25 results on '"Strom BL"'
Search Results
2. Weight gain in the first week of life and overweight in adulthood: a cohort study of European American subjects fed infant formula.
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Stettler N, Stallings VA, Troxel AB, Zhao J, Schinnar R, Nelson SE, Ziegler EE, and Strom BL
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- 2005
3. Hormone replacement therapy regimens and breast cancer risk(1).
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Weiss LK, Burkman RT, Cushing-Haugen KL, Voigt LF, Simon MS, Daling JR, Norman SA, Bernstein L, Ursin G, Marchbanks PA, Strom BL, Berlin JA, Weber AL, Doody DR, Wingo PA, McDonald JA, Malone KE, Folger SG, Spirtas R, and Weiss, Linda K
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- 2002
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4. Treatment of osteoporosis: are physicians missing an opportunity?
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Freedman KB, Kaplan FS, Bilker WB, Strom BL, Lowe RA, Freedman, K B, Kaplan, F S, Bilker, W B, Strom, B L, and Lowe, R A
- Abstract
Background: Medical treatment of women with established osteoporosis may decrease the incidence of future fractures. Postmenopausal women who have sustained a distal radial fracture have decreased bone-mineral density and nearly twice the risk of a future hip fracture. The purpose of this study was to evaluate the adequacy of diagnosis and treatment of osteoporosis in postmenopausal women following an acute fracture of the distal part of the radius.Methods: A retrospective cohort study was performed with use of a claims database that includes more than three million patients, from thirty states, enrolled in multiple health plans. All women, fifty-five years of age or older, who sustained a distal radial fracture between July 1, 1994, and June 30, 1997, were identified in the database. Only patients with at least six months of continuous and complete medical and pharmaceutical health-care coverage from the date of the fracture were enrolled, to ensure that all health-care claims would be captured in the database. This cohort of patients was then evaluated to determine the proportion who had undergone either a diagnostic bone-density scan or treatment with any recommended medication for established osteoporosis (estrogen, a bisphosphonate, or calcitonin) within six months following the fracture.Results: A search of the database identified 1,162 women, fifty-five years of age or older, who had a distal radial fracture. Of these 1,162 patients, thirty-three (2.8 percent) underwent a bone-density scan and 266 (22.9 percent) were treated with at least one of the medications approved for treatment of established osteoporosis. Twenty women had both a bone-density scan and drug treatment. Therefore, only 279 (24.0 percent) of the 1,162 women who sustained a distal radial fracture underwent either diagnostic evaluation or treatment of osteoporosis. There was a significant decrease in the rate of treatment of osteoporosis with increasing patient age at the time of the fracture (p < 0.0001).Conclusions: Current physician practice may be inadequate for the diagnosis and treatment of osteoporosis in postmenopausal women who have sustained a distal radial fracture. [ABSTRACT FROM AUTHOR]- Published
- 2000
5. Methodologic challenges to studying patient safety and comparative effectiveness.
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Strom BL
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- 2007
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6. Impact of the COVID-19 Pandemic on the Management of Juvenile Idiopathic Arthritis: Analysis of United States Commercial Insurance Data.
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Horton DB, Yang Y, Neikirk A, Huang C, Crystal S, Davidow A, Haynes K, Gerhard T, Rose CD, Strom BL, and Parlett L
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- Child, Humans, Pandemics, Quality of Life, Retrospective Studies, Glucocorticoids therapeutic use, COVID-19 epidemiology, Arthritis, Juvenile drug therapy, Arthritis, Juvenile epidemiology, Antirheumatic Agents therapeutic use, Insurance
- Abstract
Background/objective: Given limited information on health care and treatment utilization for juvenile idiopathic arthritis (JIA) during the pandemic, we studied JIA-related health care and treatment utilization in a commercially insured retrospective US cohort., Methods: We studied rates of outpatient visits, new disease-modifying antirheumatic drug (DMARD) initiations, intra-articular glucocorticoid injections (iaGC), dispensed oral glucocorticoids and opioids, DMARD adherence, and DMARD discontinuation by quarter in March 2018-February 2021 (Q1 started in March). Incident rate ratios (IRR, pandemic vs prepandemic) with 95% confidence intervals (CIs) were estimated using multivariable Poisson or Quasi-Poisson models stratified by diagnosis recency (incident JIA, <12 months ago; prevalent JIA, ≥12 months ago)., Results: Among 1294 children diagnosed with JIA, total and in-person outpatient visits for JIA declined during the pandemic (IRR, 0.88-0.90), most markedly in Q1 2020. Telemedicine visits, while higher during the pandemic, declined from 21% (Q1) to 13% (Q4) in 2020 to 2021. During the pandemic, children with prevalent JIA, but not incident JIA, had lower usage of iaGC (IRR, 0.60; 95% CI, 0.34-1.07), oral glucocorticoids (IRR, 0.47; 95% CI, 0.33-0.67), and opioids (IRR, 0.44; 95% CI, 0.26-0.75). Adherence to and discontinuation of DMARDs was similar before and during the pandemic., Conclusions: In the first year of the pandemic, visits for JIA dropped by 10% to 12% in commercially insured children in the United States, declines partly mitigated by use of telemedicine. Pandemic-related declines in intra-articular glucocorticoids, oral glucocorticoids, and opioids were observed for children with prevalent, but not incident, JIA. These changes may have important implications for disease control and quality of life., Competing Interests: Disclosures: D.B.H. has received salary support and grant funding related to JIA from the Childhood Arthritis and Rheumatology Research Alliance, and honorarium related to JIA from the American College of Rheumatology, and unrelated grant funding from Danisco USA, Inc. Y.Y., A.L.N., and L.E.P. are employees of Carelon Research, Inc. Kevin Haynes is an employee of Janssen Research & Development. C.D.R. provides consultation to AbbVie and Novartis about therapies for JIA and advises the Department of Health and Human Services on autoimmune vaccine injuries. B.L.S. has received consulting fees from AbbVie and the Consumer Healthcare Products Association. L.E.P. has received research support from Sanofi unrelated to this work. C.H., S.C., A.D., and T.G. report no potential conflicts of interest., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)
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- 2023
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7. CYP2B6 genotypes and early efavirenz-based HIV treatment outcomes in Botswana.
