Search results for: multicenter
Commenced in January 2007
Frequency: Monthly
Edition: International
Paper Count: 28

Search results for: multicenter

28 A Novel Method For Non-Invasive Diagnosis Of Hepatitis C Virus Using Electromagnetic Signal Detection: A Multicenter International Study

Authors: Gamal Shiha, Waleed Samir, Zahid Azam, Premashis Kar, Saeed Hamid, Shiv Sarin

Abstract:

A simple, rapid and non-invasive electromagnetic sensor (C-FAST device) was- patented; for diagnosis of HCV RNA. Aim: To test the validity of the device compared to standard HCV PCR. Subjects and Methods: The first phase was done as pilot in Egypt on 79 participants; the second phase was done in five centers: one center from Egypt, two centers from Pakistan and two centers from India (800, 92 and 113 subjects respectively). The third phase was done nationally as multicenter study on (1600) participants for ensuring its representativeness. Results: When compared to PCR technique, C-FAST device revealed sensitivity 95% to 100%, specificity 95.5% to 100%, PPV 89.5% to 100%, NPV 95% to 100% and positive likelihood ratios 21.8% to 38.5%. Conclusion: It is practical evidence that HCV nucleotides emit electromagnetic signals that can be used for its identification. As compared to PCR, C-FAST is an accurate, valid and non-invasive device.

Keywords: C-FAST- a valid and reliable device, distant cellular interaction, electromagnetic signal detection, non-invasive diagnosis of HCV

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27 Reliable Soup: Reliable-Driven Model Weight Fusion on Ultrasound Imaging Classification

Authors: Shuge Lei, Haonan Hu, Dasheng Sun, Huabin Zhang, Kehong Yuan, Jian Dai, Yan Tong

Abstract:

It remains challenging to measure reliability from classification results from different machine learning models. This paper proposes a reliable soup optimization algorithm based on the model weight fusion algorithm Model Soup, aiming to improve reliability by using dual-channel reliability as the objective function to fuse a series of weights in the breast ultrasound classification models. Experimental results on breast ultrasound clinical datasets demonstrate that reliable soup significantly enhances the reliability of breast ultrasound image classification tasks. The effectiveness of the proposed approach was verified via multicenter trials. The results from five centers indicate that the reliability optimization algorithm can enhance the reliability of the breast ultrasound image classification model and exhibit low multicenter correlation.

Keywords: breast ultrasound image classification, feature attribution, reliability assessment, reliability optimization

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26 Drug-related Problems and Associated Factors among Adult Psychiatric Inpatients in Northwest Ethiopia: Multicenter Cross-Sectional Study

Authors: Ephrem Mebratu Dagnew, Mohammed Biset Ayalew, Gizework Alemnew Mekonnen, Alehegn Bishaw Geremew, Ousman Abubeker Abdela

Abstract:

Objective: To assess the prevalence of drug-related problems and associated factors among adult psychiatric inpatients. Method: Hospital-based multicenter cross-sectional observational study was conducted from April to July 2021 at five randomly selected hospitals in North-west Ethiopia. A total of 325 consecutively sampled patients participated in the study. Clinical pharmacists assessed the DRPs based on clinical judgment supported by updated evidence-based diseases guidelines. A Medscape drug-interactions checker was used to check drug-drug interactions. The results were summarized using descriptive statistics, including frequency, mean, and standard deviation. Odds ratio (OR) with 95% confidence interval were also computed for each variable for the corresponding P-value. The value of P ≤ 0.05 was considered statistically significant. Result : From the total of 325 study participants, more than half of them (52.9%) were females and the mean age ± (standard deviation) was 30.8±11.3 years. At least one drug-related problem was recorded from 60.9%, 95% CI (55.7-65.8) of study participants with a mean of 0.6±0.49 per patient. Need additional drug therapy was the most common DRP (22.8%), followed by non-adherence to medicine (20.6%) and adverse drug reactions (11%), respectively. Factors independently associated with drug-related problems were rural residence [AOR=1.96,95%CI:1.01-2.84, P-value=0.046], self-employed [AOR=6.0 ,95% CI: 1.0-36.9, P-value=0.035] and alcohol drinkers [AOR=6.40,95%CI:1.12-37.5, p-value=0.034]. Conclusion: The prevalence of drug-related problems among adult psychiatric patients admitted to psychiatric wards was high. Healthcare providers give more attention to tackling these problems. Being a rural residence, self-employed, and Alcohol drinkers were associated with drug-related problems.

Keywords: psychiatric patients, drug-relatedproblems, multicenter, Ethiopia

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25 A Multicenter Assessment on Psychological Well-Being Status among Medical Residents in the United Arab Emirates

Authors: Mahera Abdulrahman

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Objective: Healthcare transformation from traditional to modern in the country recently prompted the need to address career choices, accreditation perception and satisfaction among medical residents. However, a concerted nationwide study to understand and address burnout in the medical residency program has not been conducted in the UAE and the region. Methods: A nationwide, multicenter, cross-sectional study was designed to evaluate professional burnout and depression among medical residents in order to address the gap. Results: Our results indicate that 75.5% (216/286) of UAE medical residents had moderate to high emotional exhaustion, 84% (249/298) had high depersonalization, and 74% (216/291) had a low sense of personal accomplishment. In aggregate, 70% (212/302) of medical residents were considered to be experiencing at least one symptom of burnout based on a high emotional exhaustion score or a high depersonalization score. Depression ranging from 6-22%, depending on the specialty was also striking given the fact the Arab culture lays high emphasis on family bonding. Interestingly 83% (40/48) of medical residents who had high scores for depression also reported burnout. Conclusion: Our data indicate that burnout and depression among medical residents is epidemic. There is an immediate need to address burnout through effective interventions at both the individual and institutional levels. It is imperative to reconfigure the approach to medical training for the well-being of the next generation of physicians in the Arab world.

Keywords: mental health, Gulf, Arab, residency training, burnout, depression

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24 Medication Errors in Neonatal Intensive Care Unit

Authors: Ramzi Shawahna

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Background: Neonatal intensive care units are high-risk settings where medication errors can occur and cause harm to this fragile segment of patients. This multicenter qualitative study was conducted to describe medication errors that occurred in neonatal intensive care units in Palestine from the perspectives of healthcare providers. Methods: This exploratory multicenter qualitative study was conducted and reported in adherence to the consolidated criteria for reporting qualitative research checklist. Semi-structured in-depth interviews were conducted with healthcare professionals (4 pediatricians/neonatologists and 11 intensive care unit nurses) who provided care services for patients admitted to neonatal intensive care units in Palestine. An interview schedule guided the semi-structured in-depth interviews. The qualitative interpretive description approach was used to thematically analyze the data. Results: The total duration of the interviews was 282 min. The healthcare providers described their experiences with 41 different medication errors. These medication errors were categorized under 3 categories and 10 subcategories. Errors that occurred while preparing/diluting/storing medications were related to calculations, using a wrong solvent/diluent, dilution errors, failure to adhere to guidelines while preparing the medication, failure to adhere to storage/packaging guidelines, and failure to adhere to labeling guidelines. Errors that occurred while prescribing/administering medications were related to inappropriate medication for the neonate, using a different administration technique from the one that was intended and administering a different dose from the one that was intended. Errors that occurred after administering the medications were related to failure to adhere to monitoring guidelines. Conclusion: In this multicenter study, pediatricians/neonatologists and neonatal intensive care unit nurses described medication errors occurring in intensive care units in Palestine. Medication errors occur in different stages of the medication process: preparation/dilution/storage, prescription/administration, and monitoring. Further studies are still needed to quantify medication errors occurring in neonatal intensive care units and investigate if the designed strategies could be effective in minimizing medication errors.

