim The aim of this study was to investigate the effects of renal transplantation on cardiac function and morphology in patients with ESRD on regular hemodialysis at the post-transplant period. Background End stage renal disease (ESRD) is considered an overall general health issue related to increased morbidity & mortality. The mortality rate among cases with ESRD who have been experiencing dialysis has been approximately seven times higher than for comparable cases in the general population and has been to a great extent related to cardiovascular causes. Cardiac diseases have been common in cases with chronic kidney disease (CKD). About 75% of cases with CKD who begin dialysis have left ventricular hypertrophy, left ventricle dilatation or diminished left ventricle functional shortening; these cardiac anomalies keep on progressing during the first year of hemodialysis. Besides these changes, impairment of diastolic function has been also expected in these cases. For example, Left ventricular hypertrophy has been a very common pathological condition in cases with ESRD and considered as an independent risk variable for death and cardiac disease. Generally, many risk variables including uremic toxins, fluid retention & chronic volume over-load, anemia, hypoalbuminemia, hyperparathyroidism, arterio-venous fistula and pressure over-load were involved in the pathogenesis for Left Ventricular Hypertrophy in cases with ESRD. Renal transplantation is a well-established treatment for ESRD, allowing most patients to return to a satisfactory quality of life. It is the most acceptable treatment modality for the patients with ESRD, which improves some complications of renal failure such as chronic uremia and volume overload. Methods This cross sectional study was done on 40 kidney transplant recipients enrolled from the patients in the NIUN according to the inclusion and exclusion criteria. We compared echocardiographic findings and some cardiac risk factors after transplantation with those done before transplantation. Results There was highly significant reduction with respect to serum creatinine, blood urea, phosphorus. Comparison of echocardiographic findings between the pre-transplant period and post-transplant period. Ejection fraction (EF) was significantly increased at the post-transplant period while left ventricular systolic dimension (LVSD), left ventricular diastolic dimension (LVDD), and LVH showed a significant decrease after transplantation. Conclusions We have found that cardiac parameters showed significant improvement after transplantation as well as cardiac risk factors including anemia, hyperparathyroidism and volume & pressure overload.

Hepatic encephalopathy in patients with diabetes mellitus El-Saied Shaheen, Helmy M Elshazly, Noha Abd Allah Journal of Medicine in Scientific Research 2018 1(4):227-230 Background and aim of the work Hepatic encephalopathy (HE) is a complex frequent neuropsychiatric manifestation of chronic and acute liver disease with disturbance of psychomotor, intellectual, cognitive, behavioral, and fine motor function of varying severity. Diabetes mellitus (DM) exacerbates progression of hepatic fibrosis. Recently, a meta-analysis study concluded that type 2 DM was associated with relative 1.5-fold increased risk for clinically defined Alzheimer disease and 2.5 for vascular dementia compared with nondiabetic individuals; furthermore, one recent prospective study showed that elevated blood glucose in the absence of DM increased the risk of dementia. Given the high prevalence of DM in the liver cirrhosis population, a better understanding of the effect of DM offers significant opportunities to improve patient outcome. Aim of the work To determine the relationship between duration of DM and blood sugar level and increase risk of the occurrence of HE in patients with liver cirrhosis. Patients and methods This study was carried out on 100 patients with cirrhosis with DM admitted between July 2017 and July 2018 in Internal Medicine Department, Shebin Elkom Teaching Hospital, Menoufia, Egypt. They were categorized into two groups according to the presence or absence of HE. Group 1 included 50 cirrhotic diabetic patients with HE and group 2 included 50 cirrhotic diabetic patients without HE. All patients in the study were subjected to a thorough physical examination; laboratory investigations, including complete blood picture, liver function tests, hepatitis B virus surface antigen, hepatitis C virus antibody, renal function tests, serum ammonia level, fasting and postprandial blood sugar, and glycated hemoglobin; tests to detect the presence of autonomic neuropathy (tilt-table test and diurnal variation of blood pressure measurement); and abdominal ultrasonography. Results The present study found a significant increase in fasting and postprandial blood glucose, glycated hemoglobin, and duration of DM in group 1 versus group 2. Positive tilt-table test and positive posture hypotension were highly significant in group 1 versus group 2. Conclusion Patients with cirrhosis with long-standing and uncontrolled DM are more likely to developed HE. Autonomic neuropathy, which may complicate patients with cirrhosis with long-standing uncontrolled diabetes, may play a role in the pathogenesis of HE in these patients.

