Wilcoxon Matched-pairs Signed-rank Test Research Articles

PD51-08 RADICAL CYSTECTOMY AND ORTHOTOPIC NEOBLADDER IN WOMEN

INTRODUCTION AND OBJECTIVE: Available data regarding long-term survival and functional outcomes after surgery are limited. Herein, we report on the long-term survival and functional outcome, 10 years or more after RC. METHODS: We retrieved all electronic data of the prospectively evaluated women who underwent RC and ONB in our institute between 1995 and 2009. Patients’ demographics including early and late complications were retrieved. Cancer-specific survival and overall survival were assessed. Patients completed ≥10 years of follow-up were evaluated for continence, voiding status and renal function. Renal function was estimated using serum creatinine (Sr.Cr) and eGFR (measured by Modification of Diet in Kidney Disease Equation) and compared to preoperative values using Wilcoxon matched-pair signed-rank test. Significant renal function changes (improvement or deterioration) were considered when > 20% changes in eGFR occurred in comparison to preoperative value. Univariate and multivariate analysis were performed to determine predictors of renal function deterioration. RESULTS: The study included 297 patients with mean± SD age of 51.3±9.1 years. Patients’ demographic criteria were illustrated in table 1. At a median (range) follow up of 78 (0-247) months, CSS and OS were 78.1% and 62%, respectively (Figure 1). Among 184 disease-free living patients, 95 were lost follow-up after 67.5 (12-109) months of follow up. Eighty nine completed more than 10 years (164.5±34.7 months) of follow up. At last follow-up, 80 patients (90%) were totally continent at daytime; 3 of them achieved continence after treatment of chronic urinary retention (CUR) by clean intermittent catheterization (CIC). The remaining 9 patients had total (3) or varying degrees of stress (6) urinary incontinence. Night time continence was achieved in 56 patients (63%); 8 of them were having CUR and cured by CIC and anticholinergics. CUR was noted in 29 (32.6%) patients. Compared to preoperative values, there were statistically significant increase in serum creatinine [0.8 (0.5-1.5) to 1 (0.5-5.3), P<0.001] and decrease in eGFR [84.4 (46-134) to 65.3 (11-125), P< 0.001]. Six (6.7%) and three (3.4%) patients developed grade IV and grade V CKD, respectively. Forty six (51.7%) and 43 (48.3%) patients showed significant decline and static renal function, respectively. In univariate analysis, young patients’ age, higher serum Cr, lower eGFR and DM were the predictors of renal function decline (P<0.05). In multivariate analysis, only DM was the independent predictor of renal function decline [OR (95%CI)= 12.7 (1.15-41.38), p=0.03]. CONCLUSIONS: Ten years after RC and ONB in women, 30% are disease-free and have acceptable continence status. Although a decline in kidney function is noted in 50% of the cases, only 10% develop ESRD. Diabetes mellitus has been proved to be an independent predictor of renal function decline.IDyGZAAAAAElFTkSuQmCC"> Source of Funding: no funding

Minimally invasive esophagectomy is associated with superior survival, lymphadenectomy and surgical margins: propensity matched analysis of the National Cancer Database.

Despite excellent short-term outcomes of minimally invasive esophagectomy (MIE), there is minimal data on long-term outcomes compared to open esophagectomy. MIE's superior visualization may have improved lymphadenectomy and complete resection rate and therefore improved long-term outcomes. We hypothesized that MIE would have superior long-term survival. Patients undergoing an esophagectomy for cancer between 2010 and 2016 were identified in the National Cancer Database. MIE included laparoscopic/robotic approach, and conversions were categorized as open. A 1:1 propensity match was performed. Lymphadenectomy and margin status were compared between MIE and open using Stuart Maxwell marginal homogeneity and Wilcoxon matched-pair signed-rank test. Survival was compared using log-rank test. 13,083 patients were identified: 8,906 (68%) open and 4,177 (32%) MIE. Propensity matching identified 3,659 'pairs' of MIE and open esophagectomy patients. Among them, MIE was associated with higher number lymph nodes examined (16 vs. 14, P < 0.001) and similar number of positive lymph nodes (0 vs. 0, P = 0.33). MIE had higher rate of negative pathologic margin (95 vs. 93.5%, P < 0.001). MIE was also associated with shorter hospitalization (9 vs. 10days, P < 0.001). Survival was improved among MIE patients (46.6 vs. 41.4months for open, P = 0.003) and among pathologic node-negative patients (71.4 vs. 61.5months, P = 0.005). These data suggest that MIE has improved short-term outcomes (improved lymphadenectomy, pathologic margins, and length of stay) and also associated improved overall survival. The etiology of superior overall survival is likely secondary to many factors related and unrelated to surgical approach.

Fat Grafting Improves Fibrosis and Scarring in Vulvar Lichen Sclerosus: Results From a Prospective Cohort Study.