Keywords: medication errors, pharmacist, pharmacology, neonates

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23 Complications and Outcomes of Cochlear Implantation in Children Younger than 12 Months: A Multicenter Study

Authors: Alimohamad Asghari, Ahmad Daneshi, Mohammad Farhadi, Arash Bayat, Mohammad Ajalloueyan, Marjan Mirsalehi, Mohsen Rajati, Seyed Basir Hashemi, Nader Saki, Ali Omidvari

Abstract:

Evidence suggests that Cochlear Implantation (CI) is a beneficial approach for auditory and speech skills improvement in children with severe to profound hearing loss. However, it remains controversial if implantation in children <12 months is safe and effective compared to older children. The present study aimed to determine whether children's ages affect surgical complications and auditory and speech development. The current multicenter study enrolled 86 children who underwent CI surgery at <12 months of age (group A) and 362 children who underwent implantation between 12 and 24 months of age (group B). The Categories of Auditory Performance (CAP) and Speech Intelligibility Rating (SIR) scores were determined pre-impanation, and "one-year" and "two-year" post-implantation. Four complications (overall rate: 4.65%; three minor) occurred in group A and 12 complications (overall rate: 4.41%; nine minor) occurred in group B. We found no statistically significant difference in the complication rates between the groups (p>0.05). The mean SIR and CAP scores improved over time following CI activation in both groups. However, we did not find significant differences in CAP and SIR scores between the groups across different time points. Cochlear implantation is a safe and efficient procedure in children younger than 12 months, providing substantial auditory and speech benefits comparable to children undergoing implantation at 12 to 24 months of age. Furthermore, surgical complications in younger children are similar to those of children undergoing the CI at an older age.

Keywords: cochlear implant, Infant, complications, outcome

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22 More Precise: Patient-Reported Outcomes after Stroke

Authors: Amber Elyse Corrigan, Alexander Smith, Anna Pennington, Ben Carter, Jonathan Hewitt

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Background and Purpose: Morbidity secondary to stroke is highly heterogeneous, but it is important to both patients and clinicians in post-stroke management and adjustment to life after stroke. The consideration of post-stroke morbidity clinically and from the patient perspective has been poorly measured. The patient-reported outcome measures (PROs) in morbidity assessment help improve this knowledge gap. The primary aim of this study was to consider the association between PRO outcomes and stroke predictors. Methods: A multicenter prospective cohort study assessed 549 stroke patients at 19 hospital sites across England and Wales during 2019. Following a stroke event, demographic, clinical, and PRO measures were collected. Prevalence of morbidity within PRO measures was calculated with associated 95% confidence intervals. Predictors of domain outcome were calculated using a multilevel generalized linear model. Associated P -values and 95% confidence intervals are reported. Results: Data were collected from 549 participants, 317 men (57.7%) and 232 women (42.3%) with ages ranging from 25 to 97 (mean 72.7). PRO morbidity was high post-stroke; 93.2% of the cohort report post-stroke PRO morbidity. Previous stroke, diabetes, and gender are associated with worse patient-reported outcomes across both the physical and cognitive domains. Conclusions: This large-scale multicenter cohort study illustrates the high proportion of morbidity in PRO measures. Further, we demonstrate key predictors of adverse outcomes (Diabetes, previous stroke, and gender) congruence with clinical predictors. The PRO has been demonstrated to be an informative and useful stroke when considering patient-reported outcomes and has wider implications for considerations of PROs in clinical management. Future longitudinal follow-up with PROs is needed to consider association of long-term morbidity.

Keywords: morbidity, patient-reported outcome, PRO, stroke

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21 Dorsal Root Ganglion Neuromodulation as an Alternative to Opioids in the Evolving Healthcare Crisis

Authors: Adam J. Carinci

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Background: The opioid epidemic is the most pressing healthcare crisis of our time. There is increasing recognition that opioids have limited long-term efficacy and are associated with hyperalgesia, addiction, and increased morbidity and mortality. Therefore, alternative strategies to combat chronic pain are paramount. We initiated a multicenter retrospective case series to review the efficacy of DRG stimulation in facilitating opioid tapering, opioid discontinuation and as a viable alternative to chronic opioid therapy. Purpose: The dorsal root ganglion (DRG) plays a key role in the development and maintenance of pain. Recent innovations in neuromodulation, specifically, dorsal root ganglion stimulation, offers an effective alternative to opioids in the treatment of chronic pain. This retrospective case series demonstrates preliminary evidence that DRG stimulation facilitates opioid tapering, opioid discontinuation and presents a viable alternative to chronic opioid therapy. Procedure: This small multicenter retrospective case series provides preliminary evidence that DRG stimulation facilitates opioid weaning, opioid tapering and is a viable option to opioid therapy in the treatment of chronic pain. A retrospective analysis was completed. Visual analog scale pain scores and pain medication usage were collected at the baseline visit and after four weeks, 3 months and 6 months of treatment. Ten consecutive patients across two study centers were included. The pain was rated 7.38 at baseline and decreased to 1.50 at the 4-week follow-up, a reduction of 79.5%. All patients significantly decreased their opioid pain medication use with an average > 30% reduction in morphine equivalents and four were able to discontinue their medications entirely. Conclusion: This Retrospective case series demonstrates preliminary evidence that DRG stimulation facilitates opioid tapering, opioid discontinuation and presents a viable alternative to chronic opioid therapy.

Keywords: dorsal root ganglion, neuromodulation, opioid sparing, stimulation

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20 Multicenter Baseline Survey to Outline Antimicrobial Prescribing Practices at Six Public Sectortertiary Care Hospitals in a Low Middle Income Country

Authors: N. Khursheed, M. Fatima, S. Jamal, A. Raza, S. Rattani, Q. Ahsan, A. Rasheed, M. Jawed

Abstract:

Introduction: Antibiotics are among the commonly prescribed medicines to treat bacterial infections. Their misuse intensifies resistance, and overuse incurs heavy losses to the healthcare system in terms of increased treatment costs and enhanced disease burden. Studies show that 40% of empirically used antibiotics are irrationally utilized. The objective of this study was to evaluate prescribing pattern of antibiotics at six public sector tertiary care hospitals across Pakistan. Methods: A multicenter cross-sectional point prevalence survey (PPS) was conducted in selected wards of six public sector tertiary care hospitals in Pakistan as part of the Clinical Engagement program by Fleming Fund Country Grant Pakistan in collaboration with Indus Hospital & Health Network (IHHN) from February to March 2021, these included Jinnah Postgraduate Medical Center and Dr. Ruth K. M. Pfau Civil Hospital from Karachi, Sheikh Zayed Hospital Lahore, Nishtar Medical University Hospital Multan, Medical Teaching Institute Hayatabad Medical Complex Peshawar, and Provincial Headquarters Hospital Gilgit. WHO PPS methodology was used for data collection (Hospital, ward, and patient level data was collected). Data was entered into the open-source Kobo Collect application and was analyzed using SPSS (version 22.0). Findings: Medical records of 837 in-patients were surveyed, of which the prevalence of antibiotics use was 78.5%. The most commonly prescribed antimicrobial was Ceftriaxone (21.7%) which is categorized in the Watch group of WHO AWaRe Classification, followed by Metronidazole (17.3%), Cefoperazone/Sulbactam (8.4%), Co-Amoxiclav (6.3%) and Piperacillin/Tazobactam (5.9%). The antibiotics were prescribed largely for surgical prophylaxis (36.7%), followed by community-acquired infections (24.7%). One antibiotic was prescribed to 46.7%, two to 39.9%, and three or more to 12.5 %. Two of six (30%) hospitals had functional drug and therapeutic committees, three (50%) had infection prevention and control committees, and one facility had an antibiotic formulary. Conclusion: Findings demonstrate high consumption of broad-spectrum antimicrobials and emphasizes the importance of expanding the antimicrobial stewardship program. Mentoring clinical teams will help to rationalize antimicrobial use.