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Gross R, Bellamy SL, Ratshaa B, Han X, Vujkovic M, Aplenc R, Steenhoff AP, Mosepele M, Moorthy G, Zuppa AF, Strom BL, and Bisson GP
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- Adult, Aged, Alkynes, Anti-HIV Agents adverse effects, Benzoxazines adverse effects, Botswana, Cyclopropanes, Drug-Related Side Effects and Adverse Reactions epidemiology, Female, Genotyping Techniques, Humans, Male, Middle Aged, Prospective Studies, RNA, Viral blood, Surveys and Questionnaires, Survival Analysis, Treatment Outcome, Viral Load, Young Adult, Anti-HIV Agents therapeutic use, Benzoxazines therapeutic use, Cytochrome P-450 CYP2B6 genetics, Genotype, HIV Infections drug therapy
- Abstract
Objectives: To determine the association between cytochrome p450 2B6 genotypes and efavirenz-based HIV treatment outcomes., Design: Observational cohort study of HIV-infected adults initiating efavirenz-based regimens in Botswana., Methods: The primary endpoint was a composite of death or loss to care or HIV RNA more than 25 copies/ml at 6 months. CYP2B6 516G>T and 983T>C genotyping was done with Taqman Open Array platform. Adverse experiences were measured by using the Subject Experience Questionnaire. Metabolism alleles were included in logistic regression models of the composite endpoint., Results: A total of 801 individuals included 406 (51%) men, median age 37 years, median baseline CD4 cell count 195 cells/μl, and plasma HIV RNA 4.9 log10 copies/ml. 288 (36%) reached the endpoint, including 34 (4%) deaths, 151 (19%) lost to care, 11 (1%) lost to the study, but alive and in care, and 92 (11%) with plasma HIV RNA more than 25 copies/ml. Metabolism variant alleles were common with 396 (49%) intermediate and 192 (24%) slow metabolizers. There were no statistically significant associations between metabolism and treatment endpoints. However, slower metabolism was associated with fewer adverse experiences., Conclusion: Slow metabolism alleles were associated with lower efavirenz clearance but not any of the treatment endpoints. Slow efavirenz metabolism did not exacerbate central nervous system toxicity. These results should allay concern that slow efavirenz metabolism adversely impacts individuals in sub-Saharan African settings in which these alleles are common.
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- 2017
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8. Access to Developmental Pediatrics Evaluations for At-Risk Children.
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Jimenez ME, Martinez Alcaraz E, Williams J, and Strom BL
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- Health Services Accessibility standards, Hospitals, Pediatric standards, Humans, Pediatricians standards, Risk, United States, Developmental Disabilities diagnosis, Health Services Accessibility statistics & numerical data, Hospitals, Pediatric statistics & numerical data, Pediatricians statistics & numerical data
- Abstract
Objective: To determine a national average wait time for developmental pediatric evaluations and to understand differences in access based on whether an appointment is requested by an English or Spanish-speaking caller., Methods: We conducted a mystery shopper study in which a bilingual research assistant called developmental pediatrics programs affiliated with US children's hospitals listed on a public directory requesting an appointment for his simulated child experiencing a developmental problem. If an appointment was not provided, a wait time estimate was requested. Programs that provided an estimate in English were called within 24 hours using a translated script. We excluded programs that did not include a developmental pediatrician, only accepted referrals from within their health system or plan, focused on specific disorders, or did not conduct initial evaluations., Results: Of 244 hospitals listed, 140 unique programs were identified and called in English. One hundred four programs were reached. Ninety programs met inclusion criteria, 75 provided an estimated wait time. The mean estimate was 5.4 months (standard deviation: 4.5). Among these 75 programs, 62 were reached in Spanish but only 55% provided a wait time estimate; 31% did not provide language accommodations. The difference between average estimates obtained in English and Spanish was not statistically significant., Conclusion: Among a national sample of US children's hospitals, we identified barriers to evaluations conducted by developmental pediatricians including long wait times and inadequate Spanish language accommodations at some programs. More work is needed to identify optimal strategies to connect children with developmental concerns to evaluations when necessary.