The aim of the study was to evaluate the effect of lipotransfer in women presenting with fibrosis and scarring due to lichen sclerosus. This prospective cohort study included 33 women attending the vulvar clinic of a public hospital. Patients received one lipotransfer treatment. Validated measures were used prospectively to assess the sexual function (Female Sexual Function Index, Female Sexual Distress Scale); symptoms (visual analog scale for itching, burning, soreness), pain (Pain Anxiety Symptoms Scale 20); psychological status and quality of life (Hospital Anxiety and Depression Scale, Relationship Assessment Scale, Wound Management Questionnaire Revised); physician-based disease signs (Vulvar Architecture Severity Scale). Data were analyzed using paired t test with nonparametric Wilcoxon matched-pairs signed rank test and unpaired t test with nonparametric Mann-Whitney test (Prism6 Software). The mean (SD) follow-up was 12.9 (3.5) months. Sexual function improved after treatment (p < .001), as well as the distress associated with sexuality (p < .0001). A significant improvement was reported in itching (p < .001), burning (p < .05), soreness (p < .001), and pain (p < .0001). Patients reported a significant improvement in romantic relationship (p < .05), anxiety (p < .0001), and depression (p < .0001). Improvement was not significant in the self-care associated with self-disgust assessment (p = .42). The clinical physician-based score showed an overall improvement in all the treated areas to lesser or greater extent. The use of fat grafting in lichen sclerosus is promising. Further studies are required to rule out a potential placebo effect and to better understand the underlying molecular mechanism of action.

Intravitreal bromfenac liposomal suspension (100 μg / 0.1 ml). A safety study in rabbit eyes

IntroductionThere is a need to find alternative treatments for MEe. Bromfenac has shown promise in inhibiting the COX-2 enzymatic pathway that partially causes the inflammatory cascade which contributes to the precipitation of ME. However, like other NSAID's, its intraocular half-life is limited. We hypothesize that a delayed-release liposome formulation containing bromfenac might provide a similar anti-inflammatory effect as long-lasting steroid release systems without the well-known steroidal side-effects. We introduced a novel formulation with these characteristics into the vitreous cavity of rabbit eyes in order to evaluate its safety profile. Material and methods10 left eyes of rabbits were injected with the liposome-encapsulated bromfenac suspension (100 μg/0.1 ml). Basal ERG's were recorded. Total follow-up time was 3 months, at which point ERG's were repeated and eyes were enucleated for histopathological study. Total amplitude and implicit times were recorded. A difference of 25% in either recording was considered significant. Significance was assessed using the paired-t test and Wilcoxon matched-pairs signed-rank test. A p-value of <0.05 was considered significant. ResultsNo significant changes were recorded in ERG measurements after 3 months when compared to basal measurements. Histopathological analysis of retinal specimens found no traces of liposome-induced toxicity. ConclusionThe liposome-encapsulated bromfenac suspension (100 μg/0.1 ml) is not toxic and has been proven safe to use in an animal model. Therefore, this formulation shows promise as a possible future alternative treatment for ME and should be further studied to show its biological effect and efficacy.

Comparing verbal autopsy cause of death findings as determined by physician coding and probabilistic modelling: a public health analysis of 54 000 deaths in Africa and Asia.

BackgroundCoverage of civil registration and vital statistics varies globally, with most deaths in Africa and Asia remaining either unregistered or registered without cause of death. One important constraint has been a lack of fit–for–purpose tools for registering deaths and assigning causes in situations where no doctor is involved. Verbal autopsy (interviewing care–givers and witnesses to deaths and interpreting their information into causes of death) is the only available solution. Automated interpretation of verbal autopsy data into cause of death information is essential for rapid, consistent and affordable processing.MethodsVerbal autopsy archives covering 54 182 deaths from five African and Asian countries were sourced on the basis of their geographical, epidemiological and methodological diversity, with existing physician–coded causes of death attributed. These data were unified into the WHO 2012 verbal autopsy standard format, and processed using the InterVA–4 model. Cause–specific mortality fractions from InterVA–4 and physician codes were calculated for each of 60 WHO 2012 cause categories, by age group, sex and source. Results from the two approaches were assessed for concordance and ratios of fractions by cause category. As an alternative metric, the Wilcoxon matched–pairs signed ranks test with two one–sided tests for stochastic equivalence was used.FindingsThe overall concordance correlation coefficient between InterVA–4 and physician codes was 0.83 (95% CI 0.75 to 0.91) and this increased to 0.97 (95% CI 0.96 to 0.99) when HIV/AIDS and pulmonary TB deaths were combined into a single category. Over half (53%) of the cause category ratios between InterVA–4 and physician codes by source were not significantly different from unity at the 99% level, increasing to 62% by age group. Wilcoxon tests for stochastic equivalence also demonstrated equivalence.ConclusionsThese findings show strong concordance between InterVA–4 and physician–coded findings over this large and diverse data set. Although these analyses cannot prove that either approach constitutes absolute truth, there was high public health equivalence between the findings. Given the urgent need for adequate cause of death data from settings where deaths currently pass unregistered, and since the WHO 2012 verbal autopsy standard and InterVA–4 tools represent relatively simple, cheap and available methods for determining cause of death on a large scale, they should be used as current tools of choice to fill gaps in cause of death data.