Keywords: antimicrobial resistance, antimicrobial stewardship, point prevalence survey, antibiotics

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19 Clinical Correlates of Suicide Attempts in Trauma-Exposed Youth

Authors: Sandra Landy

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Traumatic experiences in youth are a major risk factor for future suicidality. With suicide steadily increasing over the last 20 years as one of the top three leading causes of death in children and adolescents, it is essential to examine the aspects of trauma that contribute to suicidality. A quantitative secondary data analysis of a prospective, multicenter 24-month observational study of youth who have experienced traumatic experiences was utilized to determine the relationship between bullying and suicide attempts, cyberbullying and suicide attempts, and number of traumas and suicide attempts. Data was analyzed with the Spearman-rank correlation test to determine the relationships. Findings supported past research establishing a relationship between bulling, including cyberbullying, and suicide attempts, as well as increasing number of traumatic experiences and suicide attempts. Further large scale studies may be beneficial to support these findings.

Keywords: adolescent(s), suicide, trauma, bullying, cyberbullying

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18 Multicenter Evaluation of the ACCESS HBsAg and ACCESS HBsAg Confirmatory Assays on the DxI 9000 ACCESS Immunoassay Analyzer, for the Detection of Hepatitis B Surface Antigen

Authors: Vanessa Roulet, Marc Turini, Juliane Hey, Stéphanie Bord-Romeu, Emilie Bonzom, Mahmoud Badawi, Mohammed-Amine Chakir, Valérie Simon, Vanessa Viotti, Jérémie Gautier, Françoise Le Boulaire, Catherine Coignard, Claire Vincent, Sandrine Greaume, Isabelle Voisin

Abstract:

Background: Beckman Coulter, Inc. has recently developed fully automated assays for the detection of HBsAg on a new immunoassay platform. The objective of this European multicenter study was to evaluate the performance of the ACCESS HBsAg and ACCESS HBsAg Confirmatory assays† on the recently CE-marked DxI 9000 ACCESS Immunoassay Analyzer. Methods: The clinical specificity of the ACCESS HBsAg and HBsAg Confirmatory assays was determined using HBsAg-negative samples from blood donors and hospitalized patients. The clinical sensitivity was determined using presumed HBsAg-positive samples. Sample HBsAg status was determined using a CE-marked HBsAg assay (Abbott ARCHITECT HBsAg Qualitative II, Roche Elecsys HBsAg II, or Abbott PRISM HBsAg assay) and a CE-marked HBsAg confirmatory assay (Abbott ARCHITECT HBsAg Qualitative II Confirmatory or Abbott PRISM HBsAg Confirmatory assay) according to manufacturer package inserts and pre-determined testing algorithms. False initial reactive rate was determined on fresh hospitalized patient samples. The sensitivity for the early detection of HBV infection was assessed internally on thirty (30) seroconversion panels. Results: Clinical specificity was 99.95% (95% CI, 99.86 – 99.99%) on 6047 blood donors and 99.71% (95%CI, 99.15 – 99.94%) on 1023 hospitalized patient samples. A total of six (6) samples were found false positive with the ACCESS HBsAg assay. None were confirmed for the presence of HBsAg with the ACCESS HBsAg Confirmatory assay. Clinical sensitivity on 455 HBsAg-positive samples was 100.00% (95% CI, 99.19 – 100.00%) for the ACCESS HBsAg assay alone and for the ACCESS HBsAg Confirmatory assay. The false initial reactive rate on 821 fresh hospitalized patient samples was 0.24% (95% CI, 0.03 – 0.87%). Results obtained on 30 seroconversion panels demonstrated that the ACCESS HBsAg assay had equivalent sensitivity performances compared to the Abbott ARCHITECT HBsAg Qualitative II assay with an average bleed difference since first reactive bleed of 0.13. All bleeds found reactive in ACCESS HBsAg assay were confirmed in ACCESS HBsAg Confirmatory assay. Conclusion: The newly developed ACCESS HBsAg and ACCESS HBsAg Confirmatory assays from Beckman Coulter have demonstrated high clinical sensitivity and specificity, equivalent to currently marketed HBsAg assays, as well as a low false initial reactive rate. †Pending achievement of CE compliance; not yet available for in vitro diagnostic use. 2023-11317 Beckman Coulter and the Beckman Coulter product and service marks mentioned herein are trademarks or registered trademarks of Beckman Coulter, Inc. in the United States and other countries. All other trademarks are the property of their respective owners.

Keywords: dxi 9000 access immunoassay analyzer, hbsag, hbv, hepatitis b surface antigen, hepatitis b virus, immunoassay

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17 Multicenter Evaluation of the ACCESS Anti-HCV Assay on the DxI 9000 ACCESS Immunoassay Analyzer, for the Detection of Hepatitis C Virus Antibody

Authors: Dan W. Rhodes, Juliane Hey, Magali Karagueuzian, Florianne Martinez, Yael Sandowski, Vanessa Roulet, Mahmoud Badawi, Mohammed-Amine Chakir, Valérie Simon, Jérémie Gautier, Françoise Le Boulaire, Catherine Coignard, Claire Vincent, Sandrine Greaume, Isabelle Voisin

Abstract:

Background: Beckman Coulter, Inc. (BEC) has recently developed a fully automated second-generation anti-HCV test on a new immunoassay platform. The objective of this multicenter study conducted in Europe was to evaluate the performance of the ACCESS anti-HCV assay on the recently CE-marked DxI 9000 ACCESS Immunoassay Analyzer as an aid in the diagnosis of HCV (Hepatitis C Virus) infection and as a screening test for blood and plasma donors. Methods: The clinical specificity of the ACCESS anti-HCV assay was determined using HCV antibody-negative samples from blood donors and hospitalized patients. Sample antibody status was determined by a CE-marked anti-HCV assay (Abbott ARCHITECTTM anti-HCV assay or Abbott PRISM HCV assay) with an additional confirmation method (Immunoblot testing with INNO-LIATM HCV Score - Fujirebio), if necessary, according to pre-determined testing algorithms. The clinical sensitivity was determined using known HCV antibody-positive samples, identified positive by Immunoblot testing with INNO-LIATM HCV Score - Fujirebio. HCV RNA PCR or genotyping was available on all Immunoblot positive samples for further characterization. The false initial reactive rate was determined on fresh samples from blood donors and hospitalized patients. Thirty (30) commercially available seroconversion panels were tested to assess the sensitivity for early detection of HCV infection. The study was conducted from November 2019 to March 2022. Three (3) external sites and one (1) internal site participated. Results: Clinical specificity (95% CI) was 99.7% (99.6 – 99.8%) on 5852 blood donors and 99.0% (98.4 – 99.4%) on 1527 hospitalized patient samples. There were 15 discrepant samples (positive on ACCESS anti-HCV assay and negative on both ARCHITECT and Immunoblot) observed with hospitalized patient samples, and of note, additional HCV RNA PCR results showed five (5) samples had positive HCV RNA PCR results despite the absence of HCV antibody detection by ARCHITECT and Immunoblot, suggesting a better sensitivity of the ACCESS anti-HCV assay with these five samples compared to the ARCHITECT and Immunoblot anti-HCV assays. Clinical sensitivity (95% CI) on 510 well-characterized, known HCV antibody-positive samples was 100.0% (99.3 – 100.0%), including 353 samples with known HCV genotypes (1 to 6). The overall false initial reactive rate (95% CI) on 6630 patient samples was 0.02% (0.00 – 0.09%). Results obtained on 30 seroconversion panels demonstrated that the ACCESS anti-HCV assay had equivalent sensitivity performances, with an average bleed difference since the first reactive bleed below one (1), compared to the ARCHITECTTM anti-HCV assay. Conclusion: The newly developed ACCESS anti-HCV assay from BEC for use on the DxI 9000 ACCESS Immunoassay Analyzer demonstrated high clinical sensitivity and specificity, equivalent to currently marketed anti-HCV assays, as well as a low false initial reactive rate.

