Clinical Characteristics Of Study Participants Research Articles

Quality of life in Ghanaian children and adolescents with type 1 diabetes mellitus compared with non diabetic controls and caregivers’ report

Background: Measurement of health-related quality of life (HRQOL) in children and adolescents with type 1 diabetes mellitus (T1DM) is as important as metabolic control in the management and prevention of diabetes-related complications. Aim: To describe the self-reported HRQOL outcomes in Ghanaian children and adolescents with T1DM compared with healthy controls and perceived HRQOL by caregivers. Setting: Out-patient clinics of the Departments of Child Health, Medicine and Therapeutics, Family Medicine, and Ophthalmology, the National Diabetes Management and Research Centre (all at the Korle Bu Teaching Hospital), and the Cape Coast Teaching Hospital (CCTH). Methods: Socio-demographic and clinical characteristics of study participants were documented. Participants completed the PedsQL™ 4.0 Generic Core Scales. Data analysis was done with SPSS Version 25.0. An unpaired t-test was used in comparing the HRQOL scores between children and adolescents with T1DM and controls, and parental proxy reports. Results: Fifty children and adolescents with T1DM, 50 parents/caregivers, and 80 healthy non-diabetic controls took part in this study. There was no significant difference in mean score between the patients and the caregivers for overall HRQOL (p = 0.270). Patients reported significantly worse overall HRQOL than their controls (p = 0.001). Males with diabetes reported better HRQOL than females (p = 0.007). Conclusion: Children and adolescents with T1DM and their parents/caregivers reported lower HRQOL scores compared to healthy controls. Males reported better HRQOL than females. Potential implications: HRQOL should be routinely assessed together with proxy reports from parents to identify those who might benefit from further attention including referral to a psychologist.

Abstract P1-02-03: Real World Treatment Patterns of Adjuvant Endocrine Therapy and Ovarian Suppression in Premenopausal HR+/HER2+ Breast Cancer

Abstract Background: Approximately 10% of breast cancers (BC) are hormone receptor positive (HR+) and HER2 positive (HER2+). Despite treatment advances in the modern era of HER2 targeted therapies for early-stage disease, there remains a risk for late relapses. However, the role of adjuvant endocrine therapy (ET) to reduce recurrence in this BC subtype is unclear. Oncologists employ clinical judgment given lack of consensus, resulting in differences in treatment patterns. The ideal endocrine agent including the role of adding ovarian suppression (OS) in premenopausal women is unknown. These patients are largely underrepresented in clinical trials such as the phase III SOFT and TEXT studies. Additionally, these trials were initiated prior to the widespread use of trastuzumab with chemotherapy, which is now standard of care for HER2+ disease. We aimed to describe real world patterns surrounding choice of adjuvant ET and clinicopathologic features which predicted treatment with OS in premenopausal women with HR+/HER2+ BC. Methods: We performed a multi-institutional retrospective analysis of premenopausal women with non-metastatic HR+/HER2+ BC in the American Society of Clinical Oncology CancerlinQ® Discovery database from January 2010 to May 2020. Electronic health record data was obtained from 74 participating academic and community oncology sites. We collected clinical data on women less than 50 years who received chemotherapy, anti-HER2 therapy (trastuzumab with or without pertuzumab), and ET. Adjuvant OS was defined as receipt of at least 6 months of goserelin or leuprolide or surgical bilateral oophorectomy. Demographics, clinical characteristics, and treatment history was collected. Patients were categorized into 1 of 4 groups based on type of adjuvant ET prescribed at treatment initiation: aromatase inhibitor (AI) + OS, OS, tamoxifen + OS, or tamoxifen. Multivariable logistic regression was conducted to assess the association between clinicopathologic features and OS use. Results: Out of 360,540 patients with invasive breast cancer in the database, 937 met inclusion criteria. Mean age was 41.7 (SD 5.9) years; 83% had stage 1 or 2 BC and 78% had node positive disease. The majority (n=818, 87%) were prescribed tamoxifen whereas only 4 (0.4%), 50 (5.3%), and 65 (6.9%) received OS, tamoxifen + OS, and AI + OS, respectively. Table 1 includes demographic and clinical characteristics of the cohort. No clinicopathologic features predicted OS use apart from age; patients ≥35 years were less likely to receive OS compared with those < 35 (p< 0.001) (table 2). Conclusion: To our knowledge, this is the first real world study evaluating OS treatment in HR+/HER2+ BC. The use of OS was uncommon; this suggests a perception of its limited benefit when added to HER2-targeted therapy. Most patients received tamoxifen as the ET of choice. Age was the only factor to predict OS treatment; high risk features including node positivity and higher stage was not associated with its use. This highlights the wide variability in real world practice surrounding the clinical indications for OS. Further investigation is warranted to characterize the utility of ET including addition of OS to prevent recurrence in premenopausal HR+/HER2+ BC. This will better inform a personalized approach to tailor therapy for optimal outcomes in this distinct BC subtype. Table 1. Demographic and clinical characteristics of study participants by endocrine therapy treatment group. Table 2. Multivariable logistic regression model of clinicopathologic characteristics to predict use of ovarian suppression. Citation Format: Jasmine S. Sukumar, Sagar Sardesai, Andy Ni, Nicole Williams, Bhuvaneswari Ramaswamy, Robert Wesolowski, Mathew A. Cherian, Daniel Stover, Margaret Gatti-Mays, Ashley C. Pariser, Preeti K. Sudheendra, Mridula A. George, maryam lustberg. Real World Treatment Patterns of Adjuvant Endocrine Therapy and Ovarian Suppression in Premenopausal HR+/HER2+ Breast Cancer [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P1-02-03.