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- 2017
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9. Validation of 6-minute walk distance as a surrogate end point in pulmonary arterial hypertension trials.
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Gabler NB, French B, Strom BL, Palevsky HI, Taichman DB, Kawut SM, and Halpern SD
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- Adult, Disability Evaluation, Drug Monitoring methods, Endothelin Receptor Antagonists, Familial Primary Pulmonary Hypertension, Female, Humans, Male, Middle Aged, Randomized Controlled Trials as Topic methods, Randomized Controlled Trials as Topic standards, Recovery of Function drug effects, Recovery of Function physiology, Reproducibility of Results, Treatment Outcome, Drug Monitoring standards, Hypertension, Pulmonary drug therapy, Hypertension, Pulmonary physiopathology, Phosphodiesterase Inhibitors therapeutic use, Prostaglandins therapeutic use, Walking
- Abstract
Background: Nearly all available treatments for pulmonary arterial hypertension have been approved based on change in 6-minute walk distance (Δ6MWD) as a clinically important end point, but its validity as a surrogate end point has never been shown. We aimed to validate the difference in Δ6MWD against the probability of a clinical event in pulmonary arterial hypertension trials., Methods and Results: First, to determine whether Δ6MWD between baseline and 12 weeks mediated the relationship between treatment assignment and development of clinical events, we conducted a pooled analysis of patient-level data from the 10 randomized placebo-controlled trials previously submitted to the US Food and Drug Administration (n=2404 patients). Second, to identify a threshold effect for the Δ6MWD that indicated a statistically significant reduction in clinical events, we conducted a meta-regression among 21 drug/dose-level combinations. Δ6MWD accounted for 22.1% (95% confidence interval, 12.1%- 31.1%) of the treatment effect (P<0.001). The meta-analysis showed an average difference in Δ6MWD of 22.4 m (95% confidence interval, 17.4-27.5 m), favoring active treatment over placebo. Active treatment decreased the probability of a clinical event (summary odds ratio, 0.44; 95% confidence interval, 0.33-0.57). The meta-regression revealed a significant threshold effect of 41.8 m., Conclusions: Our results suggest that Δ6MWD does not explain a large proportion of the treatment effect, has only modest validity as a surrogate end point for clinical events, and may not be a sufficient surrogate end point. Further research is necessary to determine whether the threshold value of 41.8 m is valid for long-term outcomes or whether it differs among trials using background therapy or lacking placebo controls entirely.
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- 2012
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10. A comparison of change in the 0-10 numeric rating scale to a pain relief scale and global medication performance scale in a short-term clinical trial of breakthrough pain intensity.
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Farrar JT, Polomano RC, Berlin JA, and Strom BL
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- Administration, Oral, Adolescent, Adult, Aged, Cohort Studies, Cross-Over Studies, Double-Blind Method, Female, Humans, Male, Middle Aged, Pain Measurement methods, Time Factors, Young Adult, Fentanyl administration & dosage, Morphine administration & dosage, Pain diagnosis, Pain drug therapy, Pain Measurement standards
- Abstract
Background: Pain intensity is commonly reported using a 0-10 Numeric Rating Scale in pain clinical trials. Analysis of the change on the Pain Intensity Numerical Rating Scale as a proportion has most consistently correlated with clinically important differences reported on the patient's global impression of change. The correlation of data from patients with breakthrough pain with a Pain Relief Scale and a different global outcome measures will extend our understanding of these measures., Methods: Data were obtained from the open titration phase of a multiple crossover, randomized, double-blind clinical trial comparing oral transmucosal fentanyl citrate with immediate-release oral morphine sulfate for the treatment of cancer-related breakthrough pain. Raw and percentage changes in the pain intensity scores from 1,307 episodes of pain in 134 oral transmucosal fentanyl citrate-naïve patients were correlated with the clinically relevant secondary outcomes of Pain Relief Verbal Response Scale and the global medication performance scale. The changes in raw and percentage change were assessed over time and compared with the ordinal Pain Relief Verbal Response Scale and Global Medication Performance Scale., Results: The P value of the interaction between the raw pain intensity difference was significant (P = 0.034) for four 15-min time periods but not for the percentage pain intensity difference score (P = 0.26). We found similar results in comparison with the ordinal Pain Relief Verbal Response Scale (P = 0.0048 and P = 0.36 respectively) and global medication performance categories (P = 0.048 and P = 0.45, respectively)., Conclusion: The change in pain intensity in breakthrough pain was more consistent over time and when compared with both the Pain Relief Verbal Response Scale and the Global Medication Performance Scale when the percentage change is used rather than raw pain intensity difference.
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- 2010
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11. Statin use and the risk of 10 cancers.