Keywords: DxI 9000 ACCESS Immunoassay Analyzer, HCV, HCV antibody, Hepatitis C virus, immunoassay

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16 Relationship Between Pain Intensity at the Time of the Hamstring Muscle Injury and Hamstring Muscle Lesion Volume Measured by Magnetic Resonance Imaging

Authors: Grange Sylvain, Plancher Ronan, Reurink Guustav, Croisille Pierre, Edouard Pascal

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The primary objective of this study was to analyze the potential correlation between the pain experienced at the time of a hamstring muscle injury and the volume of the lesion measured on MRI. The secondary objectives were to analyze a correlation between this pain and the lesion grade as well as the affected hamstring muscle. We performed a retrospective analysis of the data collected in a prospective, multicenter, non-interventional cohort study (HAMMER). Patients with suspected hamstring muscle injury had an MRI after the injury and at the same time were evaluated for their pain intensity experienced at the time of the injury with a Numerical Pain Rating Scale (NPRS) from 0 to 10. A total of 61 patients were included in the present analysis. MRIs were performed in an average of less than 8 days. There was a significant correlation between pain and the injury volume (r=0.287; p=0.025). There was no significant correlation between the pain and the lesion grade (p>0.05), nor between the pain and affected hamstring muscle (p>0.05). Pain at the time of injury appeared to be correlated with the volume of muscle affected. These results confirm the value of a clinical approach in the initial evaluation of hamstring injuries to better select patients eligible for further imaging.

Keywords: hamstring muscle injury, MRI, volume lesion, pain

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15 Characteristics of Acute Poisoning in Emergency Departments: Multicenter Study in Korea

Authors: Hyuk-Hoon Kim, Young Gi Min

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Background: Acute poisoning is the common cause of morbidity and mortality. Characteristics of acute poisoning differ between countries. While other countries operate the database system for poisoning, Korea has not collected the database for acute poisoning. Distribution of incidence of acute poisoning depending on the types of materials have also not studied in Korea. Our aims are to evaluate the etiologic and demographic characteristics of acute poisoning cases and to obtain up-to-date information on acute poisonings. Method: We retrospectively recorded cases of acute poisoning from eight emergency departments of second level or university hospitals from different cities in Gyeonggi province in Korea from April 2006 and March 2015. The distributions of incidence of acute poisoning depending on the types of materials are mapped by geographic information system. Result: A total of 3,449 poisoned cases were analyzed. Mean estimated age of patients was 39.56 ± 22.40 years. Mean male to female ratio of patients was 1:1.4. Mean proportion of intentional poisoning was 57.9%. Common materials are benzodiazepine (16.6%), carbon monoxide (10.5%), pesticide (8.1%) and zolpidem (7.1%) Common route of exposure is ingestion (79.5%) and followed by inhalation (16.5%). Common treatment methods are gastric lavage (20%) and activated charcoal (30%). Most cases had uneventful recovery; 61.4% were treated as outpatients and 0.1% of the poisoning resulted in death in ER. Conclusion: Even though the cases enrolled in our study is not the overall cases of acute poisoning in Korea, our study could be the basis of countermeasures for analysis and prevention of acute poisoning in Korea.

Keywords: acute poisoning, emergency department, epidemiology, Korea

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14 Diagnostic Accuracy of the Tuberculin Skin Test for Tuberculosis Diagnosis: Interest of Using ROC Curve and Fagan’s Nomogram

Authors: Nouira Mariem, Ben Rayana Hazem, Ennigrou Samir

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Background and aim: During the past decade, the frequency of extrapulmonary forms of tuberculosis has increased. These forms are under-diagnosed using conventional tests. The aim of this study was to evaluate the performance of the Tuberculin Skin Test (TST) for the diagnosis of tuberculosis, using the ROC curve and Fagan’s Nomogram methodology. Methods: This was a case-control, multicenter study in 11 anti-tuberculosis centers in Tunisia, during the period from June to November2014. The cases were adults aged between 18 and 55 years with confirmed tuberculosis. Controls were free from tuberculosis. A data collection sheet was filled out and a TST was performed for each participant. Diagnostic accuracy measures of TST were estimated using ROC curve and Area Under Curve to estimate sensitivity and specificity of a determined cut-off point. Fagan’s nomogram was used to estimate its predictive values. Results: Overall, 1053 patients were enrolled, composed of 339 cases (sex-ratio (M/F)=0.87) and 714 controls (sex-ratio (M/F)=0.99). The mean age was 38.3±11.8 years for cases and 33.6±11 years for controls. The mean diameter of the TST induration was significantly higher among cases than controls (13.7mm vs.6.2mm;p=10-6). Area Under Curve was 0.789 [95% CI: 0.758-0.819; p=0.01], corresponding to a moderate discriminating power for this test. The most discriminative cut-off value of the TST, which were associated with the best sensitivity (73.7%) and specificity (76.6%) couple was about 11 mm with a Youden index of 0.503. Positive and Negative predictive values were 3.11% and 99.52%, respectively. Conclusion: In view of these results, we can conclude that the TST can be used for tuberculosis diagnosis with a good sensitivity and specificity. However, the skin induration measurement and its interpretation is operator dependent and remains difficult and subjective. The combination of the TST with another test such as the Quantiferon test would be a good alternative.

Keywords: tuberculosis, tuberculin skin test, ROC curve, cut-off

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13 Embolization of Spinal Dural Arteriovenous Fistulae: Clinical Outcomes and Long-Term Follow-Up: A Multicenter Study

Authors: Walid Abouzeid, Mohamed Shadad, Mostafa Farid, Magdy El Hawary

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The most frequent treatable vascular abnormality of the spinal canal is spinal dural arteriovenous fistulae (SDAVFs), which cause progressive para- or quadriplegia mostly affecting elderly males. SDAVFs are present in the thoracolumbar region. The main goal of treatment must be to obliterate the shunting zone via superselective embolization with the usage of a liquid embolic agent. This study aims to evaluate endovascular technique as a safe and efficient approach for the treatment SDAVFs, especially with long-term follow-up clinical outcomes. Study Design: A retrospective clinical case study. From May 2010 to May 2017, 15 patients who had symptoms attributed to SDAVFs underwent the operation in the Departments of Neurosurgery in Suhag, Tanta, and Al-Azhar Universities and Interventional Radiology, Ain Shams University. All the patients had varying degrees of progressive spastic paraparesis with and without sphincteric disturbances. Endovascular embolization was used in all cases. Fourteen were males, with ages ranging from 45 to 74 years old. After the treatment, good outcome was found in five patients (33.3%), a moderate outcome was delineated in six patients (40 %), and four patients revealed a poor outcome (26.7%). Spinal AVF could be treated safely and effectively by the endovascular approach. Generally, there is no correlation between the disappearance of MRI abnormalities and significant clinical improvement. The preclinical state of the patient is directly proportional to the clinical outcome. Due to unexpected responses, embolization should be attempted even the patient is in a bad clinical condition.