Association Between Helicobacter pylori Infection and Anemia Among Adult Dyspeptic Patients Attending Kiryandongo General Hospital, Uganda.

To determine the prevalence of anemia and its association with Helicobacter pylori infection among adult dyspeptic patients. A cross-sectional study was conducted among 283 dyspeptic patients at Kiryandongo General Hospital, in Uganda. A structured questionnaire was administered to capture demographic and clinical characteristics of study participants. Four milliliters of blood were then collected into an EDTA vacutainer for Complete Blood Count (CBC) and analyzed using HUMA COUNT 30TS, and peripheral blood smears were made and stained using Giemsa stain. Anemia was defined as hemoglobin levels <12g/dl in females and <13g/dl in men according to the World Health Organization (WHO).Helicobacter pylori (H. pylori) stool antigen test was performed using Whole power H. pylori Ag rapid test device, and saline stool preparation was examined for intestinal parasites. Chi-squared test and Logistic regression were performed to determine association, and a p-value of ≤0.05 was considered statistically significant. The overall prevalence of Helicobacter pylori infection was 42.4% (120/283). The prevalence of anemia among H. pylori-infected patients was 25.8% (31/120) and 15.3% (25/163) among H. pylori-negative counterparts. H. pylori infection was significantly associated with anemia (p-value 0.042), age (p-value 0.02, 0.009), water sources (p-value 0.0049,) and intestinal parasitic infestation (p-value 0.02), respectively. This study has shown that the prevalence of H. pylori infection and anemia is high among dyspeptic patients at Kiryandongo General Hospital. H. pylori infection was found associated with anemia, age, water sources, and intestinal parasitic infestation. Routine screening of anemia in H. pylori-infected individuals and further studies to explore the relationship between anemia and H. pylori disease is highly recommended.

Progesterone and progesterone-induced blocking factor (PIBF) levels in non-obese women with polycystic ovary syndrome

Purpose: This study aimed to evaluate the level of progesterone and progesterone-induced blocking factor (PIBF), an immune mediator, in non-obese patients with polycystic ovary syndrome (PCOS).&#x0D; Materials and Methods: Totally 72 patients were recruited into study and divided into 2 groups: The first group was patients diagnosed with PCOS (n = 36) and the second was the healthy control group (n=36). The diagnosis of PCOS was made according to Rotterdam diagnostic criteria. All patients were 18–35 years old and non-obese (body mass index (BMI) &lt; 25 kg/m2). Follicle-stimulating hormone (FSH), luteinizing hormone (LH), estradiol (E2), thyroid-stimulating hormone (TSH), prolactin (PRL), total testosterone, and dehydroepiandrostenedione sulfate (DHEA-S) levels were measured on the third day of the menstrual cycle. On the 21st day of the same menstrual period, fasting blood glucose, insulin, progesterone, and PIBF levels were measured. &#x0D; Results: Demographic and clinical characteristics of study participants were similar between the two groups. Serum FSH, E2, TSH, PRL, DHEA-S, total testosterone, fasting blood glucose, fasting insulin, homeostatic model assessment for insulin resistance (HOMA-IR), and hemoglobin A1c values were similar between the groups. Differences in LH, LH/FSH ratio, serum progesterone, and serum PIBF were statistically significant.&#x0D; Conclusion: Progesterone and PIBF levels decreased in non-obese PCOS patients. We suggest that even in the absence of obesity, which is the origin and enhancer of inflammation in PCOS, low PIBF as the underlying immunomodulator will drive complications.

Risk stratification and prognostic value of prothrombin time and activated partial thromboplastin time among COVID-19 patients.