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Coogan PF, Rosenberg L, and Strom BL
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- Adult, Aged, Case-Control Studies, Female, Humans, Incidence, Male, Middle Aged, Neoplasms prevention & control, Odds Ratio, Risk, Hydroxymethylglutaryl-CoA Reductase Inhibitors therapeutic use, Neoplasms epidemiology
- Abstract
Background: Statins affect the proliferation, survival, and migration of cancer cells, and it is thought that they may have chemopreventive properties in humans. The purpose of the present study was to evaluate the association between statin use and various types of cancer in our hospital-based case-control surveillance study., Methods: Data were collected from patients ages 40-79 years who were admitted to participating hospitals in 3 centers in Philadelphia, New York, and Baltimore from 1991 to 2005. Nurses administered questionnaires to obtain information on medication use and other factors. We compared patients who had any of 10 types of cancer (a total of 4913 patients) with controls admitted for noncancer diagnoses (3900 patients). The following cancers were examined individually: female breast (n = 1185), prostate (n = 1226), colorectal (n = 734), lung (n = 464), bladder (n = 240), leukemia (n = 254), pancreas (n = 220), kidney (n = 226), endometrial (n = 220), and non-Hodgkin lymphoma (n = 144). Logistic regression models were used to estimate odds ratios and 95% confidence intervals among regular statin users compared with never-users., Results: Odds ratios were compatible with 1.0 for all cancer types. For the 4 largest cancer sites (breast, prostate, colorectum, and lung), odds ratios did not vary significantly by duration of statin use., Conclusions: Statins are among the most commonly used medications, and durations of use are increasing. The present data do not support either positive or negative associations between statin use and the occurrence of 10 cancer types. Cancer incidence should continue to be monitored among statin users.
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- 2007
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12. Diagnostic accuracy of CD4 cell count increase for virologic response after initiating highly active antiretroviral therapy.
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Bisson GP, Gross R, Strom JB, Rollins C, Bellamy S, Weinstein R, Friedman H, Dickinson D, Frank I, Strom BL, Gaolathe T, and Ndwapi N
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- Adolescent, Adult, Aged, Female, HIV Infections blood, HIV Infections immunology, Humans, Male, Middle Aged, RNA, Viral blood, ROC Curve, Reproducibility of Results, Retrospective Studies, Time Factors, Viral Load methods, Antiretroviral Therapy, Highly Active methods, CD4 Lymphocyte Count methods, HIV Infections drug therapy, HIV-1 immunology
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Objective: To derive and internally validate a clinical prediction rule for virologic response based on CD4 cell count increase after initiation of HAART in a resource-limited setting., Design and Methods: A retrospective cohort study at two HIV care clinics in Gaborone, Botswana. The participants were previously treatment-naive HIV-1-infected individuals initiating HAART. The main outcome measure was a plasma HIV-1 RNA level (viral load) < or = 400 copies/ml (i.e. undetectable) 6 months after initiating HAART., Results: The ability of CD4 cell count increase to predict an undetectable viral load was significantly better in those with baseline CD4 cell counts < or = 100 cells/microl [area under the ROC curve (AUC), 0.78; 95% confidence interval (CI), 0.67-0.89; versus AUC, 0.60; 95% CI, 0.48-0.71; P = 0.018]. The sensitivity, specificity, and positive and negative predictive values of a CD4 cell count increase of > or = 50 cells/microl for an undetectable viral load in those with baseline CD4 cell counts < or = 100 cells/microl were 93.1, 61.3, 92.5 and 63.3%, respectively. Alternatively, these values were 47.8, 87.1, 95.0 and 24.5%, respectively, if a increase in CD4 cell count of > or = 150 cells/microl was used., Conclusions: CD4 cell count increase after initiating HAART has only moderate discriminative ability in identifying patients with an undetectable viral load, and the predictive ability is higher [corrected] in patients with lower baseline CD4 cell counts. Although HIV treatment programs in resource-constrained settings could consider the use of CD4 cell count increases to triage viral load testing, more accurate approaches to monitoring virologic failure are urgently needed.
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- 2006
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13. Out-of-pocket costs of HAART limit HIV treatment responses in Botswana's private sector.
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Bisson GP, Frank I, Gross R, Lo Re V 3rd, Strom JB, Wang X, Mogorosi M, Gaolathe T, Ndwapi N, Friedman H, Strom BL, and Dickinson D
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- Adult, Aged, Anti-Retroviral Agents therapeutic use, Antiretroviral Therapy, Highly Active, Botswana, Drug Costs, Female, Humans, Male, Middle Aged, Private Sector, Time Factors, Anti-Retroviral Agents economics, HIV Infections drug therapy, HIV-1
- Abstract
A large number of HIV-infected patients in sub-Saharan Africa pay out-of-pocket for HAART. This analysis from Botswana indicates that higher median out-of-pocket regimen costs to patients for the initial 30 days of HAART are associated with failure to achieve a viral load< 400 copies/ml [US$32; interquartile range (IQR), 20-84 compared with US$22; (IQR, 17-36), P = 0.001]. HAART costs should be minimized as scale-up efforts in sub-Saharan Africa progress.
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- 2006
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14. Effect of GB virus C viremia on HIV acquisition and HIV set-point.