Keywords: spine, arteriovenous, fistula, endovascular, embolization

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12 Audit of TPS photon beam dataset for small field output factors using OSLDs against RPC standard dataset

Authors: Asad Yousuf

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Purpose: The aim of the present study was to audit treatment planning system beam dataset for small field output factors against standard dataset produced by radiological physics center (RPC) from a multicenter study. Such data are crucial for validity of special techniques, i.e., IMRT or stereotactic radiosurgery. Materials/Method: In this study, multiple small field size output factor datasets were measured and calculated for 6 to 18 MV x-ray beams using the RPC recommend methods. These beam datasets were measured at 10 cm depth for 10 × 10 cm2 to 2 × 2 cm2 field sizes, defined by collimator jaws at 100 cm. The measurements were made with a Landauer’s nanoDot OSLDs whose volume is small enough to gather a full ionization reading even for the 1×1 cm2 field size. At our institute the beam data including output factors have been commissioned at 5 cm depth with an SAD setup. For comparison with the RPC data, the output factors were converted to an SSD setup using tissue phantom ratios. SSD setup also enables coverage of the ion chamber in 2×2 cm2 field size. The measured output factors were also compared with those calculated by Eclipse™ treatment planning software. Result: The measured and calculated output factors are in agreement with RPC dataset within 1% and 4% respectively. The large discrepancies in TPS reflect the increased challenge in converting measured data into a commissioned beam model for very small fields. Conclusion: OSLDs are simple, durable, and accurate tool to verify doses that delivered using small photon beam fields down to a 1x1 cm2 field sizes. The study emphasizes that the treatment planning system should always be evaluated for small field out factors for the accurate dose delivery in clinical setting.

Keywords: small field dosimetry, optically stimulated luminescence, audit treatment, radiological physics center

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11 Definition, Barriers to and Facilitators of Moral Distress as Perceived by Neonatal Intensive Care Physicians

Authors: M. Deligianni, P. Voultsos, E. Tsamadou

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Background/Introduction: Moral distress is a common occurrence for health professionals working in neonatal critical care. Despite a growing number of critically ill neonatal and pediatric patients, only a few articles related to moral distress as experienced by neonatal physicians have been published over the last years. Objectives/Aims: The aim of this study was to define and identify barriers to and facilitators of moral distress based on the perceptions and experiences of neonatal physicians working in neonatal intensive care units (NICUs). This pilot study is a part of a larger nationwide project. Methods: A multicenter qualitative descriptive study using focus group methodology was conducted. In-depth interviews lasting 45 to 60 minutes were audio-recorded. Once data were transcribed, conventional content analysis was used to develop the definition and categories, as well as to identify the barriers to and facilitators of moral distress. Results: Participants defined moral distress broadly in the context of neonatal critical care. A wide variation of definitions was displayed. The physicians' responses to moral distress included different feelings and other situations. The overarching categories that emerged from the data were patient-related, family-related, and physician-related factors. Moreover, organizational factors may constitute major facilitators of moral distress among neonatal physicians in NICUs. Note, however, that moral distress may be regarded as an essential component to caring for neonates in critical care. The present study provides further insight into the moral distress experienced by physicians working in Greek NICUs. Discussion/Conclusions: Understanding how neonatal and pediatric critical care nurses define moral distress and what contributes to its development is foundational to developing targeted strategies for mitigating the prevalence of moral distress among neonate physicians in the context of NICUs.

Keywords: critical care, moral distress, neonatal physician, neonatal intensive care unit, NICU

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10 The Psychological Impact of War Trauma on Refugees

Authors: Anastasia Papachristou, Anastasia Ntikoudi, Vasileios Saridakis

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The safety and health care needs of refugees have become an increasingly important issue all over the world especially during last few decades. Wars are the primary reason for refugees to leave their countries. Moreover, refugees are frequently exposed to a variety of stressors such as socioeconomic disadvantages, poverty, changes in family structure and functioning, losing social support, difficulty to access education, living in very crowded places, experiencing racism and isolation. This systematic review included research studies published between 2007-2017 from the search databases Medline, Scopus, Cinahl and PubMed, with keywords 'war survivors', 'war trauma', 'psychiatric disorders', 'refugees'. In order to meet the purpose of the systematic review, further research for complementary studies was conducted into the literature references of the research articles included in this study that would meet the criteria. Overall, 14 studies were reviewed and evaluated. The majority of them demonstrated that the most common psychiatric disorders observed among war refugees are post-traumatic stress disorder (PTSD), depression, anxiety and multiple somatic complaints. Moreover, significant relationship was shown between the number of traumatic events experienced by the refugees and sociodemographic features such as gender, age and previous family history of any psychological disorder. War violence is highly traumatic, causing multiple, long-term negative outcomes such as the aforementioned psychiatric disorders. The number of the studies reviewed in this systematic review is not representative of the problem and its significance. The need for care of the survivors and their families is vital. Further research is necessary in order to clarify the role of predictive factors in the development and maintenance of post-traumatic stress and the rest psychiatric disorders following war trauma. In conclusion, it is necessary to have large multicenter studies in the future in order to be able to draw reliable conclusions about the effects of war.

Keywords: psychiatric disorders, refugees, war survivors, war trauma

Procedia PDF Downloads 155
9 Treatment of Type 2 Diabetes Mellitus: Physicians’ Adherence to the American Diabetes Association Guideline in Central Region, Saudi Arabia

Authors: Ibrahim Mohammed

Abstract:

Background: Diabetes mellitus is a chronic disease that can cause devastating secondary complications, reducing the quality and length of life as well as increasing medical costs for the patient and society. The guidelines recommend both clinical and preventive strategies for diabetes management and are regularly updated. The aim of the study is to assess the level of adherence of physicians to American Diabetes Association Guidelines. Method: Observational multicenter retrospective study will be conducted among different hospitals in the central region. Patient data will be collected from the records of the last three years (2017- 2020). Records will be selected randomly after a complete randomized design. The study focuses on the management of type 2 according to ADA not changed in the last three updating; those standards; all patients should be taking Metformin 1500 to 2000 mg/day as recommended dose and should be received a high dose of statin if the high risk to ASCVD or moderate statin if not at risk, patients with hypertension and diabetes should taking ACE or ARBS. Result: The study aimed to evaluate the commitment of physicians in the central region to the ADA. Out of the 153 selected patients, only 17 % were able to control their diabetes with an average A1c below 7. ADA stated that to reach the minimum benefit of using Metformin, the daily dose should be between 1500 and 2000 mg. Results showed that 110 patients were on Metformin, where 68% of them were on the recommended dose. ADA recommended the intake of high statin for diabetic patients with ASCVD risk, while diabetic patients without ASCVD risk should be on a moderate statin. Results showed that 61.5% of patients with ASCVD risk were at high statin while only 36% of patients without ASCVD risk were at moderate statin. Results showed that 89 patients have hypertension, and 80% of them are getting ACE/ARBs as recommended by the ADA. Recommendation: It is necessary to implement periodic training courses for some physicians to enhance and update their knowledge.