BackgroundCOVID-19 is a viral disease caused by a new strain of corona virus. Currently, prognosis and risk stratification of COVID-19 patients is done by the disease’s clinical presentation. Therefore, identifying laboratory biomarkers for disease prognosis and risk stratification of COVID-19 patients is critical for prompt treatment. Therefore, the main objective of this study was to assess the risk stratification and prognostic value of basic coagulation parameters and factors associated with disease severity among COVID-19 patients at the Tibebe Ghion Specialized Hospital, COVID-19 treatment center, Northwest Ethiopia.MethodsA follow-up study was conducted among conveniently recruited COVID-19 patients attended from March to June 2021. Socio-demographic and clinical data were collected using a structured questionnaire and checklist, respectively. Prothrombin time (PT) and activated partial thromboplastin time (APTT) were analyzed by the HUMACLOT DUE PLUS® machine. Descriptive statistics were used to summarize the socio-demographic and clinical characteristics of study participants. Kruskal Wallis tests were used to compare the difference between parametric and non-parametric continuous variables, respectively. The area under the receiver operating characteristic curve (AUC) was used to evaluate the value of PT and APTT in the risk stratification and disease prognosis of COVID-19 patients. Ordinal logistic regression was used to identify the factors associated with disease severity and prognosis. A P-value < 0.05 was defined as statistically significant for all results.ResultBaseline PT at a cut-off value ≥ 16.25 seconds differentiated severe COVID-19 patients from mild and moderate patients (AUC: 0.89, 95% CI: 0.83–0.95). PT also differentiated mild COVID-19 patients from moderate and severe patients at a cut-off value ≤ 15.35 seconds (AUC: 0.90, 95% CI: 0.84–0.96). Moreover, alcohol drinkers were a 3.52 times more likely chance of having severe disease than non-drinkers (95% CI: 1.41–8.81). A one-year increment in age also increased the odds of disease severity by 6% (95% CI: 3–9%). An increment of ≥ 0.65 seconds from the baseline PT predicted poor prognosis (AUC: 0.93, 0.87–0.99).Conclusions and recommendationsProlonged baseline PT was observed in severe COVID-19 patients. Prolonged baseline PT was also predicted to worsen prognosis. An increase from the baseline PT was associated with worsen prognosis. Therefore, PT can be used as a risk stratification and prognostic marker in COVID-19 patients.

MO848PREVALENCE OF COVID -19 IN CHRONIC HEMODIALYSIS PATIENTS AT THE TARIJA DEPARTAMENTAL HEMODIALYSIS CENTER DURING THE PEACK OF THE ANDEMIC JULY - SEPTEMBER 2020

Background and AimsBolivia was the last country to enter in the list of Latin American countries to report cases for the worldwide pandemic of COVID-19, reporting its first two confirmed cases on March 11, 2020 in the cities of Santa Cruz and Oruro. In Tarija department, the peak of cases was registered in the months of July, August and September. The Departmental Hemodialysis Center during this period had 71 registered patients undergoing chronic hemodialysis sessions. In this article we display the prevalence of patients who were infected with COVID-19 during that period of time.MethodThis is a prospective cohort observational study in which 71 patients were observed, who underwent hemodialysis sessions during the three shifts during the day (morning, afternoon and evening, during the months of July, August and September, months which were the peak of the pandemic in Tarija. Patients suspected of being transmitted with the disease, underwent immunochromatography IgM/IgG, ELISA anti SARS-CoV-2 and RT/PCR tests before confirming the diagnosis of COVID-19. Patients who had hemodialysis sessions for a period of less than 3 months were excluded from the study, and also those who changed their treatment modality for peritoneal dialysis to hemodialysis.Results63 patients, 27 men and 36 women, who underwent hemodialysis sessions during the observational period met the inclusion criteria of the study. 7 patients were excluded for not meeting the inclusion criteria, 6 with a period less than 3 months undergoing hemodialysis and 1 patient who had changed the treatment modality from peritoneal dialysis to HD were excluded too. Of the 63 hemodialysis patients, 57 patients remained healthy and 6 were diagnosed with COVID-19 (Table 1). The prevalence of patients who presented COVID-19 in the hemodialysis center was 9%, with 33% of mortality and 83% who were able to recover and receive epidemiological discharge (figure 1). Of the 6 patients who developed COVID-19, 3 were women and 3 were men, 4 patients with previous hepatitis B infection who were dialyzed in the room with machines HBV + and 2 patients without liver infections who were dialyzed in negative machines. Three patients evolved asymptomatic during the SARS-CoV-2 infection, 2 presented thermal rises and mild cough, but without compromise in O2 saturation or ventilatory function, and one patient who died developed mild cough, slight fever and a hemodialysis catheter-related bloodstream infection by Staphylococcus aureus, confirmed in blood culture.Clinical characteristics of study participants (N=63)COVID negative N= 57COVID positive N= 6All patients N= 63AgeMean51.0857,651.66Gender F (m)%58(42)50(50)57(43)EthnicityLatin%9810098Black%202Reason of HDDiabetes nephropaty%355036Hypertensive nephropaty%25022GMN%265029PKD%505Other%908Vintage on HD (m)mean29 (3-108)12 ( 6-18)(3-108)ConclusionThe prevalence of patients infected by SARS-CoV-2 was 9% with a mortality of 17% (1 patient), validating that strict patient control and prevention measures become a great support to avoid massive spread between patient prone to acquire this infectious disease.

Polysomnography parameters as predictors of respiratory adverse events following adenotonsillectomy in children

The first-line treatment of obstructive sleep apnea syndrome in children is adenotonsillectomy, but this may result in perioperative respiratory adverse events (PRAEs). The primary aim of this study is to examine whether the McGill oximetry score (MOS) and other polysomnography parameters can predict major PRAEs following adenotonsillectomy. We secondarily evaluated the MOS interrater reliability and correlation with other polysomnography parameters. This retrospective study included all children aged 0-18 years who underwent preoperative polysomnography between June 2010 and January 2016 prior to adenotonsillectomy at a tertiary pediatric institution. Oximetries from polysomnograms were assigned an MOS. Univariable and multivariable models for prediction of major PRAEs were constructed. MOS was correlated with polysomnography parameters and interrater reliability was evaluated. This study included 106 children; 15 had a major PRAE. A multivariable prediction model that combined MOS and age showed evidence for the ability to predict major PRAEs with an area under the receiver operating characteristic curve of 0.68 (95% confidence interval: 0.52, 0.84), whereby increased MOS and younger age were associated with PRAEs, but apnea-hypopnea index was not. MOS had excellent interrater reliability (κ = 0.95) and was highly correlated with oxygen saturation nadir and cumulative time percentage with oxygen saturation less than 90%. A prediction model including MOS and age may predict PRAEs following adenotonsillectomy. This suggests that nocturnal oximetry provides the most essential information of polysomnography measures to direct postoperative monitoring following adenotonsillectomy. Xiao L, Barrowman N, Momoli F, etal. Polysomnography parameters as predictors of respiratory adverse events following adenotonsillectomy in children. J Clin Sleep Med. 2021;17(11):2215-2223.