The role of Egyptian State Awards in changing researchers’ performance in the science and technology sector

AbstractEgyptians generally pay attention to the State Awards as the most prestigious awards that Egyptian researchers can receive, including the Nile Award, the State Appreciation Award, the State Award of Excellence, and the State Encouragement Award. The current study is an attempt to investigate the role of national awards in the scientific research system, in order to identify the characteristics of Egyptian State Award laureates in science and technology during 2012–5, to determine their international literature, and to explore the implications of receiving a national award using bibliometric indicators. Scopus database was used to extract data, and the statistical software package SPSS was used to analyze. The study sample was 212 laureates, in addition to the control group of 184 researchers who closely matches the academic profiles of the laureates. The performance of the laureates and the control group was compared before and after the award by using four bibliometric indicators and the Wilcoxon matched-pairs signed-ranks test. The laureates produced 13,598 publications from 1958 to 2018. Most of the laureates’ literature (94.35%) were published with coauthors. The Egyptian State Award laureates often collaborate with their Saudi Arabian and American colleagues, more than others. The average values of publications, citations, and citations per publication have increased after receipt of the award, unlike the h-index. Results indicated that receiving the State Award has a negative impact on the laureates’ performance.

Immunogenicity and Safety of the Adjuvanted Recombinant Zoster Vaccine in Adult Hematopoietic Cell Transplant Recipients: A Single Center Study

<h3>Background</h3> Hematopoietic cell transplant (HCT) recipients are at high risk for Varicella zoster virus (VZV) reactivation. Shingrix, the adjuvanted recombinant zoster vaccine, is a new alternative to the live-attenuated VZV vaccine for immunocompromised individuals. Post-marketing data on its immunogenicity and safety in HCT is limited. <h3>Objectives</h3> To assess the safety and immunogenicity of Shingrix vaccine in HCT recipients. <h3>Methods</h3> Single center retrospective study of 134 consecutive adult allogenic and autologous HCT recipients who received the full series (two doses) of Shingrix vaccine. Primary study end points were safety and immunogenicity defined as either seroconversion in previously seronegative individuals or 4-fold increase from baseline VZV IgG titers in previously exposed patients. <h3>Results</h3> Among the 134 patients who completed vaccine series, 39 patients including 25 allogeneic and 14 autologous HCT recipients (Figure), had serological data available at baseline and after completion of vaccine series. The median age of patients at the time of HCT was 61 years (IQR, 53-67). The median time from HCT to first dose of Shingrix vaccine was 9 months (IQR, 7-14) for the entire cohort, but it was significantly shorter in autologous versus allogeneic HCT recipients: 7 (IQR, 6-8) vs. 12 (IQR, 9-16) months (P=0.003 by Mann Whitney test), respectively. Vaccine administration was very well tolerated, out of 134 patients only two (1.4%) had documented adverse events following Shingrix (and other vaccines co-administered), including injection site reaction after second dose and flu-like syndrome with fatigue and non-productive cough after the first dose (n=1 each). Both reactions occurred in autologous HCT recipients. The median time from the second Shingrix dose to post-vaccination VZV IgG titer assessment was 3.5 (IQR, 2-6) months. A total of 16 (41%) patients had documented humoral vaccine responses as measured by post vaccination VZV IgG levels including 8/14 (57%) autologous HCT recipients compared to 8/25 (32%) allogeneic HCT recipients (P=0.18 by Fisher's exact test). Among the 16 responders, the VZV IgG antibody concentration index increased from 179 (2.1-559) to 3,868 (2,232-4,000) (P<0.0001 by Wilcoxon matched-pairs signed rank test). Of interest, 100% of the patients who were seronegative prior to vaccination (n=8) seroconverted in response to Shingrix. <h3>Conclusions</h3> A 2-dose course of adjuvanted recombinant zoster vaccine was well tolerated among adult HCT recipients. Vaccine humoral responses occurred in less than half of the patients although vaccine seems to be more immunogenic following autologous HCT and among seronegative patients. Although Shingrix vaccine is currently only licensed for VZV seropositive patients, our data indicate that this recombinant vaccine may also be useful for primary VZV immunization. Larger studies are needed.

Management of chronic testicular pain due to thoracolumbar junction syndrome: A pilot study

Thoracolumbar dysfunction (TLD) had been evoked as a possible etiology of chronic testicular pain. Our study investigated the efficacy of osteopathic diagnosis and treatment of TLD in men with chronic testicular pain. Patients suffering from testicular pain were examined for thoracolumbar dysfunction and enrolled in a prospective trial if they have both conditions. Following standardized examination, all patients were prescribed 1 to 3 osteopathic treatment sessions, usually at weekly interval. Treatment success was evaluated using the Visual Analog scale and durability was assessed by regular follow-up. Patient satisfaction was also assessed. Comparison of pain improvement was done using Wilcoxon matched-pairs signed-ranks test. Logistic regression was used to assess for risk factors of success. A P<0.001 was used for significance. Out of 62 patients enrolled, 41 patients (median age 32 years, IQR 24-37) were suffering from chronic testicular pain and TLD. 37 of the 41 participants completed the treatment and follow-up according to the plan. Patients underwent a median of 2 osteopathic treatment sessions (range 1-3). Overall, pain disappeared completely in 25 patients (67.5%) and improvement was noted in 7 patients (18.9%). After initial improvement, two patients experienced relapse at their last visit (5.4%). Five patients (13.5%) had no improvement of their symptoms after osteopathic treatment. Statistically, improvement was significant with a P<0.001 and on logistic regression, site of pain and duration of pain were the sole predictors of failure. TLD is a pathology that should be considered in the differential diagnosis in patients with chronic testicular pain and osteopathic manipulation of the spine appears to be an effective treatment option.