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Bisson GP, Strom BL, Gross R, Weissman D, Klinzman D, Hwang WT, Kostman JR, Metzger D, Stapleton JT, and Frank I
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- Adult, Case-Control Studies, Cohort Studies, Disease Progression, Female, Flaviviridae Infections complications, HIV genetics, HIV Infections blood, HIV Infections complications, Hepatitis, Viral, Human complications, Humans, Male, RNA, Viral blood, Viremia complications, Flaviviridae Infections virology, GB virus C, HIV Infections virology, Hepatitis, Viral, Human virology, Viremia virology
- Abstract
We performed both a case-control study and a cohort study to determine whether GB virus C (GBV-C) viremia prevents the acquisition of HIV infection or alters the HIV set-point after infection. The prevalence of GBV-C viremia in HIV-uninfected individuals who did and did not acquire HIV were similar (odds ratio 1.32; 95% confidence interval 0.6-2.6). Pre-existing GBV-C viremia at the time of HIV acquisition was also not associated with lower plasma HIV-RNA levels.
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- 2005
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15. Association of catechol-O-methyltransferase with smoking cessation in two independent studies of women.
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Colilla S, Lerman C, Shields PG, Jepson C, Rukstalis M, Berlin J, DeMichele A, Bunin G, Strom BL, and Rebbeck TR
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- Aged, Case-Control Studies, Female, Humans, Middle Aged, Nicotine administration & dosage, Catechol O-Methyltransferase metabolism, Smoking Cessation
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Objectives and Methods: The Val108/158Met polymorphism in the gene that encodes COMT, a dopamine metabolizing enzyme, results in a three- to four-fold reduction in COMT activity. To determine if the lower activity Met allele of COMT was associated with smoking cessation in women, we used two independent studies: a population-based case--control study and a nicotine replacement clinical trial., Results: In the case--control study, women with two Met alleles were significantly more likely to be ex-smokers than current smokers [OR=1.82, 95% CI (1.05, 3.17), P=0.03]. In the nicotine replacement clinical trial, among women, the Met/Met genotype was associated with a higher probability of smoking cessation based on both point prevalence and prolonged abstinence outcomes [OR=2.96, 95% CI (1.07, 8.14), P=0.04; OR=3.23, 95% CI (1.13, 9.20), P=0.03, respectively]., Conclusions: This first report of a significant association between COMT Val108/158Met and smoking cessation suggests that COMT variation has an effect on smoking behavior in women.
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- 2005
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16. Adverse events after protamine administration following cardiopulmonary bypass in infants and children.
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Seifert HA, Jobes DR, Ten Have T, Kimmel SE, Montenegro LM, Steven JM, Nicolson SC, and Strom BL
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- Adolescent, Case-Control Studies, Child, Child, Preschool, Female, Humans, Hypotension chemically induced, Infant, Infant, Newborn, Male, Multivariate Analysis, Odds Ratio, Retrospective Studies, Risk Factors, Cardiopulmonary Bypass, Heparin Antagonists adverse effects, Protamines adverse effects
- Abstract
Unlabelled: We performed this study to determine the incidence of and risk factors for adverse events (AEs) in infants and children after the IV administration of protamine after cardiopulmonary bypass. In a retrospective cohort study, all relevant anesthesia records from a 3-yr period were examined to identify AEs after protamine. The AEs were then grouped into three categories by applying increasingly strict criteria. Among 1249 anesthesia records, there were no documented episodes of isolated or hypotension-associated right-sided cardiac failure or acute pulmonary dysfunction. The incidence of systemic hypotension after protamine was between 1.76% (95% confidence interval [CI], 1.11%-2.65%) and 2.88% (95% CI, 2.03%-3.97%), depending on the strictness of case definition. To identify risk factors, we performed a nested case-control study in which unmatched controls were randomly selected from the parent cohort at a 4:1 ratio to cases. Cases of hypotension after protamine were more likely during operations on girls (odds ratio [OR], 6.47; 95% CI, 1.66-32.8), after larger doses of protamine (OR, 1.88; 95% CI, 1.03-3.63), or after smaller doses of heparin (OR, 0.49; 95% CI, 0.17-0.67)., Implications: Systemic hypotension after protamine administration occurred in 1.76%-2.88% of pediatric patients having cardiac surgery. Female sex, larger protamine dose, and smaller heparin dose were each associated with increased risk. The development of protamine alternatives or prophylactic therapies may be useful for reducing the frequency of these events.
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- 2003
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17. Provider inaccuracy in assessing adherence and outcomes with newly initiated antiretroviral therapy.
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Gross R, Bilker WB, Friedman HM, Coyne JC, and Strom BL
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- Adult, Female, Humans, Male, Middle Aged, Outcome and Process Assessment, Health Care, Predictive Value of Tests, Prospective Studies, Treatment Outcome, Antiretroviral Therapy, Highly Active, Attitude of Health Personnel, HIV Infections drug therapy, Nurse Practitioners, Patient Compliance, Physicians
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We studied the ability of providers to predict and estimate patient adherence to newly initiated highly active antiretroviral therapy (HAART). Nineteen providers referring 40 patients into an adherence study were surveyed. Widespread inaccuracy was found in providers' adherence predictions and estimates. Therefore, HAART should not be withheld solely on provider predictions of adherence. Providers should not rely on their own assessments when attempting to determine if patients are adhering to therapy.
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- 2002
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18. Statin use and the risk of breast and prostate cancer.