Age and gender characteristics of thoracic aorta elasticity indices in patients with coronary atherosclerosis

Background. Ischemic heart disease (CHD) holds a leading position in the structure of causes of general mortality and in the structure of mortality from cardiovascular diseases. We extended the standard echocardiography with assessment of thoracic aorta elasticity to identify markers of the thoracic aorta elasticity worsen associated with coronary atherosclerosis. When analyzing the data, we identified different clinical characteristics of study participants as one of the main reasons for the difficulty in comparing the data with the results of previous studies, which made it necessary to highlight age and gender characteristics of indicators.Aim. To analyze age and gender characteristics of thoracic aorta elasticity indices in patients with coronary atherosclerosis.Material and methods. An observational analytical cross- sectional clinical trial was conducted from 2016 to 2019. Our study included 109 patients aged 39 to 82 years (mean age 65 ± 9 years, median 66 years), who were divided into 2 groups according to the results of invasive coronarography: 64 patients with coronary atherosclerosis and 45 patients without angiographic signs of coronary atherosclerosis. In the group with coronary atherosclerosis average age was 66 ± 8 years (median 66 years). In the group without coronary atherosclerosis average age was 64 ± 9 years (median 66 years). During transthoracic echocardiography, the following were obtained: coefficient of distensibility, compliance coefficient, elasticity (stiffness) module of Peterson, stiffness index of the ascending thoracic aorta; systolic velocity S, early diastolic velocity E, late diastolic velocity A of the near wall of the ascending aorta, flow velocity propagation (FVP) of the descending thoracic. Analysis of age and gender characteristics of thoracic aorta elasticity indices in patients with coronary atherosclerosis was done.Results. An increase in the stiffness index of the ascending thoracic aorta associated with coronary atherosclerosis occurs in the age group 39–66 years, a decrease in the coefficients of extensibility and compliance, an increase in Peterson’s modulus of elasticity (stiffness) of the as cending thoracic aorta — in the age group 67–82 years. A decrease in the E velocity of the near wall of the ascending thoracic aorta and FVP, associated with coronary atherosclerosis, occurs regardless of belonging to the age group, a decrease in the S velocity — in the age group 39–66 years. A decrease in the compliance coefficient of the ascending thoracic aorta, velocity S of the near wall of the ascending thoracic aorta, associated with coronary atherosclerosis, occurs only in men, an increase in the stiffness index — only in women. A decrease in the extensibility coefficient, an increase in the Peterson’s modulus of elasticity (stiffness), a decrease in the E velocity, and a decrease in CRP associated with coronary atherosclerosis occur regardless of gender.Conclusion. Worsening of the thoracic aorta elasticity in patients with coronary atherosclerosis, assessed using echocardiographic technologies, depends on gender and age.

Evaluation of Warfarin Anticoagulation at University of Gondar Comprehensive Specialized Hospital, North-West Ethiopia.

PurposeTo assess the quality of warfarin anticoagulation and its clinical outcomes on patients treated with warfarin at the University of Gondar comprehensive specialized hospital, North-west Ethiopia.MethodsWe reviewed medical records of patients treated with warfarin between June 1, 2016, and May 30, 2018, at the University of Gondar comprehensive specialized hospital. The quality of anticoagulation was evaluated using the percentage of time spent in the therapeutic range. Data were entered into Statistical Product and Service Solutions (SPSS), version 20. Descriptive statistics were used to describe the socio-demographic and clinical characteristics of study participants. Multivariable logistic regression analysis was performed to identify independent predictors of quality of anticoagulation. Statistical significance was declared when the p-value was less than 0.05 at 95% confidence interval (CI).ResultsFrom a total of 202 patients’ charts reviewed, women accounted for 134 (67.3%). The mean participants’ age was 44.33 years (±17.05years SD). The median time spent in the therapeutic range was 37.91 with an IQR of (0.00–65.86). More than two-third (143, (70.8%)) of participants had poor anticoagulation quality (time spent in the therapeutic range is less than 65%). Twenty-seven patients (13.4%) experienced adverse medication events of bleeding and thromboembolic events. Logistic regression analysis showed that potential medication interaction [p= 0.003 95% CI Adjusted odds ratio (AOR): 0.32 (0.152–0.689)] and presence of co-morbidity [p= 0.037 95% CI AOR: 0.70 (1.046–4.105)] were significantly associated with quality of anticoagulation.ConclusionThe quality of warfarin anticoagulation at the University of Gondar comprehensive specialized hospital was poor. A strong effort is needed to improve the quality of anticoagulation. Patients who had other co-morbidity conditions and potentially interacting medication need special attention.