Nonalcoholic fatty liver disease and outcomes in patients with acute coronary syndrome El-Saied Shaheen Journal of Medicine in Scientific Research 2018 1(4):231-233 Background According to the results of longitudinal cohort study, patients with nonalcoholic fatty liver disease (NAFLD) were found to have a higher mortality owing to coronary heart disease than the liver cirrhosis. Patients with NAFLD may also have a higher prevalence of subclinical atherosclerosis independent of established cardiovascular risk factor. Patients and methods This study was performed at Shebin El-Kom Teaching Hospital from January 2018 to March 2018. All consecutive patients with nonfatal acute coronary syndrome (ACS) admitted were included in this study. Patients with excessive alcohol consumption, patients with established cirrhosis, and patients with identified risk factors for liver disease were excluded from study. All patients underwent ultrasound scan of liver. Results There were 118 participants with ACS. The number of patients with NAFLD was 55 (46.6%) and patients without NAFLD was 63 (53.4%). The number of male patients with NAFLD was 31 (56.4%) versus 40 (63.5%) in patients without NAFLD. There was a significant increase in total Global Registry of Acute Coronary Events score in patients with NAFLD versus patients without NAFLD and also patients with NAFLD showed significant increased high and intermediate risk of death during the hospital stay versus patients without NAFLD. Conclusion Patients with NAFLD and ACS require aggressive treatment of CAD and higher predicted mortality.

Anti-cyclic citrullinated peptide antibodies in ulcerative colitis with and without joint involvement Tarek A Fouad, El Saied E Shabaan, Mohamed A Safy, Aisha El-Shimy, Hala I Mohamed, Wael Gomah Journal of Medicine in Scientific Research 2018 1(4):234-238 Background Joint affection is the most common extraintestinal manifestation of ulcerative colitis (UC). Despite the high specificity of anti-cyclic citrullinated peptide (CCP) antibodies for rheumatoid arthritis, their role in UC remains unclear. Aim The aims of this study were to assess the prevalence of anti-CCP antibodies in patients with UC and to investigate any association with joint affection. Patients and methods A total of 60 patients with UC were studied. Demographic data were collected, careful history was taken, and clinical examination including rheumatologic examination was done. A blood sample was collected for assessment of anti-CCP and other laboratory tests. Colonoscopy was done for assessment of severity and extension of UC. Results Joint affection was found in 28.33% of patients. Anti-CCP antibody was positive in 8.33% of patients. There were no statistically significant differences between patients with positive and negative anti-CCP antibody regarding joint affection or UC activity or extension. Conclusion The prevalence of anti-CCP antibodies in patients with UC was 8.33%, but there was no association between the presence of these antibodies and the joint affection or disease activity or extension.

Effects of iron-deficiency anemia on auditory function in school-aged children Gehan M S. Abd El-Salam, Eman Soliman Abd El-Gaffar, Hala M Abd El-Samad Journal of Medicine in Scientific Research 2018 1(4):239-244 Introduction Iron is important for proper myelination of spinal cord and white matter of cerebellar folds in brain and is a cofactor for a number of enzymes involved in neurotransmitter synthesis. Auditory brainstem evoked response (ABR) represents the progressive activation of different levels of the auditory pathway from the acoustic nerve (wave I) to the lateral lemniscuses (wave V). Otoacoustic emissions (OAEs) are sounds measured in the external ear canal that reflect movement of the outer hair cells in the cochlea. Patients and methods A total of 40 children, of both sexes, with age ranging from 6–12 years old, were selected for this study after a thorough clinical assessment to exclude any other pathological disorder other than anemia. They are compared with a control group that consisted of 20 normal children of the same age. After laboratory investigations, all children were examined by ABR and transient-evoked OAEs. The study group children were classified according to ABR results into study group 1, comprising anemic children with abnormal ABR results and study group 2, comprising anemic children with normal ABR results. Results ABR showed that absolute peak latencies of waves I, III, and V and interpeak latencies were prolonged; moreover, ABR waves I and V showed reduced amplitude in study group 1 than control group, and the difference is statistically significant. In contrast, there was no statistically significant difference between study group 2 and control group regarding ABR results. Transient-evoked OAEs results showed no statistically significant difference between anemic children and control group. Conclusion This study added to the evidences that iron-deficiency anemia is a risk factor for auditory function impairment. Further studies for the effect of timing, duration, and severity of iron deficiency on auditory functions are needed. Well-designed large-scale studies are needed to address the iron-deficiency anemia in health planning programs to put plans for control and prevention especially in developing countries.