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Coogan PF, Rosenberg L, Palmer JR, Strom BL, Zauber AG, and Shapiro S
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- Aged, Female, Humans, Male, Middle Aged, Odds Ratio, United States epidemiology, Breast Neoplasms epidemiology, Hydroxymethylglutaryl-CoA Reductase Inhibitors therapeutic use, Prostatic Neoplasms epidemiology
- Abstract
Background: Laboratory data suggest that the cholesterol-lowering "statin" drugs may have chemopreventive potential against cancer at various sites, including breast and prostate. However, in one trial of pravastatin there was a significant excess of breast cancer in the treatment group. In the present study, we assessed the relation of statin use to the risk of breast and prostate cancer in our hospital-based Case-Control Surveillance Study of Drugs and Serious Illnesses., Methods: Cases were 1,132 women with breast cancer and 1,009 men with prostate cancer; controls were 1,331 women and 1,387 men admitted for conditions unrelated to statin use. We used multivariate unconditional logistic regression models to estimate odds ratios (ORs) and 95% confidence intervals (CIs) for use of statins compared with no use., Results: The OR for breast cancer among statin users was 1.5 (95% CI = 1.0-2.3), largely accounted for by an OR of 1.8 (95% CI = 0.9-3.6) among cases with carcinoma in situ. Among invasive cases, the OR was 1.2 (95% CI = 0.7-2.0). The odds ratio for prostate cancer overall was 1.2 (95% CI = 0.8-1.7), and it was 1.4 (95% CI = 0.7-2.5) for Stage A., Conclusions: The data from the present study do not support a protective effect of statins against breast or prostate cancer. Detection bias is a possible explanation for the higher ORs observed for carcinoma in situ or early-stage cancer as compared with more invasive cancer.
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- 2002
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19. Response to first drug trial predicts outcome in childhood temporal lobe epilepsy.
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Dlugos DJ, Sammel MD, Strom BL, and Farrar JT
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- Child, Child, Preschool, Female, Humans, Male, Models, Neurological, Predictive Value of Tests, Prognosis, Anticonvulsants therapeutic use, Epilepsy, Temporal Lobe drug therapy, Epilepsy, Temporal Lobe physiopathology
- Abstract
Objective: To construct a clinical prediction model for the early identification of children destined to develop refractory temporal lobe epilepsy (TLE) 2 years after epilepsy onset., Methods: Patients with TLE between 1 and 18 years old seen in the Division of Neurology at Children's Hospital of Philadelphia during 1999 were identified through billing records and chart review. Data were abstracted independently on 5 candidate predictor variables for refractory TLE and on seizure frequency outcome at 2 years after epilepsy onset., Results: One hundred twenty patients met inclusion criteria and had at least 2 years of follow-up. Forty-five of 120 patients (37.5%) had refractory TLE at 2 years after onset, and 75 of 120 (62.5%) were seizure free. Three significant predictors of refractory TLE were found on bivariate analysis: an early risk factor for epilepsy (risk ratio = 3.5 [95% CI 2.2, 5.6]), temporal lobe abnormality on MRI scan (2.9 [95% CI 1.9, 4.6]), and failure of the first antiepileptic drug (AED) trial (16.5 [95% CI 6.3, 43.9]). Logistic regression indicated that the best model to predict refractory TLE contained only the variable "failure of first AED trial," with a positive predictive value of 0.89 (95% CI 0.76, 0.96) and negative predictive value of 0.95 (95% CI 0.87, 0.99) to predict "refractory TLE" at 2 years., Conclusions: Failure of first AED trial accurately predicts refractory TLE at 2 years after onset, based on retrospective cohort data in children. If verified prospectively and with longer follow-up, this finding should support earlier consideration of surgical options.
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- 2001
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20. Effect of adherence to newly initiated antiretroviral therapy on plasma viral load.
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Gross R, Bilker WB, Friedman HM, and Strom BL
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- Adult, Aged, CD4 Lymphocyte Count, Cohort Studies, Drug Therapy, Combination, Female, HIV Infections immunology, HIV Infections virology, HIV-1 physiology, Humans, Male, Middle Aged, RNA, Viral blood, Anti-HIV Agents therapeutic use, HIV Infections drug therapy, Patient Compliance, Reverse Transcriptase Inhibitors therapeutic use, Viral Load
- Abstract
Objective: To determine whether differences in adherence to newly initiated antiretroviral therapy exist between subjects who do and do not achieve undetectable plasma viral loads., Design: Observational cohort study monitoring adherence and virological and immunological parameters over the initial 4 months of therapy with nelfinavir. Adherence was measured using the microelectronic monitoring system (MEMS; APREX Corporation, Menlo Park, California, USA)., Setting: General Clinical Research Center at a tertiary care center., Participants: Forty-one protease inhibitor-naive subjects with viral loads > 10 000 copies/ml newly starting a regimen including nelfinavir, referred from HIV clinics in Philadelphia., Main Outcome Measures: The primary outcome was undetectable viral load (< 50 copies/ml) after 4 months. Secondary measures included changes in viral load and CD4 cell counts. We hypothesized that adherence would be greater in subjects who achieved undetectable viral loads., Results: Adherence was greater in undetectable subjects, who took a median of 93% of prescribed doses [interquartile range (IQR) 84-96%], whereas detectable subjects took a median of 70% (IQR 46-93%). Adherence correlated with viral load decrease (Spearman's rho = 0.38, P < 0.01) and CD4 cell count increase (Spearman's rho = 0.25, P = 0.06). Despite differences between the groups over 4 months of therapy, there were no adherence differences over the first month [undetectables, 95% (IQR 88-98%) versus detectables, 94% (IQR 87-98%), P > 0.50]., Conclusions: Adherence is important in determining whether or not individuals achieve suppression with a newly initiated antiretroviral regimen. Adherence begins to wane after the first month of therapy. Therefore, closer assessment of adherence particularly after this first month is important.