Antiretroviral therapy in community pharmacies - Implementation and outcomes of a differentiated drug delivery model in Nigeria

The World Health Organization recommended differentiated models of care portends opportunities to decongest hospitals providing antiretroviral therapy (ART) and improve retention, especially in developing countries. A community pharmacy-based ART refill model was implemented where stable clients were devolved to community pharmacies for routine refills at a service fee, to promote private sector participation and sustainability of ART services. The aim of this study was to assess the feasibility, acceptability and outcomes of this model in Nigeria. A population-based retrospective analysis of the community pharmacy ART refill program of the United States Agency for International Development-funded 'Strengthening Integrated Delivery of HIV/AIDS Services' project in Lagos, Rivers, Cross River and Akwa Ibom States from October 2016 to February 2018 was conducted. Standard descriptive statistical methods were used for baseline demographic and clinical characteristics of study participants. Outcomes were assessed using the Chi-square test and a multivariate logistic regressions model. Statistical significance was defined at α-level of 0.05. Analyses were performed using SPSS for Windows version 23 (IBM Corp, Armonk, USA). A total of 10015 participants representing 14.4% of ART clients in 50 hospitals opted for this model and were devolved to 244 community pharmacies. All clients consented and paid a service fee of N1000 (about $3) per refill visit. Median follow-up duration was 6 months. Prescription refill rate was 95% (95% CI 94.2-95.3). Retention rate was 98% while viral suppression was 99.12%. Refill rates were significantly affected by ART duration, regimen, age and location (P<0.001, 0.004, 0.034 and<0.001 respectively). This community pharmacy ART refill model of differentiated care is feasible and acceptable by clients and providers and demonstrated excellent clinical outcomes of retention and viral suppression. The ability and willingness of some clients to contribute financially to their HIV care was also demonstrated.

Clinical Features of COVID-19 in Uzbekistan.

BackgroundAs of April 30, 2020, a total of 2,039 cases of the novel coronavirus disease 2019 (COVID-19) were confirmed in the Republic of Uzbekistan after the first detection on March 15. Reports on symptoms of COVID-19 are non-specific and known to vary from asymptomatic, mild to severe, or fatal. This study aimed to analyze the symptomatic and clinical characteristics of study participants based on the medical records of participants hospitalized with COVID-19 in Uzbekistan.MethodsWe collected all data from medical records of COVID-19 confirmed patients in 19 hospitals from 13 regions of Uzbekistan between March 15 and April 30. We selected 1,030 patients discharged from the hospitals after COVID-19 treatment as study participants, excluding those with missing data. Further, we collected demographics, symptoms, clinical outcomes, and treatment data through medical records.ResultsMore than half (57.6%) of confirmed cases of COVID-19 were males, and the median age was 36.0 years. The most frequent symptoms at the first inspection on hospital admission of all patients were fatigue (59.7%), dry cough (54.1%), pharyngalgia (31.6%), headache (20.6%), and anorexia (12.5%). Compared to the oldest group, the youngest group showed a lower frequency of symptoms. About half of the group aged 18–49 years reported that they came from abroad. One-fifth of patients in group 50–84 received oxygen support, while no patients in group aged 0–17 years received oxygen support. About two-thirds of the participants from intensive care unit (ICU) came from abroad, whereas 42.1% of the non-ICU group returned from other countries. Regarding symptoms, 16.9% of the patients in the ICU group were asymptomatic, while 5.8% in the non-ICU group were asymptomatic.ConclusionThis study suggests that the medical delivery system and resource distribution need to be implemented based on clinical characteristics by age and severity to delay and effectively respond to the spread of infections in the future. This study analyzed symptoms of COVID-19 patients across Uzbekistan, which is useful as primary data for policies on COVID-19 in Uzbekistan.

Peculiarities of sleep problems in multiple sclerosis

Background and objectiveRecent research indicates that sleep problems are common in persons with relapsing-remitting multiple sclerosis (RRMS), however, the relation between sleep problems and socio-demographic and clinical characteristics of patients with RRMS has not yet been investigated systematically. The objective of our study was to investigate the relations between sleep problems and social and clinical peculiarities in RRMS patients. Material and methods18–74 years old individuals with RRMS (N=101) involved in an ongoing self-report survey study were asked to complete the Medical Outcomes Study Sleep (MOSS) Scale, Fatigue Severity Scale (FSS), Numerical Rating Scale (NRS) for pain, Visual Analoque Scale (VAS) for bladder/sexual dysfunction, and Hospital Anxiety and Depression scale. Multiple regression was used to evaluate relations between sleep problems and socio-demographic and clinical characteristics of study participants. ResultsThe mean sleep problems score on the MOSS scale was 39.22 and 54.5% of the sample had sleep problems. In a regression model variables statistically significantly related with sleep problems included female sex, older age, higher level of disability, fatique, pain, bladder/sexual dysfunction, depression and anxiety. ConclusionThe sleep problems were highly prevalent in RRMS patients and related with some of the socio-demographic and clinical characteristics.