Keywords: American Diabetic Association, diabetes mellitus, atherosclerotic cardiovascular disease, ACE inhibitors

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8 Outcome of Patients Undergoing Hemicraniectomy for Malignant Middle Cerebral Artery Infarction: A 5 Year Retrospective Study at Perpetual Succour Hospital, Cebu City, Philippines

Authors: Adelson G. Guillarte, M. D., Noel J. Belonguel, Jarungchai Anton S. Vatanagul

Abstract:

Patients with malignant middle cerebral infarction (MCA) (with massive brain swelling and herniation) were reported to have a mortality rate of 80% even with the appropriate conservative medical therapy. European Trials (DECIMAL, DESTINY I, and II, HAMLET) showed significant improvement in mortality and functional outcome with hemicraniectomy. No known published local studies in the region, thus a local study is vital. This is a single center, retrospective, descriptive, cross-sectional, chart review study which includes ≥18 year-old patients with malignant MCA infarction, who underwent hemicraniectomy, and those who were given conservative medical therapy alone, from January 2008 to December 2012 at Perpetual Succour Hospital. Excluded were patients whose charts are with insufficient data, prior MCA stroke, with concomitant intracerebral hemorrhage and with other serious medical conditions or terminal illnesses. Minimum of 32 populations were needed. Data were presented in mean, standard deviation, frequency and percentage distribution. Man n Whitney U test and Chi Square test were used. P-values lesser than 0.05 alpha were considered statistically significant. A total of 672 stroke patients were admitted. 34 patients pass the inclusion criteria. 9 underwent hemicraniectomy and 25 were treated by conservative medical therapy alone. Although not statistically significant (64% vs 33%, p=0.112) there were more patients noted improved in the conservative treatment group. Meanwhile, the Hemicraniectomy group have increased percentage of mortality (67%) (p=0.112). There was a decreasing trend in the average NIHSS score in both groups from admission to post-op 7 days (p=0.198, p=0.78). A bigger multicenter prospective study is recommended to control inherent biases and limitations of a retrospective and smaller study.

Keywords: cerebral infarct, hemicraniectomy, ischemic stroke, malignant middle cerebral artery (MCA) infarct

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7 Effectiveness of Gamified Virtual Physiotherapy Patients with Shoulder Problems

Authors: A. Barratt, M. H. Granat, S. Buttress, B. Roy

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Introduction: Physiotherapy is an essential part of the treatment of patients with shoulder problems. The focus of treatment is usually centred on addressing specific physiotherapy goals, ultimately resulting in the improvement in pain and function. This study investigates if computerised physiotherapy using gamification principles are as effective as standard physiotherapy. Methods: Physiotherapy exergames were created using a combination of commercially available hardware, the Microsoft Kinect, and bespoke software. The exergames used were validated by mapping physiotherapy goals of physiotherapy which included; strength, range of movement, control, speed, and activation of the kinetic chain. A multicenter, randomised prospective controlled trial investigated the use of exergames on patients with Shoulder Impingement Syndrome who had undergone Arthroscopic Subacromial Decompression surgery. The intervention group was provided with the automated sensor-based technology, allowing them to perform exergames and track their rehabilitation progress. The control group was treated with standard physiotherapy protocols. Outcomes from different domains were used to compare the groups. An important metric was the assessment of shoulder range of movement pre- and post-operatively. The range of movement data included abduction, forward flexion and external rotation which were measured by the software, pre-operatively, 6 weeks and 12 weeks post-operatively. Results: Both groups show significant improvement from pre-operative to 12 weeks in elevation in forward flexion and abduction planes. Results for abduction showed an improvement for the interventional group (p < 0.015) as well as the test group (p < 0.003). Forward flexion improvement was interventional group (p < 0.0201) with the control group (p < 0.004). There was however no significant difference between the groups at 12 weeks for abduction (p < 0.118067) , forward flexion (p < 0.189755) or external rotation (p < 0.346967). Conclusion: Exergames may be used as an alternative to standard physiotherapy regimes; however, further analysis is required focusing on patient engagement.

Keywords: shoulder, physiotherapy, exergames, gamification

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6 Field Prognostic Factors on Discharge Prediction of Traumatic Brain Injuries

Authors: Mohammad Javad Behzadnia, Amir Bahador Boroumand

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Introduction: Limited facility situations require allocating the most available resources for most casualties. Accordingly, Traumatic Brain Injury (TBI) is the one that may need to transport the patient as soon as possible. In a mass casualty event, deciding when the facilities are restricted is hard. The Extended Glasgow Outcome Score (GOSE) has been introduced to assess the global outcome after brain injuries. Therefore, we aimed to evaluate the prognostic factors associated with GOSE. Materials and Methods: In a multicenter cross-sectional study conducted on 144 patients with TBI admitted to trauma emergency centers. All the patients with isolated TBI who were mentally and physically healthy before the trauma entered the study. The patient’s information was evaluated, including demographic characteristics, duration of hospital stays, mechanical ventilation on admission laboratory measurements, and on-admission vital signs. We recorded the patients’ TBI-related symptoms and brain computed tomography (CT) scan findings. Results: GOSE assessments showed an increasing trend by the comparison of on-discharge (7.47 ± 1.30), within a month (7.51 ± 1.30), and within three months (7.58 ± 1.21) evaluations (P < 0.001). On discharge, GOSE was positively correlated with Glasgow Coma Scale (GCS) (r = 0.729, P < 0.001) and motor GCS (r = 0.812, P < 0.001), and inversely with age (r = −0.261, P = 0.002), hospitalization period (r = −0.678, P < 0.001), pulse rate (r = −0.256, P = 0.002) and white blood cell (WBC). Among imaging signs and trauma-related symptoms in univariate analysis, intracranial hemorrhage (ICH), interventricular hemorrhage (IVH) (P = 0.006), subarachnoid hemorrhage (SAH) (P = 0.06; marginally at P < 0.1), subdural hemorrhage (SDH) (P = 0.032), and epidural hemorrhage (EDH) (P = 0.037) were significantly associated with GOSE at discharge in multivariable analysis. Conclusion: Our study showed some predictive factors that could help to decide which casualty should transport earlier to a trauma center. According to the current study findings, GCS, pulse rate, WBC, and among imaging signs and trauma-related symptoms, ICH, IVH, SAH, SDH, and EDH are significant independent predictors of GOSE at discharge in TBI patients.

Keywords: field, Glasgow outcome score, prediction, traumatic brain injury.

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5 Knowledge, Attitude and Associated Factors of Practice towards Post Exposure Prophylaxis of HIV Infection among Health Professionals in Yeka and Kazanchis Health Center

Authors: Semira Zeru Haileslassie

Abstract:

Lack of awareness and practices of PEP treatment were observed among respondents, but they had a better attitude towards PEP. To this end, a formal training for all respondents regarding PEP for HIV prior to their clinical attachments is of utmost importance. The training ought to incorporate a brief clarification with respect to the unpleasant impact of non-adherence that essentially incorporate destitute treatment result and most prominent hazard of resistance and few given as a major cause for non-compliance to PEP, common transient side-effects of PEP and its administrations ought to be cloister educated healthcare specialists to diminish its effect on adherence. Besides, the propensity of detailing needle adhere harm was destitute that needs endeavors to progress. Progressing the culture of detailing and making the detailing handle simple is very necessary. In reality, announcing such wounds as early as conceivable will educate others not to commit same issue once more and, for the most part, will empower stakeholders to intercede the issue sometime prior to it re-occur. At long last, as distant as get up and go utilize has cleared out with so numerous bothers, risk decrease is the foremost choice. With this, taking the increased significance of protective barriers so as to decrease the hazard of exposure to HIV, distinctive stakeholders (the healing center hardware supply chain director, the HIV/ Helps clinic, the clinic chief, hardware and supply quality confirmation group, and other authoritative bodies) ought to work together in co-ordination to secure the supply and guarantee the quality of those crucial protective barriers and to advance demand health laborers to continuously wear protective barriers when exposed to HIV hazard components as well as to dispose appropriately once done. At long last, we prescribe future examiners to conduct planned multicenter studies with extra goals (counting indicator investigation) for way better generalization and result. In spite of satisfactory information and favorable state of mind towards PEP for HIV in most of the respondents, this study uncovered that there were delays in starting, low utilization, and fragmented use of the prescribed PEP. So, health care staff need to progress their practice on PEP of HIV through diverse training program related to PEP of HIV.