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- 2001
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21. Risk factors for infective endocarditis: oral hygiene and nondental exposures.
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Strom BL, Abrutyn E, Berlin JA, Kinman JL, Feldman RS, Stolley PD, Levison ME, Korzeniowski OM, and Kaye D
- Subjects
- Adolescent, Adult, Aged, Anti-Bacterial Agents adverse effects, Anti-Bacterial Agents therapeutic use, Barium Sulfate, Comorbidity, Delaware epidemiology, Diabetes Complications, Diabetes Mellitus epidemiology, Endocarditis, Bacterial etiology, Enema adverse effects, Female, Fluid Therapy adverse effects, Heart Valve Diseases complications, Heart Valve Diseases epidemiology, Heart Valve Diseases surgery, Heart Valve Prosthesis adverse effects, Heart Valve Prosthesis microbiology, Humans, Kidney Failure, Chronic complications, Kidney Failure, Chronic epidemiology, Logistic Models, Male, Middle Aged, Oral Hygiene standards, Oxygen Inhalation Therapy adverse effects, Pennsylvania epidemiology, Risk Factors, Skin microbiology, Skin Diseases complications, Skin Diseases epidemiology, Skin Diseases microbiology, Endocarditis, Bacterial epidemiology, Environmental Exposure, Oral Hygiene methods
- Abstract
Background: The risks of infective endocarditis (IE) associated with various conditions and procedures are poorly defined., Methods and Results: This was a population-based case-control study conducted in 54 Philadelphia, Pa-area hospitals from 1988 to 1990. Community-acquired IE cases unassociated with intravenous drug use were compared with matched community residents. Subjects were interviewed for risk factors. Diagnoses were confirmed by expert review of medical record abstracts with risk factor data removed. Cases were more likely than controls to suffer from prior severe kidney disease (adjusted OR [95% CI]=16.9 [1.5 to 193], P:=0.02) and diabetes mellitus (adjusted OR [95% CI]=2.7 [1.4 to 5.2], P:=0.004). Cases infected with skin flora had received intravenous fluids more often (adjusted OR [95% CI]=6.7 [1.1 to 41], P:=0.04) and had more often had a previous skin infection (adjusted OR [95% CI]=3.5 [0.7 to 17], P:=0.11). No association was seen with pulmonary, gastrointestinal, cardiac, or genitourinary procedures or with surgery. Edentulous patients had a lower risk of IE from dental flora than patients who had teeth but did not floss. Daily flossing was associated with a borderline decreased IE risk., Conclusions: Within the limits of the available sample size, the data showed that IE patients differ from people without IE with regard to certain important risk factors but not regarding recent procedures.
- Published
- 2000
- Full Text
- View/download PDF
22. Defining the clinically important difference in pain outcome measures.
- Author
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Farrar JT, Portenoy RK, Berlin JA, Kinman JL, and Strom BL
- Subjects
- Analgesics, Opioid therapeutic use, Clinical Trials, Phase I as Topic, Clinical Trials, Phase II as Topic, Confidence Intervals, Cross-Over Studies, Double-Blind Method, Fentanyl therapeutic use, Humans, Logistic Models, Pain Measurement psychology, Pain, Intractable drug therapy, Randomized Controlled Trials as Topic, Pain Measurement methods, Treatment Outcome
- Abstract
The purpose of this study was to determine the levels of change on standard pain scales that represent clinically important differences to patients. Data from analgesic studies are often difficult to interpret because the clinical importance of the results is not obvious. Differences between groups, as summarized by a change in mean values over time, can be difficult to apply to clinical care. Baseline scores vary widely and group mean differences could reflect large changes in a few patients, small changes in many patients, or any combination of these outcomes. Determination of the proportion of patients who have a clinically important improvement in their pain would provide a more interpretable result with direct clinical implications. However, determining a clinically important outcome requires information about the degree of change over time that is clinically important. Data from the titration phase of a multiple cross-over randomized clinical trial of oral transmucosal fentanyl citrate (OTFC) for the treatment of cancer-related breakthrough pain were re-analyzed to examine the differences in pain scores between treatment episodes that did and did not yield adequate pain relief. The scales evaluated were absolute pain intensity difference (PID, 0-10 scale), percentage pain intensity difference (PID%, 0-100% scale), pain relief (PR, 0 (none), 1 (slight), 2 (moderate), 3 (lots), 4 (complete)), sum of the pain intensity difference (SPID over 60 min), percentage of maximum total pain relief (% Max TOTPAR over 60 min), and global medication performance (0 (poor), 1 (fair), 2 (good), 3 (very good), 4 (excellent)). Adequate relief was defined by the patient's decision not to use another dose of opioid medication as a rescue, in addition to the study medication, to treat each painful episode. One hundred thirty OTFC naive patients contributed data on 1268 episodes of breakthrough pain. The scales that were converted to a percentage change yielded the best accuracy in predicting adequate relief, with balanced sensitivity and specificity. The best cut-off point for both the % Max TOTPAR and the PID% was 33%. The best cut-off points for the absolute scales were absolute pain intensity difference of 2, pain relief of 2 (moderate), and SPID of 2. The global medication performance of 2 (good) had excellent values as well. This study presents data-derived cut-off points for the changes in several pain scales, each reflecting the clinically important improvement for patients treating breakthrough cancer pain episodes with OTFC. Confirmation in other patient populations and different pain syndromes will be needed. The use of consistent clinically important cut-off points as the primary outcome in future pain therapy clinical trials will enhance their validity, comparability, and clinical applicability.