Allopurinol treatment improves renal function in patients with type 2 diabetes and asymptomatic hyperuricemia: 3-year randomized parallel-controlled study.

To investigate the effects of long-term effective control of serum uric acid on renal function in patients with type 2 diabetes and asymptomatic hyperuricemia. Application of randomized open parallel-controlled methods, a total of 176 patients with type 2 diabetes and asymptomatic hyperuricemia were selected, and was randomly divided into two groups for allopurinol or conventional treatments, respectively. Changes in urinary albumin excretion rate (UAER), the levels of serum creatinine and glomerular filtration rate (GFR) and the incidence of new-onset diabetic nephropathy (DN) and hypertension in patients before and after 3years of treatment were measured and compared between groups. There were no statistically significant difference in the baseline clinical characteristics of study participants between two treatment groups (P>0·05 for all). After 3years of treatment, compared to the conventional treatment, the allopurinol treatment was more effective in reducing serum uric acid, UAER, serum creatinine (P<0·01 for all) and increasing GFR (P<0·01). The intention-to-treat (ITT) analysis indicated that the incidence of new-onset DN and hypertension in the allopurinol group showed a declining trend compared to that in the conventional treatment group, despite a lack of significant difference (P>0·05). Long-term effective control of serum uric acid can decrease UAER and serum creatinine, increase GFR and may exert kidney protection effects in patients with type 2 diabetes and asymptomatic hyperuricemia.

Predictors of accessing antiretroviral therapy among HIV-positive drug users in China's National Methadone Maintenance Treatment Programme.

The objective of this study was to examine factors that predict antiretroviral therapy (ART) access among eligible, HIV-positive methadone maintenance treatment (MMT) clients. We also tested the hypothesis that sustained MMT participation increases the likelihood of accessing ART. A nation-wide cohort study conducted from 1 March 2004 to 31 December 2011. MMT clients were followed from the time of their enrolment in China's national MMT programme until their death or the study end date. Our cohort comprised 7111 ART-eligible, HIV-positive MMT clients, 49.2% of whom remained ART-naive and 50.8% of whom received ART. Demographic variables, drug use history, MMT programme participation and HIV-related clinical characteristics of study participants who remained naive to ART and those who accessed ART were compared by univariate and multivariable analysis. Predictors of accessing ART among this cohort included being retained in MMT at the time of first meeting ART eligibility [adjusted odds ratio (AOR)=1.84, confidence interval (CI)=1.54-2.21, P<0.001] compared to meeting ART eligibility before entering MMT (AOR=0.98, CI=0.80-1.21, P=0.849) or previously entering MMT and dropping out before meeting ART eligibility. Additional predictors were CD4≤200 cells/μl when ART-eligibility requirement was first met (AOR=1.81, CI=1.61-2.05, P<0.001 compared to CD4=201-350 cells/μl), and being in a stable partner relationship (married/cohabitating: AOR=1.14, CI=1.01-1.28, P=0.030). Retained participation in methadone maintenance treatment increases the likelihood that eligible clients will access antiretroviral therapy. These results highlight the potential benefit of colocalization of methadone maintenance treatment and antiretroviral therapy services in a 'one-stop-shop' model.

Snoring, Daytime Sleepiness, and Incident Cardiovascular Disease in The Health, Aging, and Body Composition Study

To examine the association between snoring and incident cardiovascular disease (CVD). This is a prospective study in which community dwelling older adults were evaluated at baseline, and followed up for an average of 9.9 years. Data on snoring, daytime sleepiness, as well as demographic and clinical characteristics of study participants was collected at baseline, and participants were followed up every six months for an average of 9.9 years. Based on snoring and sleepiness status, 4 groups of participants were created: (1) No Snoring, No Sleepiness; (2) No Snoring, Sleepiness; (3) Snoring, No Sleepiness; (4) Snoring, Sleepiness. Incident CVD was defined as a diagnosis of myocardial infarction, angina pectoris, or congestive heart failure that resulted in overnight hospitalization during the follow-up period. Cox proportional hazard was used to estimate the risk of incident cardiovascular disease during follow-up by baseline snoring and sleepiness status. A total of 2,320 participants with a mean age of 73.6 (2.9) years at baseline were included in the analysis. Fifty-two percent were women, and 58% were white. A total of 543 participants developed CVD events during the follow-up period. Participants who reported snoring associated with daytime sleepiness had significantly increased hazard ratio for CVD events (HR = 1.46 [1.03-2.08], P = 0.035) after adjusting for demographic and clinical confounding factors. The results suggest that self-reported snoring and daytime sleepiness status are associated with an increased risk of future cardiovascular disease among older adults.