Higher preoperative pain catastrophizing increases the risk of low patient reported satisfaction after carpal tunnel release: a prospective study

BackgroundCarpal tunnel syndrome is a common upper-limb nerve compression disease. Carpal tunnel syndrome can lead to several symptoms such as tingling or numbness, pain in the hand or wrist, and reduced grip strength. Based on demographic characteristics, patient reported outcome measures, and with special attention to pain catastrophizing, the purpose of this study was to identify risk factors for low patient-reported satisfaction following surgical treatment of idiopathic carpal tunnel syndrome.MethodsA total of 417 hands from 417 patients (64. 5% females) with a mean age of 58. 0 years were included in this 1-year prospective follow-up study. We collected preoperative data on disability using the Disability of the Arm, Shoulder and Hand questionnaire (DASH), quality of life using the EuroQol-5D (EQ-5D), pain catastrophizing using the Pain Catastrophizing Scale (PCS) and distal motor latency. Data on DASH score, EQ-5D, and patient satisfaction was collected 12 months postoperatively. Wilcoxon matched-pairs signed-rank test was used to test for difference in preoperative and postoperative DASH and EQ-5D score. Risk factors for low postoperative patient reported satisfaction was examined using stepwise multiple logistic regression analysis.ResultsWe found a general improvement in patients’ DASH scores (12.29 [95% CI: 10.65–13.90], p < 0.001) and EQ-5D (0.14 [95% CI: 0.13–0.16], p < 0.001) from preoperative to 12 months postoperative. In the fully adjusted multiple regression analysis we found a statistically significant effect of preoperative PCS on patient reported satisfaction with OR = 1.05 (p = 0.022), for a one unit increase in preoperative PCS. There was no statistically significant predictive effect of preoperative EQ-5D (p = 0.869), DASH (p = 0.076), distal motor latency (p = 0.067), age (p = 0.505) or gender (p = 0.222).ConclusionsPatients improved in both DASH and EQ-5D from preoperative to 12 months postoperative. Higher preoperative PCS seems to have a negative effect on postoperative patient reported satisfaction after carpal tunnel release.

DOP83 Intestinal fibrosis in Crohn’s disease patients is marked by up-regulation of innate immune cells and mucosal B cells

Abstract Background Intestinal fibrosis represents a significant complication of inflammatory bowel disease (IBD). An urgent need is present for the identification of pathways and markers involved in fibrogenesis to prevent and intervene with intestinal fibrosis. As intestinal fibrosis mainly occurs in the intestinal deeper layers, mucosal biopsies for studies in intestinal fibrosis are of limited information. Therefore, characterisation of the relative contribution of innate and adaptive immune cells in the mucosa and deeper layers in fibrotic distal ileum of Crohn’s disease (CD) patients was performed. Methods Seventeen CD patients undergoing right hemicolectomy (RHC) for stricturing disease and 6 colorectal cancer (CRC) patients undergoing RHC were recruited. The resected ileum was divided in macroscopically inflamed and fibrotic tissue and single-cell suspensions were made from mucosal and deeper intestinal layers for immune cell characterisation with flow cytometry. For comparison, proximal unaffected CD tissue and control ileum from CRC patients was included. Fibrosis and inflammation were confirmed on HE stained histological sections. Wilcoxon matched-pairs signed-rank test between CD samples and Kruskal–Wallis testing with Dunn’s multiple comparisons test compared with CRC ileum were performed. Results From 12 CD patients, an additional macroscopically inflamed region could be identified next to the fibrotic area, with a decreased fibrosis score as compared with the fibrotic area (4.00 vs. 6.00, p = 0.016) (Figure 1). Both fibrotic and inflamed regions had increased inflammation as compared with proximal unaffected CD and control non-IBD ileum (score: 4.00 and 4.50 vs. 1.00 and 0.00, p &amp;lt; 0.001 for all). In the inflamed ileum, no differences in immune populations were observed between mucosa and deeper layers, reflecting the transmural nature of CD. In contrast, CD19+ B cells were specifically enriched in the mucosa of fibrotic ileum, as compared with proximal CD mucosa (32.20 vs. 20.40% of CD45+ cells, p = 0.008) (Figure 2). In the deeper layers of fibrostenotic CD ileum FcεR+ Siglec 8+ eosinophils (1.13 vs. 1.17 % of CD45+ cells, p = 0.027), mature CD11c+ dendritic cells (3.95 vs. 2.96 % of CD45+ cells, p = 0.042) and M2 CD206+ macrophages (0.35 vs. 0.18% of CD45+ cells, p &amp;lt; 0.001) were enriched as compared with the mucosa overlying the fibrotic tissue (Figure 3). Conclusion These results argue that inflammation in the deeper intestinal layers is different from the inflammatory signature seen in mucosal inflamed regions. We here report alternative innate immune cells expanded specifically in the deeper intestinal layers of fibrostenotic CD ileum that could identify targets for new anti-fibrotic therapies.

Uncoupled inflammatory, proliferative, and cytoskeletal responses in senescent human gingival fibroblasts.