Keywords: HIV infection, prophylaxis, knowledge, attitude

Procedia PDF Downloads 153
4 Relationshiop Between Occupants' Behaviour And Indoor Air Quality In Malaysian Public Hospital Outpatient Department

Authors: Farha Ibrahim, Ely Zarina Samsudin, Ahmad Razali Ishak, Jeyanthini Sathasivam

Abstract:

Introduction: Indoor air quality (IAQ) has recently gained substantial traction as the airborne transmission of infectious respiratory disease has become an increasing public health concern. Public hospital outpatient department (OPD). IAQ warrants special consideration as it is the most visited department in which patients and staff are all directly impacted by poor IAQ. However, there is limited evidence on IAQ in these settings. Moreover, occupants’ behavior like occupant’s movement and operation of door, windows and appliances, have been shown to significantly affect IAQ, yet the influence of these determinants on IAQ in such settings have not been established. Objectives: This study aims to examine IAQ in Malaysian public hospitals OPD and assess its relationships with occupants’ behavior. Methodology: A multicenter cross-sectional study in which stratified random sampling of Johor public hospitals OPD (n=6) according to building age was conducted. IAQ measurements include indoor air temperature, relative humidity (RH), air velocity (AV), carbon dioxide (CO2), total bacterial count (TBC) and total fungal count (TFC). Occupants’ behaviors in Malaysian public hospital OPD are assessed using observation forms, and results were analyzed. Descriptive statistics were performed to characterize all study variables, whereas non-parametric Spearman Rank correlation analysis was used to assess the correlation between IAQ and occupants’ behavior. Results: After adjusting for potential cofounder, the study has suggested that occupants’ movement in new building, like seated quietly, is significantly correlated with AV in new building (r 0.642, p-value 0.010), CO2 in new (r 0.772, p-value <0.001) and old building (r -0.559, p-value 0.020), TBC in new (r 0.747, p-value 0.001) and old building (r -0.559, p-value 0.020), and TFC in new (r 0.777, p-value <0.001) and old building (r -0.485, p-value 0.049). In addition, standing relaxed movement is correlated with indoor air temperature (r 0.823, p-value <0.001) in new building, CO2 (r 0.559, p-value 0.020), TBC (r 0.559, p-value 0.020), and TFC (r -0.485, p-value 0.049) in old building, while walking is correlated with AV in new building (r -0.642, p-value 0.001), CO2 in new (r -0.772, p-value <0.001) and old building (r 0.559, p-value 0.020), TBC in new (r -0.747, p-value 0.001) and old building (r 0.559, p-value 0.020), and TFC in old building (r -0.485, p-value 0.049). The indoor air temperature is significantly correlated with number of doors kept opened (r 0.522, p-value 0.046), frequency of door adjustments (r 0.753, p-value 0.001), number of windows kept opened (r 0.522, p-value 0.046), number of air-conditioned (AC) switched on (r 0.698, p-value 0.004) and frequency of AC adjustment (r 0.753, p-value 0.001) in new hospital OPD building. AV is found to be significantly correlated with number of doors kept opened (r 0.642, p-value 0.01), frequency of door adjustments (r 0.553, p-value 0.032), number of windows kept opened (r 0.642, p-value 0.01), and frequency of AC adjustment, number of fans switched on, and frequency of fans adjustment(all with r 0.553, p-value 0.032) in new building. In old hospital OPD building, the number of doors kept opened is significantly correlated with CO₂, TBC (both r -0.559, p-value 0.020) and TFC (r -0.495, p-value 0.049), frequency of door adjustment is significantly correlated with CO₂, TBC (both r-0.559, p-value 0.020) and TFC (r -0.495, p-value 0.049), number of windows kept opened is significantly correlated with CO₂, TBC (both r 0.559, p-value 0.020) and TFC (r 0.495, p-value 0.049), frequency of window adjustment is significantly correlated with CO₂,TBC (both r -0.559, p-value 0.020) and TFC (r -0.495, p-value 0.049), number of AC switched on is significantly correlated with CO₂, TBC (both r -0.559, p-value 0.020) and TFC (r -0.495, p-value 0.049),, frequency of AC adjustment is significantly correlated with CO2 (r 0.559, p-value 0.020), TBC (0.559, p-value 0.020) and TFC (r -0.495, p-value 0.049), number of fans switched on is significantly correlated with CO2, TBC (both r 0.559, p-value 0.020) and TFC (r 0.495, p-value 0.049), and frequency of fans adjustment is significantly correlated with CO2, TBC (both r -0.559, p-value 0.020) and TFC (r -0.495, p-value 0.049). Conclusion: This study provided evidence on IAQ parameters in Malaysian public hospitals OPD and significant factors that may be effective targets of prospective intervention, thus enabling stakeholders to develop appropriate policies and programs to mitigate IAQ issues in Malaysian public hospitals OPD.

Keywords: outpatient department, iaq, occupants practice, public hospital

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3 Clinical Response of Nuberol Forte® (Paracetamol 650 MG+Orphenadrine 50 MG) For Pain Management with Musculoskeletal Conditions in Routine Pakistani Practice (NFORTE-EFFECT)

Authors: Shahid Noor, Kazim Najjad, Muhammad Nasir, Irshad Bhutto, Abdul Samad Memon, Khurram Anwar, Tehseen Riaz, Mian Muhammad Hanif, Nauman A. Mallik, Saeed Ahmed, Israr Ahmed, Ali Yasir

Abstract:

Background: Musculoskeletal pain is the most common complaint presented to the health practitioner. It is well known that untreated or under-treated pain can have a significant negative impact on an individual’s quality of life (QoL). Objectives: This study was conducted across 10 sites in six (6) major cities of Pakistan to evaluate the tolerability, safety, and the clinical response of Nuberol Forte® (Paracetamol 650 mg + Orphenadrine 50 mg) to musculoskeletal pain in routine Pakistani practice and its impact on improving the patient’s QoL. Design & Methods: This NFORT-EFFECT observational, prospective multicenter study was conducted in compliance with Good Clinical Practice guidelines and local regulatory requirements. The study sponsor was "The Searle Company Limited, Pakistan. To maintain the GCP compliances, the sponsor assigned the CRO for the site and data management. Ethical approval was obtained from an independent ethics committee. The IEC reviewed the progress of the study. Written informed consent was obtained from the study participants, and their confidentiality was maintained throughout the study. A total of 399 patients with known prescreened musculoskeletal conditions and pain who attended the study sites were recruited, as per the inclusion/exclusion criteria (clinicaltrials.gov ID# NCT04765787). The recruited patients were then prescribed Paracetamol (650 mg) and Orphenadrine (50 mg) combination (Nuberol Forte®) for 7 to 14 days as per the investigator's discretion based on the pain intensity. After the initial screening (visit 1), a follow-up visit was conducted after 1-2 weeks of the treatment (visit 2). Study Endpoints: The primary objective was to assess the pain management response of Nuberol Forte treatment and the overall safety of the drug. The Visual Analogue Scale (VAS) scale was used to measure pain severity. Secondary to pain, the patients' health-related quality of life (HRQoL) was also assessed using the Muscle, Joint Measure (MJM) scale. The safety was monitored on the first dose by the patients. These assessments were done on each study visit. Results: Out of 399 enrolled patients, 49.4% were males, and 50.6% were females with a mean age of 47.24 ± 14.20 years. Most patients were presented with Knee Osteoarthritis (OA), i.e., 148(38%), followed by backache 70(18.2%). A significant reduction in the mean pain score was observed after the treatment with the combination of Paracetamol and Orphenadrine (p<0.05). Furthermore, an overall improvement in the patient’s QoL was also observed. During the study, only ten patients reported mild adverse events (AEs). Conclusion: The combination of Paracetamol and Orphenadrine (Nuberol Forte®) exhibited effective pain management among patients with musculoskeletal conditions and also improved their QoL.