Self-Reported Sleep Problems Across the Ages-An Intercontinental Study

Background: The pattern of associations among aging, sleep complaints and health status have been described among older adults from high-income countries living in temperate climate. However, demographic and clinical correlates of sleep problems among the elderly in non-affluent countries have not been previously reported. Objectives: To describe the relationship between age and sleep problems among adults living in 5 middle income countries in Africa, Asia and North America, and evaluate the impact of clinical characteristics of study participants on the association between age and sleep problems. Measurements: Demographic and clinical characteristics which include age, gender, household income, selfreported sleep problems, pain, depression, breathing difficulty, memory problems, blood pressure, weight, height, gait speed, self-reported health status and quality of life. Results: Data was available for a total of 37,822 participants from the 5 countries. Sleep problems were more commonly reported among older adults, participants with symptoms of pain, depression, breathing difficulty, memory problems, and those with low walking speed. In multivariable logistic regression analysis, the association between age and sleep problems were considerably attenuated after adjusting for clinical characteristics of study participants. Conclusion: Results of this study suggest that the increased prevalence of sleep problems among older adults may be due to associated poor health status rather than the age of participants, regardless of ethnic origin and cultural background of study participants, or the geography of their place of residence. These findings would have important implications for the management of sleep problems as well as chronic diseases among older adults.

Continued Transmission of Parvovirus B19 in Plasma-Derived Factor Concentrates After the Implementation of B19 Nucleic Acid Plasma Minipool Screening,

Abstract 3378 Background:Parvovirus B19 (B19) is a small, non-enveloped virus that causes a typically benign flu-like illness most commonly in childhood. However, B19 has been associated with arthritis and poses a hazard to the fetus of a pregnant woman. Because infection is common and viremia can occur before symptoms develop, about 1% of blood donations can be contaminated with B19 virus. The virus is resistant to current viral inactivation steps used in the manufacture of plasma-derived (P-D) anti-hemophilic factor concentrates and B19 transmission through these products has been documented. Since 2000, manufacturers have used a B19 nucleic acid test (NAT) to screen plasma pools and withhold from fractionation those with B19 DNA exceeding an established threshold. No study of populations using these products has been conducted to assess the impact of the screening on B19 transmission. Methods:Blood specimens obtained from participants of the CDC-sponsored Universal Data Collection (UDC) surveillance system of persons with bleeding disorders conducted by specialized US bleeding disorders clinics were used in a B19 seroprevalence study. Since B19 NAT screening began in 2000, only participants born after January 1, 2001 were eligible for study. Data collected on treatment products used by participants both prior to and after enrolment in UDC were used to categorize lifetime exposure as 1) no products, 2) recombinant (recomb) products only, 3) P-D products only, or 4) both recomb and P-D products. The proportions of participants with B19 IgG antibodies were compared across age and product exposure categories to determine whether users of products were at higher risk of past infection with B19 compared to those exposed to B19 only by the usual respiratory route. Results:A total of 1,643 specimens from 1,043 participants aged 2 – 7 years were tested. Demographic and clinical characteristics of study participants are shown in Table 1. Compared to subjects with no exposure to products, subjects in nearly every age group exposed to either P-D products alone or to both P-D and recomb products had a higher B19 prevalence (Table 2). In a logistic regression analysis that controlled for differences in the distribution of age, sex, bleeding disorder, treatment type, number of bleeds in previous 6 months, hemophilia inhibitor status, and year specimen obtained, participants exposed to P-D products alone were 1.7 times more likely to have B19 antibodies than those unexposed to blood or factor products (p = 0.002). In addition, there was a significant overall trend of increasing B19 prevalence over time.Table 1Characteristics of 1,043 children with bleeding disorders tested for exposure to Parvovirus B19.TotalCharacteristicN (%)Race/EthnicityWhite634 (60.8)Black125 (12.0)Hispanic194 (18.6)Other90 (8.6)SexMale870 (83.4)Female173 (16.6)Bleeding disorderHemophilia A537 (51.5)Hemophilia B141 (13.5)VWD322 (30.9)Other43 (4.1)Treatment typeEpisodic713 (68.4)Prophylaxis330 (31.6)Bleeds in past 6 mos.None462 (44.3)1 to 3363 (34.8)4+218 (20.9)Table 2Percent of specimens testing B19 positive by subject age and product exposure group.Age (years)NoneRecombinant onlyRecombinant and Plasma-derivedPlasma-derived only212.2 (90)19.0 (116)26.7* (15)32.3* (31)[7.0–20.6]323.5 (102)24.2 (124)15.4 (13)38.8* (49)[15.9–33.2]431.8 (126)35.6 (118)42.9* (21)48.7* (39)[23.9–40.7]538.8 (116)40.0 (125)50.0* (22)35.6 (45)[30.0–48.3]644.7 (94)50.4 (127)60.0* (15)56.2* (32)[34.5–55.3]750.0 (54)55.0 (129)50.0 (18)63.6 (22)[36.2–63.7]Number of samples tested in parentheses.Numbers in brackets are 95% confidence intervals (CI) for the proportion B19 seropositive.*p < 0.05 Discussion/Conclusion:P-D factor products are important therapies for people with VWD, hemophilia inhibitors and rarer factor deficiencies. Although we had no data on clinical illness, these serologic data provide evidence for continued transmission of B19 through these products after implementation of B19 NAT screening. Lowering the B19 threshold for plasma pool rejection should be considered. More importantly, effective viral inactivation processes are needed to protect users of these products not only from infection with B19 but from other as yet unidentified or emerging viruses that would not be detected by B19 NAT. Disclosures:Kessler:Novo Nordisk Inc.: Consultancy.