Aging is characterized by a decline in tissue structure and function that may be explained by the development of cellular senescence. However, the acquisition of specific phenotypic responses in senescent gingival fibroblasts is still poorly understood. Here, we have analyzed whether proliferation of primary cultures of human gingival fibroblasts may affect different cell functions relevant to cellular senescence and tissue deterioration. Human gingival fibroblasts from five young donors were expanded until cellular senescence was achieved. Cellular senescence was evaluated by determining modifications in cell size, cell proliferation, p16 and p21 mRNA levels, H2Ax phosphorylation, cell viability, and senescence-associated beta-galactosidase staining. Inflammation was evaluated by analyzing the secretion of cytokines and nuclear translocation of NF-κB. Collagen remodeling was evaluated using a collagen gel contraction assay. Immunofluorescence and confocal microscopy were used to determine changes in the localization of the cytoskeletal proteins. Data analysis was performed to identify changes between cultures of the same donor at early and late passages using the paired sample t test or the Wilcoxon matched-pairs signed-rank test. Late passage cells showed changes compatible with cellular senescence that included increased cell size, reduced cell proliferation, staining for SA-beta gal, phosphorylated H2Ax, and increased p16 and p21 mRNA levels. Late passage cells showed a decrease in collagen contraction and reduced co-localization between the cytoskeletal proteins actin and vinculin. Importantly, late passage cells neither demonstrated changes in the secretion of inflammatory cytokines nor NF-κB activation. Our results imply that cytoskeletal changes and inhibition of cell proliferation represent early modifications in the structure and function of senescent gingival fibroblasts that are not coupled with the acquisition of an inflammatory phenotype. Further studies are needed to clarify the impact of different senescence stages during aging of the periodontium.

Unilateral Orbital Emphysema Secondary to Vitreoretinal Surgery

To describe preoperative, intraoperative, and postoperative characteristics, imaging findings, and clinical evolution of patients who developed orbital emphysema after vitreoretinal surgery. Retrospective, descriptive, observational case series. Patients with orbital emphysema after vitreoretinal surgery who were diagnosed and treated between January 2006 and October 2018 at a single ophthalmology referral center. Medical records and orbital computed tomography images were reviewed and analyzed. A minimum follow-up of 3 months was required. Final best-corrected visual acuity (BCVA). This study included 16 patients with a mean age of 47.9 ± 14.7 years, 50% were women, and 25% had a history of previous ocular trauma. A diagnosis of rhegmatogenous retinal detachment was established in 75% of patients. Twenty-five percent of patients underwent pars plana vitrectomy (PPV), 50% underwent encircling scleral buckling plus PPV, 18.8% underwent repeat PPV, and 6.2% underwent scleral buckling plus repeat PPV. Additionally, 62.5% received silicone oil endotamponade. The median time between vitreoretinal surgery and orbital emphysema was 8 days (interquartile range [IQR] 5-15 days). Mean proptosis was 6.7 ± 4.6 mm. Orbital cellulitis was considered as a differential diagnosis in 31.2% of patients, and tomographic evidence of fracture was observed in 25% of patients. Treatment with compressive patching was prescribed for 87.5% of patients, transpalpebral drainage was prescribed for 75% of patients, hyperbaric oxygen therapy was prescribed for 43.8% of patients, and surgical management was prescribed for 31.2% of patients. The comparison between BCVA before vitreoretinal surgery (median, 1.8 logarithm of the minimum angle of resolution [logMAR]; IQR, 1.33-2.3 logMAR) and at the last follow-up (median, 2.3 logMAR; IQR, 1.42-2.8 logMAR) was not statistically significant (P= 0.125, Wilcoxon matched-pairs signed-rank test). No association was found between surgeon experience and lower final BCVA (P= 0.604, Fisher exact test); however, development of ocular hypertension was associated with worse final BCVA (P= 0.0101; relative risk, 7; 95% confidence interval, 1.01-44.63). Although orbital emphysema constitutes a very unusual complication of vitreoretinal surgery, it is important to identify this condition promptly and treat patients efficiently to avoid potential vision loss.

T2WI female pelvic MRI using the MultiVane XD technique at 3.0 T in uterine adenomyosis and fibroids: a preliminary study

Objective To explore the application value of 3.0 T MultiVane XD (MVXD) technique in female patients with uterine adenomyosis and fibroids. Methods Patients diagnosed with uterine fibroids with ultrasound and suspected of adenomyosis were involved prospectively from March to May 2018, 3.0 T pelvic MRI examinations were performed during peri-ovulatory period. Axialconventional turbo spin echo (TSE) T2WI, axial MVXD T2WI, sagittal conventional TSE T2WI and MVXD sagittal T2WI were acquired. Two observers rated those 4 series in the aspects of sharpness of uterine border, motion artifacts, identification capability of lesions, confidence of diagnosis and overall image quality. Cohen Kappa analysis was used to evaluate the consistency of scores between 2 observers. Scores of TSE T2WI and MVXD T2WI qualities were compared using Wilcoxon matched-pairs signed-ranks test. Results Twenty patients were enrolled. Axial conventional TSE T2WI, axial MVXD T2WI were aquired on all of them. Sagittal conventional TSE T2WI, sagittal MVXD T2WI were aquired on 19 among them. Nine patients had only obvious adenomyosis, 6 had only uterinefibroids, and 5 had adenomyosis and uterine fibroids. Compared to conventional TSE technique, scores of two observers in the sharpness of uterine border, motion artifacts, and overall image quality is higher by MVXD with significant difference (P<0.05). The Kappa values for image quality scores of two observers ranged from 0.615 to 0.971, the agreement was good or very good. Conclusion Applying MVXD T2WI technique to patients with uterine fibroids and adenomyosiscould improve image quality, without sacrificing the ability to recognize and diagnose lesions, compared to conventional TSE T2WI technique. Key words: Adenomyosis; Uterine fibroids; Magnetic resonance imaging; MultiVane XD technique