Keywords: musculoskeletal pain, orphenadrine/paracetamol combination, pain management, quality of life, Pakistani population

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2 Correlation between the Levels of Some Inflammatory Cytokines/Haematological Parameters and Khorana Scores of Newly Diagnosed Ambulatory Cancer Patients

Authors: Angela O. Ugwu, Sunday Ocheni

Abstract:

Background: Cancer-associated thrombosis (CAT) is a cause of morbidity and mortality among cancer patients. Several risk factors for developing venous thromboembolism (VTE) also coexist with cancer patients, such as chemotherapy and immobilization, thus contributing to the higher risk of VTE in cancer patients when compared to non-cancer patients. This study aimed to determine if there is any correlation between levels of some inflammatory cytokines/haematological parameters and Khorana scores of newly diagnosed chemotherapy naïve ambulatory cancer patients (CNACP). Methods: This was a cross-sectional analytical study carried out from June 2021 to May 2022. Eligible newly diagnosed cancer patients 18 years and above (case group) were enrolled consecutively from the adult Oncology Clinics of the University of Nigeria Teaching Hospital, Ituku/Ozalla (UNTH). The control group was blood donors at UNTH Ituku/Ozalla, Enugu blood bank, and healthy members of the Medical and Dental Consultants Association of Nigeria (MDCAN), UNTH Chapter. Blood samples collected from the participants were assayed for IL-6, TNF-Alpha, and haematological parameters such as haemoglobin, white blood cell count (WBC), and platelet count. Data were entered into an Excel worksheet and were then analyzed using Statistical Package for Social Sciences (SPSS) computer software version 21.0 for windows. A P value of < 0.05 was considered statistically significant. Results: A total of 200 participants (100 cases and 100 controls) were included in the study. The overall mean age of the participants was 47.42 ±15.1 (range 20-76). The sociodemographic characteristics of the two groups, including age, sex, educational level, body mass index (BMI), and occupation, were similar (P > 0.05). Following One Way ANOVA, there were significant differences between the mean levels of interleukin-6 (IL-6) (p = 0.036) and tumor necrotic factor-α (TNF-α) (p = 0.001) in the three Khorana score groups of the case group. Pearson’s correlation analysis showed a significant positive correlation between the Khorana scores and IL-6 (r=0.28, p = 0.031), TNF-α (r= 0.254, p= 0.011), and PLR (r= 0.240, p=0.016). The mean serum levels of IL-6 were significantly higher in CNACP than in the healthy controls [8.98 (8-12) pg/ml vs. 8.43 (2-10) pg/ml, P=0.0005]. There were also significant differences in the mean levels of the haemoglobin (Hb) level (P < 0.001)); white blood cell (WBC) count ((P < 0.001), and platelet (PL) count (P = 0.005) between the two groups of participants. Conclusion: There is a significant positive correlation between the serum levels of IL-6, TNF-α, and PLR and the Khorana scores of CNACP. The mean serum levels of IL-6, TNF-α, PLR, WBC, and PL count were significantly higher in CNACP than in the healthy controls. Ambulatory cancer patients with high-risk Khorana scores may benefit from anti-inflammatory drugs because of the positive correlation with inflammatory cytokines. Recommendations: Ambulatory cancer patients with 2 Khorana scores may benefit from thromboprophylaxis since they have higher Khorana scores. A multicenter study with a heterogeneous population and larger sample size is recommended in the future to further elucidate the relationship between IL-6, TNF-α, PLR, and the Khorana scores among cancer patients in the Nigerian population.

Keywords: thromboprophylaxis, cancer, Khorana scores, inflammatory cytokines, haematological parameters

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1 A Second Chance to Live and Move: Lumbosacral Spinal Cord Ischemia-Infarction after Cardiac Arrest and the Artery of Adamkiewicz

Authors: Anna Demian, Levi Howard, L. Ng, Leslie Simon, Mark Dragon, A. Desai, Timothy Devlantes, W. David Freeman

Abstract:

Introduction: Out-of-hospital cardiac arrest (OHCA) can carry a high mortality. For survivors, the most common complication is hypoxic-ischemic brain injury (HIBI). Rarely, lumbosacral spinal cord and/or other spinal cord artery ischemia can occur due to anatomic variation and variable mean arterial pressure after the return of spontaneous circulation. We present a case of an OHCA survivor who later woke up with bilateral leg weakness with preserved sensation (ASIA grade B, L2 level). Methods: We describe a clinical, radiographic, and laboratory presentation, as well as a National Library of Medicine (NLM) search engine methodology, characterizing incidence/prevalence of this entity is discussed. A 70-year-old male, a longtime smoker, and alcohol user, suddenly collapsed at a bar surrounded by friends. He had complained of chest pain before collapsing. 911 was called. EMS arrived, and the patient was in pulseless electrical activity (PEA), cardiopulmonary resuscitation (CPR) was initiated, and the patient was intubated, and a LUCAS device was applied for continuous, high-quality CPR in the field by EMS. In the ED, central lines were placed, and thrombolysis was administered for a suspected Pulmonary Embolism (PE). It was a prolonged code that lasted 90 minutes. The code continued with the eventual return of spontaneous circulation. The patient was placed on an epinephrine and norepinephrine drip to maintain blood pressure. ECHO was performed and showed a “D-shaped” ventricle worrisome for PE as well as an ejection fraction around 30%. A CT with PE protocol was performed and confirmed bilateral PE. Results: The patient woke up 24 hours later, following commands, and was extubated. He was found paraplegic below L2 with preserved sensation, with hypotonia and areflexia consistent with “spinal shock” or anterior spinal cord syndrome. MRI thoracic and lumbar spine showed a conus medullaris level spinal cord infarction. The patient was given IV steroids upon initial discovery of cord infarct. NLM search using “cardiac arrest” and “spinal cord infarction” revealed 57 results, with only 8 review articles. Risk factors include age, atherosclerotic disease, and intraaortic balloon pump placement. AoA (Artery of Adamkiewicz) anatomic variation along with existing atherosclerotic factors and low perfusion were also known risk factors. Conclusion: Acute paraplegia from anterior spinal cord infarction of the AoA territory after cardiac arrest is rare. Larger prospective, multicenter trials are needed to examine potential interventions of hypothermia, lumbar drains, which are sometimes used in aortic surgery to reduce ischemia and/or other neuroprotectants.

Keywords: cardiac arrest, spinal cord infarction, artery of Adamkiewicz, paraplegia

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