The relationship between presbycusis and vestibular activity Gehan M S. Abd El-Salam Journal of Medicine in Scientific Research 2018 1(4):245-249 Introduction Presbycusis or age-related sensorineural hearing loss (SNHL) is a complex disorder that results in a slow deterioration in auditory function. A considerably high number of these patients with presbycusis or age-related SNHL also experience dizziness and related vestibular symptoms. Although auditory and vestibular systems are distinct, they work just alike. So, there is a great relation among their functions. Once one is stimulated, the other experiences changes as well. Participants and methods This study comprised 40 adult patients (50–75 years) without any vestibular symptoms or diagnosed vestibular diseases. Audiological status was measured with auditory brainstem response (ABR). The vestibular system was assessed using videonystagmography test battery, sensory organization test, and vestibular evoked myogenic potential (VEMP). ‘Get up and go’ test was used as a quick screening tool for detecting balance problems. Patients were divided into two groups: a study group (patients with SNHL) and a control group (patients without SNHL). ABR and VEMP results of the groups were calculated and compared. Results Absolute peak latencies of ABR waves I, III, and V were prolonged in the study group than the control group (P < 0.0001). VEMP results showed that P13 and N23 latencies were prolonged in the study group when compared with the control group (P < 0.0001). Conclusion Thorough full examination of the vestibular system, in conjunction with auditory functions in elderly persons, is recommended. This may help to discover their subclinical vestibular problem and guide physicians to design a suitable treatment plan that helps in decreasing risk of falls for aged persons.

Effect of pulsed electromagnetic field on menstrual distress in primary dysmenorrhic women Ahmed H Abd El Aziz, Engy M El Nahas, Hesham M Kamal Journal of Medicine in Scientific Research 2018 1(4):250-254 Background Primary dysmenorrhea is a common menstrual cramp that is recurrent and is not owing to other diseases and is a common cause of stay at home and school or work. Purpose The purpose of this study was to investigate the effect of pulsed electromagnetic field (PEMF) on menstrual distress in primary dysmenorrheic women. Patients and methods A total of 40 women having primary dysmenorrhea were selected from Physical Therapy Department in Al Mataria Teaching Hospital in Cairo. Their ages ranged from 20 to 30 years. They were divided randomly into two groups equal in number: group A (study group), treated with the PEMF, three times/week for 3 months, with each session lasted for 30 min, in addition to medical treatment, and group B (control group, which received medical treatment only (NSAIDs). Menstrual distress questionnaire and visual analog scale were used for assessment of menstrual distress and pain before treatment and after treatment for both groups A and B. Results The results showed that there is a significant improvement in menstrual distress and pain scores in both groups A and B after treatment, in favor of group A. Conclusion It was concluded that PEMF is effective in improving dysmenorrheic pain and menstrual distress score.

Prevalence of allergic disorders of respiratory system in children in Shebin Elkom Khaled ElKelany, Salama ElShenawy, Ezzat Rizk, Mohamed F Al Soda Journal of Medicine in Scientific Research 2018 1(4):255-260 Introduction Allergic rhinitis is a global health problem that causes significant illness and disability worldwide. Interactions between the lower and the upper airways are well known and have been studied since 1990. More than 80% of asthmatics have rhinitis, and 10–40% of patients with rhinitis have asthma. Indoor and outdoor allergens, as well as occupational agents, cause rhinitis and other allergic diseases. Aim A trial was done to determine or distinguish the causative agents, either one or multiple agents, in allergic patients. We hope this will help us in the management of allergic patients by avoiding this causative agent(s) if possible. Patients and methods A total of 97 individuals were recruited from the outpatient clinics of Shebin Elkom teaching hospital. Results Pigeon and pollens showed the highest prevalence at 56.7%, whereas wheat showed the least incidence at 5.15%. As for ingestant, the cacao showed the highest incidence at 16.49%, and the least one was strawberry at 5.15%. Conclusion The importance of our research that If we recognize the causative allergen that triggers the allergic disorder, we can try to avoid it and protect the patient from the hazards of an allergic disorder.