On-site clinical mentoring as a maternal and new-born care quality improvement method: evidence from a nurse cohort study in Nepal

BackgroundWe describe an on-site clinical mentoring program aimed at improving emergency obstetrical and new-born care (EmONC) in Nepal and assess its effectiveness on nurses’ knowledge and skills. In Nepal, both the maternal mortality ratio (MMR, 239/100,000 live births) and the neonatal mortality rate (NMR, 21/1000 live births) were among the highest in the world in 2016, despite impressive progress over recent decades considering the challenging environment.MethodsFrom September 2016 to April 2018, three experienced nurses conducted repeated mentoring visits in 61 comprehensive or basic EmONC centers and birthing centers located in 4 provinces of Nepal. Using updated national training manuals and teaching aids, these clinical mentors assessed and taught 12 core EmONC clinical skills to their nurse-mentees. Clinical mentors worked with management mentors whose goal was to improve the nurses’ working environment. We assessed whether the cohort of nurse-mentees performed better as a group and individually performed better at the end of the program than at baseline using relevant tests (chi-square test, Wilcoxon matched-pairs signed-rank test, and Kruskal-Wallis equality-of-population rank test).ResultsIn total, 308 nurses were assessed, including 96 (31.2%), 77 (25.0%) and 135 (43.8%) who participated in all three, two or only one mentoring session, respectively. In total, 225 (73.0%) worked as auxiliary nurse-midwives (ANMs), while 69 (22.4%) worked as nurses. One hundred and ninety five (63.3%) were trained as skilled birth attendants, of which 45 (23.1%) were nurses, 141 (72.3%) were auxiliaries and 9 (4.6%) had other positions. The proportion of ANMs and nurse-mentees who obtained a knowledge assessment score ≥ 85% increased from 57.8 to 86.1% (p < 0.001). Clinical assessment scores increased significantly for each participant, and therefore for the group. SBA-trained mentees had better knowledge of maternal and new-born care and were better able to perform the 12 core clinical skills throughout the program.ConclusionsOur study suggests that on-site clinical mentoring of nurses coupled with health facility management mentoring can improve nurses’ clinical competences in and performance of maternity and new-born care. Assessing evidence of impact on patient safety would be the next stage in evaluating this promising intervention.

Effect of panretinal photocoagulation on optic nerve head blood flow with OCT angiography in patients with diabetic retinopathy.

Objective:To investigate the effect of pan retinal photocoagulation (PRP) on Optic nerve head blood flow with OCT angiography in patients with proliferative diabetic retinopathy.Methods:This prospective interventional study was conducted at Eye Unit III, Institute of Ophthalmology, Mayo Hospital, Lahore, over a period of seven months i.e. from 10th May 2019 to 10th November 2019. Thirty-five patients having proliferative diabetic retinopathy were included in this study. Ocular blood flow was measured with OCT Angiography, then pan retinal photocoagulation was performed and patients were called for follow-up after one month and ocular blood flow was measured again with OCT Angiography. The difference in the blood flow was calculated. Frequencies and percentages were calculated for the categorical data and mean and standard deviations were calculated for the continuous data. Wilcoxon matched-pairs signed rank test was performed and effects of PRP on blood flow were compared. Significance level was taken as p≤0.05.Results:Out of 35 patients, 30 patients (85.71%) had decreased post PRP blood flow, four patients (11.43%) had increased post PRP blood flow and one patient (2.86%) did not have any effect.Conclusion:OCT angiography revealed there is significantly reduced optic nerve head blood flow in PRP treated eyes compared to non-PRP treated eyes.

Sugar content of yogurt products in the UK: A comparison between 2016 and 2019

AbstractYogurt is a staple part of children's diets and is perceived as a nutrient dense food for adults and children. However, yogurts are also a significant source of free sugars for children and are a target of the UK government's sugar reduction programme, which has recommended a 20% reduction in the sugar content of yogurt and fromage frais products by 2020. With this in mind, in November 2016, we undertook a comprehensive survey of the nutrient contents of yogurt products in UK supermarkets (Moore et al. 2018). The aim of this work was to reassess the UK supermarkets yogurt products in 2019 and determine whether the sugar contents of yogurt products have been reduced. Product data was collected from the UK's top five online supermarkets in January 2019 using the search terms ‘yogurt’ and ‘yoghurt’. Products were placed systematically into the same 8 categories used in 2016: children's, drinks, dairy alternatives, organic, natural/Greek, fruit, flavoured, desserts. Products lists were collected, refined and compared to the 2016 database. All data was double-checked independently and 5% of all entries were randomly selected and verified. GraphPad Prism V/7.0c was used for statistical analysis. After de-duplication of products found in multiple supermarkets, the 2019 database contained 893 unique products in line with the 898 surveyed in 2016. Of these, 539 (60.4%) yogurts were in common (same brand and name) with the 2016 products and 354 were new, demonstrating dynamic turnover in available yogurt products during the 26 months between surveys. In comparing the total sugar contents of the 539 paired products, notably the median [range] of total sugar contents in 2019 was significantly lower than in 2016 (10.8g/100 g [0.4, 29.5] versus 11.8g/100 g [0.1, 31.8]; P &lt; 0.0001, Wilcoxon matched-pairs signed rank test). Indeed, when all products were compared there was a significant reduction in the median total sugar in 2019 compared to 2016 (10.4g/100 g [0–32.9] versus 11.9g/100 g [0.1–32.6]; P &lt; 0.0001, Mann-Whitney test). Categories showing the most improvements were children's, drinks and fruit yogurts. Fifteen percent of the 2019 products contained less than or equal to 5g/100 g sugars, considered a ‘low sugar’ product, an improvement over the 9% identified in 2016. We conclude the sugar content of UK yogurt products has reduced since the sugar reduction program was put into place in 2016. However, a larger reduction in most categories is needed in order to reach the required 20% reduction by 2020.