- Published
- 2000
- Full Text
- View/download PDF
23. The effect of anesthetic technique on postoperative outcomes in hip fracture repair.
- Author
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O'Hara DA, Duff A, Berlin JA, Poses RM, Lawrence VA, Huber EC, Noveck H, Strom BL, and Carson JL
- Subjects
- Aged, Aged, 80 and over, Cohort Studies, Female, Hip Fractures mortality, Humans, Male, Middle Aged, Postoperative Complications epidemiology, Postoperative Complications mortality, Retrospective Studies, Treatment Outcome, Anesthesia, Conduction, Anesthesia, General, Hip Fractures surgery
- Abstract
Background: The impact of anesthetic choice on postoperative mortality and morbidity has not been determined with certainty., Methods: The authors evaluated the effect of type of anesthesia on postoperative mortality and morbidity in a retrospective cohort study of consecutive hip fracture patients, aged 60 yr or older, who underwent surgical repair at 20 US hospitals between 1983 and 1993. The primary outcome was defined as death within 30 days of the operative procedure. The secondary outcomes were postoperative 7-day mortality, postoperative myocardial infarction, postoperative pneumonia, postoperative congestive heart failure, and postoperative change in mental status. Numerous comorbid conditions were controlled for individually and by several comorbidity indices using logistic regression., Results: General anesthesia was used in 6,206 patients (65.8%) and regional anesthesia in 3,219 patients (3,078 spinal anesthesia and 141 epidural anesthesia). The 30-day mortality rate in the general anesthesia group was 4.4%, compared with 5.4% in the regional anesthesia group (unadjusted odds ratio = 0.80; 95% confidence interval = 0.66-0.97). However, the adjusted odds ratio for general anesthesia increased to 1.08 (0.84-1.38). The adjusted odds ratios for general anesthesia versus regional anesthesia for the 7-day mortality was 0.90 (0.59-1.39) and for postoperative morbidity outcomes were as follows: myocardial infarction: adjusted odds ratio = 1.17 (0.80-1.70); congestive heart failure: adjusted odds ratio = 1.04 (0.80-1.36); pneumonia: adjusted odds ratio = 1.21 (0.87-1.68); postoperative change in mental status: adjusted odds ratio = 1.08 (0.95-1.22)., Conclusions: The authors were unable to demonstrate that regional anesthesia was associated with better outcome than was general anesthesia in this large observational study of elderly patients with hip fracture. These results suggest that the type of anesthesia used should depend on factors other than any associated risks of mortality or morbidity.
- Published
- 2000
- Full Text
- View/download PDF
24. Screening for colorectal cancer and other GI cancers.
- Author
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Scotiniotis I, Lewis JD, and Strom BL
- Subjects
- Humans, Colorectal Neoplasms prevention & control, Gastrointestinal Neoplasms prevention & control, Mass Screening
- Abstract
Most of the major advances in the screening for gastrointestinal cancers this year were in the area of colorectal cancer screening. Currently, screening is recommended for the prevention of colorectal cancer in average and high-risk populations. For average risk populations, large randomized trials support the use of screening fecal occult blood testing, and case-control studies support the use of screening sigmoidoscopy. This year, several investigators have addressed issues related to the probability of identifying advanced lesions in the proximal colon following a positive screening flexible sigmoidoscopy. Similarly, two studies identified that villous histology in an index polyp was associated with an increased risk of recurrent colonic polyps. Additionally, two large trials provided new insight about the prevalence of mutations in the MLH1 or MSH2 mismatch-repair genes among patients with colorectal cancer. Lastly, a case-control study from Sweden provided the best evidence to date that surveillance colonoscopies for patients with long-standing ulcerative colitis may reduce cancer-related mortality. Although further work is needed, these studies have served to advance our knowledge of colorectal cancer screening substantially.
- Published
- 1999
- Full Text
- View/download PDF
25. The computer as a "living textbook" applied to the care of the critically injured patient.
- Author
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Siegel JH and Strom BL
- Subjects
- Humans, Interprofessional Relations, Referral and Consultation, Computers, Diagnosis, Computer-Assisted, Patient Care Planning, Wounds and Injuries therapy
- Published
- 1972
- Full Text
- View/download PDF
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