Maryland Medical Research Institute

Baltimore, MD, United States

Maryland Medical Research Institute

Baltimore, MD, United States
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Kiel D.P.,Institute for Aging Research | Hannan M.T.,Institute for Aging Research | Barton B.A.,Maryland Medical Research Institute | Bouxsein M.L.,Beth Israel Deaconess Medical Center | And 5 more authors.
Clinical Trials | Year: 2010

Background Osteoporosis is a common complication of aging. Alternatives to pharmacologic treatment are needed for older adults. Nonpharmacologic treatment with low magnitude, high frequency mechanical stimulation has been shown to prevent bone loss in animal and human studies. Methods The VIBES (Vibration to Improve Bone Density in Elderly Subjects) study is a randomized, double-blind, sham-controlled trial of the efficacy of low magnitude, high frequency mechanical stimulation in 200 men and women aged 60 years and older with bone mineral density T-scores by dual X-ray absorptiometry between -1 and -2.5 at entry. Participants are healthy, cognitively intact residents of independent living communities in the Boston area who receive free calcium and Vitamin D supplements. They are randomly assigned to active or sham treatment and stand on their assigned platform once daily for 10 min. All platforms have adherence data collection software downloadable to a laptop computer. Adverse events are closely monitored. 174 participants were randomized and will be followed for 2 years. Almost all active subjects have attained 1 year of follow-up. Bone mineral density is measured by both dual X-ray absorptiometry and quantitative computed tomography at baseline and annually. The main analysis will compare mean changes from baseline in volumetric bone density by quantitative computed tomography in active and sham groups. Adherence and treatment effect magnitude will also be evaluated. Secondary analyses will compare changes in two biochemical markers of bone turnover as well as longitudinal comparisons of muscle and balance endpoints. Results The VIBES trial has completed its first year of data collection and encountered multiple challenges leading to valuable lessons learned about the areas of recruitment from independent living communities, deployment of multiuser mechanical devices using radio frequency identification cards and electronic adherence monitoring, organization of transportation for imaging at a central site, and the expansion of study aims to include additional musculoskeletal outcomes. Conclusions These lessons will guide future investigations in studies of individuals of advanced age. © The Author(s), 2010.


Schwarz K.B.,Johns Hopkins University | Gonzalezperalta R.P.,University of Florida | Murray K.F.,Seattle Childrens Hospital | Molleston J.P.,Indiana University | And 13 more authors.
Gastroenterology | Year: 2011

Background & Aims Although randomized trials of adults infected with hepatitis C virus (HCV) have shown that ribavirin increases the efficacy of pegylated interferon (PEG), such trials have not been performed in children. We conducted a randomized controlled trial of PEG and ribavirin, compared with PEG and placebo, in children 5 to 17 years old with chronic hepatitis C. Methods HCV RNApositive children from 11 university medical centers were randomly assigned to receive either PEG alfa-2a (PEG-2a; 180 μg/1.73 m2 body surface area, subcutaneously each week; n = 55) and ribavirin (15 mg/kg orally in 2 doses daily) or PEG-2a and placebo (n = 59) for 48 weeks. The primary end point was sustained virologic response (SVR; lack of detectable HCV RNA at least 24 weeks after stopping therapy). Results SVR was achieved in 53% of children treated with PEG-2a and ribavirin, compared with 21% of children who received PEG-2a and placebo (P < .001). Early virologic response (HCV RNA reduction >2 log10 IU at 12 weeks) had a negative predictive value of only 0.89 in children with genotype 1, indicating that these children might benefit from 24 weeks of therapy before stopping treatment. Side effects, especially neutropenia, led to dose modification in 40% of children. Eighty-two percent of the PEG/ribavirin and 86% of the PEG/placebo group were in compliance with the year 2 follow-up visit; the durability of virologic response was 100% in both groups. Conclusions The combination of PEG and ribavirin is superior to PEG and placebo as therapy for chronic hepatitis C in children and adolescents. © 2011 AGA Institute.