Management of Enteral Nutrition in the Pediatric Intensive Care Unit: Prokinetic Effects of Amoxicillin/Clavulanate in Real Life Conditions.

PurposeMalnutrition is a common feature in critically ill children. Enteral nutrition (EN) is the main strategy to nutritionally support critical ill children, but its use can be hindered by the development of intolerance. The study aimed to assess the effectiveness and safety of amoxicillin/clavulanate (A/C) to treat EN intolerance.MethodsWe retrospectively evaluated patients admitted to the pediatric intensive care unit from October 2018 to October 2019. We conducted a case-control study: in the first 6 months (October 2018-April 2019) we implemented the nutritional protocol of our Institution with no drug, whereas in the second half (May 2019-October 2019) we employed A/C for 1 week at a dose of 10 mg/kg twice daily.ResultsTwelve cases were compared with 12 controls. At the final evaluation, enteral intake was significantly higher than that at baseline in the cases (from 2.1±3.7 to 66.1±27.4% of requirement, p=0.0001 by Wilcoxon matched-pairs signed rank test) but not in the controls (from 0.2±0.8 to 6.0±14.1% of the requirement, p=NS). Final gastric residual volume at the end of the observation was significantly lower in the cases than in the controls (p=0.0398). The drug was well tolerated as shown by the similar safety outcomes in both cases and controls.ConclusionMalnutrition exposes critically ill children to several complications that affect the severity of disease course, length of stay, and mortality; all may be prevented by early EN. The development of intolerance to EN could be addressed with the use of A/C. Future prospective clinical trials are needed to confirm these conclusions.

541 Turning novices into experts: can artificial intelligence transform echocardiography training?

Abstract Funding Acknowledgements Philips BACKGROUND Developing new training tools for TransThoracic Echocardiography (TTE) is more important than ever, as the use of ultrasound expands with the advent of mobile devices, both reducing costs and increasing the number of sites and operators. Two major challenges are the lack of experts to meet the growing demand for training and the risk of unnecessary examinations and misdiagnosis by users who lack proper training. PURPOSE To evaluate Artificial Intelligence (AI)-assisted TTE for assessing and improving novices" echocardiography skills. METHODS AI-assisted TTE relies on real-time analysis of the ultrasound stream by AI algorithms (e.g. for automated view recognition) to provide adaptive feedback to the user. It was compared to standard TTE in a prospective study including 40 medical students with no prior ultrasound experience ("novices") and 40 healthy volunteers of varying echogenicity. Novices received a standardized 10-minute presentation of the basic machine controls and requirements of an apical 4-chamber (AP4) acquisition. They were then asked to perform three consecutive AP4 acquisitions on a randomly assigned healthy volunteer: 1) "initial" standard TTE, 2) AI-assisted TTE and 3) "repetition" standard TTE, with a maximum of 3 minutes per acquisition. Additionally, for reference purposes, an AP4 acquisition was performed by an expert. Both the performance over time and the final acquisition performance were assessed by an AI-based AP4 quality score and expressed relatively to the reference score. The suitability for clinical use was assessed by an expert on a 0-3 semi-quantitative scale. RESULTS Kaplan-Meier analysis of the probability to match reference performance over time (see left part in figure below) validated the positive and significant contribution of AI-assisted TTE wrt initial TTE (median time = 16.1s vs. 45.7s, p = 0.026). There was also a positive, though non-significant, contribution wrt repetition TTE (median time = 25.7s, p = 0.20), while the difference between standard TTEs was non-significant (p = 0.24). A majority of novices (70%, resp. 72.5%) improved their final acquisition with AI-assisted TTE wrt initial TTE, resp. repetition TTE. The final performance gain (81.7 ± 29.7% vs. 60.8 ± 40.4%, resp. 70.4 ± 33.9%, see right part in figure below) was shown to be significant by Wilcoxon matched-pair signed-rank test (p &amp;lt; 0.001, resp. p = 0.003). There was no significant difference between standard TTEs (p = 0.34). AI-assisted TTE was also associated with improved suitability for clinical use (2.53 ± 0.79 vs. 2.00 ± 1.03, resp. 2.08 ± 0.98). Among these acquisitions, 50% were found fully suitable for clinical use (vs. 22.5%, resp. 27.5%). CONCLUSION AI-assisted TTE can assess and improve novices" echocardiography skills. Developing and embedding AI-assistance in ultrasound devices could be a cost-effective way to support the training of novices and key to acquisition standardization. Abstract 541 Figure.