Iron Dextran Versus Iron Sucrose for Non-Hemodialysis Adult Outpatients with Iron Deficiency Anemia: Assessment of Safety and Feasibility for A Randomized Controlled Trial

Abstract▪2107▪This icon denotes a clinically relevant abstract Introduction:Iron deficiency is the most common cause of anemia worldwide affecting 50% of children under 5 years of age and 25% of women under the age of 50 (11% in the USA) worldwide. Standard treatment is oral iron supplementation, however this route of administration is associated with several adverse drug reactions (ADRs), the most common being epigastralgia and constipation leading to lack of compliance or dose reduction in 30% of patients. Intravenous (IV) iron is an alternative treatment for patients intolerant or non-responsive to oral formulations. Of the two most common formulations available in Canada, IV iron dextran is less expensive but may be associated with more overall ADRs compared to IV iron sucrose. Methods:We conducted a single centre, double-blinded pilot RCT to assess the feasibility of a full RCT to compare ADRs between iron dextran and iron sucrose in non-hemodialysis and IV iron treatment naïve adult patients with iron deficiency anemia. The incidence of immediate (during outpatient hospital visit) and delayed (within 24 hours after patient discharged) ADRs for each iron formulation were compared. Baseline characteristics of participants were analyzed by means of descriptive statistics. Demographic and clinical characteristics of study participants were evaluated by adverse reaction status. They were compared using a two-sample t-test for continuous variables and a two-way contingency table using Chi square or Fisher’s exact test for categorical variables, as appropriate. Patients were contacted 24 hours after discharge to answer a standardized questionnaire. Assessment of ADRs and severe ADRs were done using the standardized World Health Organization and International Conference on Harmonisation definitions. Grading of severity was done independently by three individuals from an independent Drug Safety Monitoring Board. Results:143 adult patients with iron deficiency anemia were were approached and erolled in the study between January 2008 and January 2009 (100% enrolment). Baseline characteristics of patients is depicted in Table 1. All patients received IV iron (73 iron dextran and 70 iron sucrose) and none were lost to follow-up. Immediate ADRs were similar between the two study arms; iron dextran 8/73 (11%) and iron sucrose 5/70 (7%), p=0.568. The average additional nursing time required to manage immediate ADRs was approximately 30 minutes. Delayed ADRs approached statistical significance with a higher rate of ADRs in the iron sucrose group [ iron dextran 9/73 (12%) and iron sucrose 18/70 (26%), p=0.0541]. Details in Table 2. Four patients were considered to have serious adverse reactions (shortness of breath, bronchospasm and diaphoresis). Two form each study arm. [Display omitted] [Display omitted] Conclusions:A RCT to compare adverse drug reaction rates between iron dextran and iron sucrose in non-hemodialysis adult patients with iron deficiency anemia is feasible. In our pilot study we were able to get 100% enrolment rate, in a timely fashion with no patients lost to follow up. The design of the study with a one point in time evaluation and a short follow up that did not require extra hospital visits and blood tests were probably attractive features that maximized patient participation. The incidence and severity of ADRs to both IV iron preparations studied were similar with greater than 25% of patients experiencing either immediate or delayed ADRs. However, a striking higher rate of delayed ADRs, albeit not severe, was slightly more pronounced in patients receiving iron sucrose therapy. The elevated level of ADRs to IV iron suggests the need for alternative formulations and a full RCT to compare the rate of ADRs between iron preparations is warranted. The choice of IV iron formulation in the adult non-hemodialysis population should take into account factors other than cost of the medication such as incidence and severity of ADRs, extra time required by Healthcare professionals, and patient preferences. Disclosures:No relevant conflicts of interest to declare.

Lymphocyte calcium influx characteristics and its modulation by Kv1.3 and IKCa1 potassium channel inhibitors in multiple sclerosis

Lymphocyte calcium influx characteristics and its modulation by Kv1.3 and IKCa1 potassium channel inhibitors in multiple sclerosis

Correlates of Self-Reported Nocturia Among Community-Dwelling Older Adults

Nocturia is a common and bothersome problem with multifactorial etiology. This study examines clinical factors that are associated with nocturia among community-dwelling older adults. A questionnaire-based survey was conducted among a convenience sample of community-dwelling older adults. Nocturia was defined as waking up to urinate two or more times per night for 3 or more days per week. Associations between nocturia status and sleep disturbance, daytime sleepiness, disease burden, and history of falls were determined. Questionnaires were mailed out to 433 participants, and returned questionnaires from 247 individuals (58%) individuals were adequate for analysis. There were 144 women (57%) and 103 men (42%), with mean +/- standard deviation age of 75.1 +/- 6.9 and 76.6 +/- 5.6 years for women and men, respectively. A total of 137 participants (55%) endorsed nocturia, and 57 participants (23%) endorsed nocturia and difficulty going back to sleep. Participants who endorsed nocturia and difficulty going back to sleep were more likely to report poor sleep quality, daytime sleepiness, increased disease burden, one or more falls, and symptoms related to primary sleep disorders. The clinical characteristics of study participants with nocturia and difficulty going back to sleep were different from those with nocturia and no difficulty going back to sleep, suggesting that these two conditions may have different etiological factors and clinical consequences. These findings would have important implications in both clinical and research-related activities aimed at the management of nocturia in older adults.