Screening and identification of red blood cell alloantibodies among hemodialysis patients in National Institute of Urology and Nephrology Aisha M A. Elshimy, Tarek A Fouad, Ahmed Hasan Journal of Medicine in Scientific Research 2018 1(4):261-265 Background It is well known that alloimmunization to red blood cell antigens resulting from the genetic disparities between the donor and the recipient is one of the risks of blood transfusion. Alloimmunization can result in clinical hemolysis and difficulty in cross-matching blood. The risk of alloimmunization is higher in patients who have received multiple blood transfusions such as renal failure patients on dialysis who receive blood transfusions. The antibody-screening test (2–3 cells panel) used to detect unexpected antibodies is not a mandatory pretransfusion testing in our blood bank of National Institute of Urology and Nephrology (NIUN), and is performed routinely in limited blood centers. Aim This study was conducted to screen and identify different types of red cell alloantibodies and the factors influencing the development of alloantibodies among patients on dialysis in NIUN. Patients and methods This study was conducted in the blood bank of NIUN, Egypt. A total of 192 patients (102 males and 90 women) who were diagnosed to have chronic renal failure, on regular hemodialysis for at least 1 year, their age more than 20 years, anemic (hemoglobin <8 g/dl), and with a previous history of blood transfusion for at least once were selected for the study. All patients’ sera were subjected to the following tests: antibody screening, patients’ sera were tested against three panels of commercially prepared group O cells and antibody identification, positive patients’ sera by a screening test, and retested against commercial panels of 11 cells. Results Red cell alloantibodies were detected in 10 (5.2%) patients (two men and eight women). The prevalence of alloantibodies detected in patients with positive results were anti-E (2.1%), anti-K (1.6%), antibodies of unknown specificity (1.6%), and antibody against high-incidence antigen (0.5%). There was a significant difference between sex and the number of blood units transfused with alloimmunization (P = 0.048 and 0.037, respectively). Conclusion The prevalence of alloimmunization among chronic renal failure patients on dialysis was 5.2%. The most common alloantibodies were anti-E (the Rhesus system) (2.1%) and anti-K (the Kell system) (1.6%) and the risk of alloimmunization is known to be influenced by the recipient sex (more in females) as well as the number of blood units transfused. So, antibody screening and identification tests are recommended as a routine pretransfusion testing protocol at least for the patients who are at higher risk of alloimmunization and require long-term transfusion dependence, which will definitely add significant value in blood safety.

Association of matrix metalloproteinase-9 and tissue inhibitor of metalloproteinase-1 levels with diabetic foot ulcer in Egyptians with type 2 diabetes mellitus Ghada H Sayed, Ghada A Omar, Ayat I Ghanem, Naglaa F Mohamed, Mourad I El-Kholy Journal of Medicine in Scientific Research 2018 1(4):266-270 Background The imbalance between matrix metalloproteinase-9 (MMP-9) and tissue inhibitor of metalloproteinase-1 (TIMP-1) may play an important role in impaired healing of diabetic foot ulcer. Aim of the work This study was designed to investigate the association of MMP-9 and TIMP-1 levels in diabetic foot ulcer among Egyptian patients with type 2 diabetes mellitus attending the outpatient clinic of National institute of diabetes and endocrinology. Patients and methods This study was conducted on a total number of 90 participants comprising three groups: group I included 35 type 2 diabetic patients without foot ulcer. Group II included 35 type 2 diabetic patients having various degrees of foot ulcer complications. Group III included 20 apparently healthy participants (as controls). In addition to the routine clinical and laboratory investigations, MMP-9 and TIMP-1 were measured. All patients were randomly taken from the outpatient clinic of National institute of diabetes and endocrinology. Results The study results showed that the higher levels of plasma MMP-9 and the lower levels of TIMP-1 were associated with patients with diabetic foot ulcer. Conclusion The measurement of plasma MMP-9 and TIMP-1 in type 2 diabetic patients may help us to know the patients at most risk to develop diabetic foot ulcer.