Smith W.R.,Virginia Commonwealth University | Ballas S.K.,Thomas Jefferson University | Mccarthy W.F.,Maryland Medical Research Institute | Bauserman R.L.,Maryland Medical Research Institute | And 3 more authors.
Pain Medicine | Year: 2011

Background. We compared daily pain, home analgesic use, and utilization among ambulatory adults in the randomized Multicenter Study of Hydroxyurea in Sickle Cell Anemia (MSH). We related the fetal hemoglobin (HbF) hydroxyurea response to these response variables. Methods. Patients rated their sickle cell pain intensity (0-9), use of analgesics, and visits for pain daily. Diaries were collected biweekly, and intensity was collapsed into single interval ratings. The interval proportions of days of analgesic use and medical visits for pain were also calculated. Group comparisons were made by intention to treat as well as by HbF change levels from baseline to 2 years of treatment (placebo and low, medium, high, or very high response). Results. A total of 134 (44.8%) enrollees completed 2 years of follow-up. Pain intensity correlated with analgesic use (r=0.83, P>0.0001) and utilization (r=0.50, P<0.0001). Pain intensity was lower for patients on hydroxyurea (2.51±0.062 vs 2.82±0.063 placebo, F(1,270)=11.65, P=0.0007). The difference, though small, appeared early and was sustained. Analgesic use and utilization were also slightly lower (analgesic use: F(1,270)=11.97, P=0.0006; utilization: F(1,270)=32.0, P<0.0001). Each was statistically significantly lower among hydroxyurea patients with higher HbF treatment responses to hydroxyurea. Conclusions. Hydroxyurea usage led to a small, statistically significant reduction in daily pain, analgesic use, and utilization in adults in MSH, corroborating previously shown larger reductions in crises and mortality. The degree of daily symptomatic reduction was related to the size of the HbF treatment response, further confirming HbF response as a useful laboratory correlate. © 2011 Wiley Periodicals, Inc.


Ballas S.K.,Thomas Jefferson University | Bauserman R.L.,Maryland Medical Research Institute | McCarthy W.F.,Maryland Medical Research Institute | Castro O.L.,Howard University | And 2 more authors.
Journal of Pain and Symptom Management | Year: 2010

Context: Exploratory findings from the randomized, double-blind, placebo-controlled, multicenter study of hydroxyurea (MSH) in sickle cell anemia (SS). Recurrent acute painful crises may be mild, moderate, or severe in nature and often require treatment at home, in acute care facilities as outpatients, and in the hospital with oral and/or parenteral opioids. Objectives: The objectives of this study were to determine the effects of hydroxyurea (HU) on length of stay (LOS) in hospital and opioid utilization during hospitalization, outpatient acute care contacts, and at home. Methods: Data from patient diaries, follow-up visit forms, and medical contact forms for the 299 patients enrolled in the MSH were analyzed. Types and dosages of at home, acute care, and in-hospital analgesic usage were explored descriptively. Results: At-home analgesics were used on 40% of diary days and 80% of two-week follow-up periods, with oxycodone and codeine the most frequently used. Responders to HU used analgesics on fewer days. During hospitalization, 96% were treated with parenteral opioids, with meperidine the most frequently used; oxycodone was the most commonly used oral medication. The average LOS for responders to HU was about two days less than for other groups, and their cumulative time hospitalized during the trial was significantly less than for nonresponders or placebo groups (P < 0.022). They also had the lowest doses of parenteral opioids during acute care crises (P = 0.015). Conclusion: Beneficial effects of HU include shortening the duration of hospitalization because of acute painful episodes and reducing the net amount of opioid utilization. © 2010 U.S. Cancer Pain Relief Committee. Published by Elsevier Inc. All rights reserved.