Effects of Intensive Phase Antituberculous Therapy on Hepatic and Haematological Parameters in Patients at the University Teaching Hospital in Lusaka, Zambia

Objectives and study design: Zambia is a high tuberculosis burden country. Antituberculous medicines are the mainstay of tuberculosis management. There have been several reports of antituberculous drug-related haematological and hepatic adverse effects noted in other settings. Adverse events have healthcare cost and morbidity implications. Prevalence and severity of these adverse effects are understudied in patients at University Teaching Hospitals hence the purpose of this study was to identify haematological and hepatic abnormalities and compare parameters before treatment and after completion of the intensive phase among the patients. Factors associated with abnormalities were also determined. A prospective longitudinal study was undertaken at Chest Clinic between April 2018 and July 2018. Study patients were followed up for 2 months. Full blood count and liver function tests were recorded at baseline and at follow-up. Abnormalities were defined according to the 2017 Department of AIDS Table for Grading the Severity of Adult and Paediatric Adverse Events. Data were analysed using SPSS version 22.0. Paired t-test and Wilcoxon matched-pairs signed-rank test were used to compare parameters. Logistic regression was performed to determine factors that were predictive of abnormalities. A p&lt; 0.05 was considered statistically significant. Results: A total of 37 patients were involved in the study. 56.8% of patients were male. The mean age of patients was 36.2 years (19 – 57 years) while body mass index was 21.9 kg/m2. Only 37.8% of patients were sputum smear-positive at baseline. 56.8% of patients had HIV co-infection. 45.9% of patients were on antiretroviral therapy.45.2% of patients had grade 1-3 aspartate transaminase derangements at follow-up compared to 29.7% at baseline. 5.4% of the patients had grade 1-3 alanine transaminase derangements at baseline while 9.7% of patients had grade 1 at follow-up. Fewer patients (16.1%) had grade 1-2 anaemia at follow-up while 62.2% of patients at baseline had grade 1-4 anaemia. More patients (46.2%) had platelet derangements at follow-up compared to 25.8% at baseline. Fewer patients had differential white cell count derangements at follow-up compared to baseline. Statistically significant differences in haematological parameters: haemoglobin concentration, haematocrit, red, and white cell, eosinophil and neutrophil counts at baseline and follow-up were found. However, no statistically significant differences in red cell indices were observed. Changes in alanine transaminase levels at baseline and follow-up were statistically significant. Logistic regression was performed to determine the effects of age, gender, body mass index, HIV infection, antiretroviral therapy, sputum smear status, and appropriate baseline full blood count/liver function test parameters on the likelihood of study patients having deranged haemoglobin concentration, white cell count and alanine transaminase at follow-up. Logistic regression models to predict deranged haemoglobin concentration and white cell count were statistically insignificant. None of the predictor variables were associated with the likelihood of derangements in alanine transaminase. Conclusion: Findings of this study show that haematological and hepatic adverse effects were relatively fewer at follow-up and were mostly grades 1-3 in severity. Antituberculous therapy is relatively safe for patients during the initial phase.

Efficacy of Brimhana Nasya and Ashwagandha (Withania somnifera (L.) Dunal) root powder in primary insomnia in elderly male: A randomized open-label clinical study.

Background:Decreased ability to fall asleep and/or stay asleep with daytime effects of sleep deprivation is identified as primary insomnia. Elderly due to the predominant Vata Dosha in the body are easily affected by this problem. Brimhana Nasya (nourishing nasal drop) with Ksheera Bala Taila and oral administration of Ashwagandha (Withania somnifera (L.) Dunal) root powder both are indicated in Ayurvedic classics for the management of insomnia.Aim:To determine the combined efficacy of oral administration of Ashwagandha root powder along with Brimhana Nasya with Ksheera Bala Taila in primary insomnia in geriatric.Materials and methods:This was randomized, open-label clinical study conducted at the hospital of Pt. Khushilal Sharma Government Ayurveda College and Institute Bhopal. Randomly selected 60 elderly patients with primary insomnia were randomly divided into two groups (30 in each group). Pittsburgh Sleep Quality Index was used to assess the symptoms of primary insomnia. Relief in the subjective symptoms was assessed in percentage. Then, the statistical significance of result within the group was assessed using Wilcoxon matched-pairs signed-ranks test and the comparative effect of therapy in both groups was assessed using Mann-Whitney test. Graph Pad InStat-3 software was used for statistical analysis.Results:On subjective sleep quality 86.66% relief with P < 0.0001, on sleep latency 60.02% improvement with P < 0.0001, improvement in sleep duration was reported in 89.15% of patients with P < 0.0001 and improvement in sleep efficiency was reported in 90.14% of patients with statistically extremely significant P < 0.0001 were observed in combined therapy group (Ksheera Bala Taila Brimhana Nasya along with oral administration of Ashwagandha root powder). While 38.66% improvement in sleep efficiency, 40.39% relief in sleep disturbances and 37.05% improvement on subjective sleep quality was reported in group B patients, i.e., Ashwagandha root powder group.Conclusion:In 30 days treatment combined therapy was found more effective in the management of primary insomnia in the elderly compared with Ashwagandha root powder alone.