Ballas S.K.,Thomas Jefferson University | Bauserman R.L.,Maryland Medical Research Institute | McCarthy W.F.,Maryland Medical Research Institute | Castro O.L.,Howard University | And 2 more authors.
American Journal of Hematology | Year: 2010

Several factors affect the severity and duration of sickle cell pain and its response to treatment with analgesics [1,2]. Sex has been one of the factors reported to influence the pain experience and the response to therapy [3]. Several chronic pain disorders, such as fibromyalgia, occur more frequently in females than in males [4,5]. Moreover, women seem to be more sensitive to painful stimuli than men [6]. However, whether differences in analgesic use by sex occur in patients with sickle cell anemia (SS) is unknown. Age also has been related to pain experience in many studies [7-9]. Moreover, we and others recently found an effect of geographic location and climatic conditions on frequency and severity of sickle cell pain [10,11]. Studies at single sites and anecdotal reports showed that climatic conditions, especially temperature can precipitate or exacerbate pain in sickle cell disease [12-14]. However, to the best of our knowledge, there are no multicenter, randomized, and placebo-controlled studies that relate all of these factors to pain management in sickle cell disease (SCD). The Multicenter Study of Hydroxyurea (MSH) in SS [15] gave us an opportunity to report on these aspects of sickle cell pain.


Ballas S.K.,Thomas Jefferson University | Bauserman R.L.,Maryland Medical Research Institute | McCarthy W.F.,Maryland Medical Research Institute | Waclawiw M.A.,U.S. National Institutes of Health
Journal of the National Medical Association | Year: 2010

The purpose of this study was to determine the association between hydroxyurea treatment and changes in employment status, if any, among patients with sickle cell anemia enrolled in the Multicenter Study of Hydroxyurea in Sickle Cell Anemia (MSH). To that end, we compared the employment status among treatment responders, treatment nonresponders, and placebo groups of patients enrolled in MSH during the clinical trial and follow-up periods. Treatment with hydroxyurea did not significantly (p > .05) affect employment status, but there was a trend for more consistent employment in the hydroxyurea group. Given the fact that patients enrolled in MSH had moderate to severe disease with irreversible complications such as avascular necrosis, it would be attractive to hypothesize that future treatment of young patients with hydroxyurea could prevent or mitigate the incidence of complications of sickle cell anemia and, hence, improve the employment status of treated patients.


Steg P.G.,University Paris Diderot | Kerner A.,Rambam Medical Center | Mancini G.B.J.,Vancouver General Hospital | Reynolds H.R.,New York University | And 7 more authors.
Circulation | Year: 2010

Background-: Collateral flow to the infarct artery territory after acute myocardial infarction may be associated with improved clinical outcomes and may also impact the benefit of subsequent recanalization of an occluded infarct-related artery. Methods and Results-: To understand the association between baseline collateral flow to the infarct territory on clinical outcomes and its interaction with percutaneous coronary intervention of an occluded infarct artery, long-term outcomes in 2173 patients with total occlusion of the infarct artery 3 to 28 days after myocardial infarction from the randomized Occluded Artery Trial were analyzed according to angiographic collaterals documented at study entry. There were important differences in baseline clinical and angiographic characteristics as a function of collateral grade, with generally lower-risk characteristics associated with higher collateral grade. Higher collateral grade was associated with lower rates of death (P=0.009), class III and IV heart failure (P<0.0001) or either (P=0.0002) but had no association with the risk of reinfarction. However, by multivariate analysis, collateral flow was neither an independent predictor of death nor of the primary end point of the trial (composite of death, reinfarction, or class IV heart failure). There was no interaction between angiographic collateral grade and the results of randomized treatment assignment (percutaneous coronary intervention or medical therapy alone) on clinical outcomes. CONCLUSIONS-: In recent myocardial infarction, angiographic collaterals to the occluded infarct artery are correlates but not independent predictors of major clinical outcomes. Late recanalization of the infarct artery in addition to medical therapy shows no benefit compared with medical therapy alone, regardless of the presence or absence of collaterals. Therefore, revascularization decisions in patients with recent myocardial infarction should not be based on the presence or grade of angiographic collaterals. © 2010 American Heart Association, Inc.


Franko D.L.,Northeastern University | Albertson A.M.,General Mills Inc. | Thompson D.R.,Maryland Medical Research Institute | Barton B.A.,Maryland Medical Research Institute
Public Health Nutrition | Year: 2011

Objective To examine the association between cereal consumption and cardiovascular risk factors including waist, height, total cholesterol, LDL cholesterol and HDL cholesterol in a sample of adolescent girls. Design Longitudinal study. Setting The study was conducted from 1987 to 1997 and data were collected at three study sites (University of California at Berkeley, University of Cincinnati and Westat Inc., Rockville, MD, USA). Mixed models were used to estimate the association between the number of days of eating cereal and these four outcome variables. Subjects Girls (n 2371) who participated in the 10-year National Heart, Lung, and Blood Growth and Health Study (NGHS) and completed a 3 d food diary in years 1-5 and 7, 8 and 10. Results Adolescent girls who ate cereal more often had lower waist-to-height ratio (P < 0·005), lower total cholesterol (P < 0·05) and lower LDL cholesterol (P < 0·05), taking into account sociodemographic variables, physical activity levels and total energy intake. Conclusions Findings suggest that cereal consumption is associated with markers of cardiovascular risk and that childhood patterns of consumption may influence the development of risk factors later in adolescence. © The Authors 2010.


Van Horn L.V.,Northwestern University | Bausermann R.,Maryland Medical Research Institute | Affenito S.,Saint Joseph's College | Thompson D.,Thompson Research Consulting LLC | And 3 more authors.
Nutrition Research | Year: 2011

The National Heart, Lung, and Blood Institute Growth and Health Study was a 10-year longitudinal study of the development of obesity and cardiovascular disease risk factors (including dietary, psychosocial, environmental, and others) in 2379 African American and white girls who were 9 or 10 years old at study entry. Current studies have documented a high prevalence of vitamin D insufficiency among healthy children, adolescents, and young adults in the United States, especially among low-income, black, and Hispanic children (defined as serum 25-hydroxyvitamin D concentrations of <20 ng/mL). Although the main source of vitamin D is direct exposure of the skin to ultraviolet rays from sunlight, certain foods contribute vitamin D including fortified milk, meat, eggs, oils, and fortified cereals. Vulnerable subgroups that are especially at risk for inadequate intakes of vitamin D include teenage girls and women. Research providing the prevalent food sources of vitamin D, especially in the diets of both white and African American female adolescents is limited. The purpose of this study is to document food sources of vitamin D reported by this biracial young cohort and compare potential ethnic or other differences that could enhance tailored dietary interventions that are particularly relevant to this vulnerable population subgroup. © 2011 Elsevier Inc.


Zimmerman S.,University of North Carolina at Chapel Hill | Magaziner J.,University of Maryland, Baltimore | Birge S.J.,University of Washington | Barton B.A.,Maryland Medical Research Institute | And 2 more authors.
Journal of the American Medical Directors Association | Year: 2010

Objectives: Determine nursing home characteristics related to adherence to use of a hip protector (HP) to prevent fracture; also describe adherence and related resident characteristics. Design: A multicenter, randomized controlled trial of a HP in which adherence to wearing the HP was monitored by research staff 3 times a week for up to 21 months; data were collected by interviews and chart review. Setting: Thirty-five nursing homes in Boston, St. Louis, and Baltimore. Participants: A total of 797 eligible residents, 633 (79%) of whom passed the run-in period, 397 (63%) of whom remained in the study until the end of follow-up. Intervention: Residents wore a single HP on their right or left side. Measurements: In addition to regular monitoring of adherence, data were collected regarding facility characteristics, staffing, policies and procedures, perception of HPs and related experience, and research staff ratings of environmental and overall quality; and also resident demographic characteristics, and function, health, and psychosocial status. Results: Facility characteristics related to more adherence were not being chain-affiliated; less Medicaid case-mix; fewer residents wearing HPs; more paraprofessional staff training; more rotating workers; and having administrators who were less involved in meetings. Conclusion: Efforts to increase adherence to the use of HPs should focus on facilities with more Medicaid case-mix to reduce disparities in care, and those that have less of a culture of training. Staff may need support to increase adherence, and when adherence cannot be maintained, HP use should be targeted to those who remain adherent. © 2010 American Medical Directors Association.

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