Now showing items 1-20 of 1006

    • Incompletely Reported Important Methodological Details and Inaccurate Description of the Formulation That the Control Arms Received in a Gardasil Vaccine Trial

      Bourgeois, Florence; Doshi, Peter; Hong, Kyungwan; Jefferson, Tom; Jones, Mark; Lee, Haeyoung; Rowhani-Farid, Anisa; Shamseer, Larissa; Spence, O'Mareen (American Society for Microbiology, 2020-11-04)
    • Covid-19 vaccine trial protocols released

      Doshi, Peter (BMJ Publishing Group, 2020-10-21)
    • Maryland Poison Center Annual Report 2019

      University of Maryland, Baltimore. Maryland Poison Center, 2019
    • Comparative effectiveness of pediatric and neonatal antimicrobial stewardship treatment algorithms in rapid diagnostic-detected bacteremia

      Kruger Howard, Amy; Claeys, Kimberly; Parbuoni, Kristine A.; Biggs, Jessica M.; Johnson, J. Kristie; Luneburg, Paige; Campbell, James D.; Morgan, Jill A. (2020-04)
    • Acceptance of medication - sweetness wins again

      Kruger Howard, Amy; Morgan, Jill A.; Selen, Arzu; Seung, Hyunuk; Ibrahim, Ahmed; Sayeed, Vilayat; Siddiqui, Akhtar; Hollenbeck, R. Gary; Hoag, Stephen W. (2019-09)
    • Impact of pharmacist patient education on asthma control

      Kruger Howard, Amy; Tsoukleris, Mona; Morgan, Jill A.; Seung, Hyunuk (2018-03)
    • Branching out: can satellite campus students lead the way?

      Rocafort, Patrick Tim; Morgan, Jill A.; Lebovitz, Lisa (2017-07)
    • For a satellite campus, is a residency a foul ball or home run?

      Rocafort, Patrick Tim; Morgan, Jill A.; Lebovitz, Lisa (2017-07)
    • Bivalirudin Use in Pediatric Patients

      Daniel, Shawnée N.; Parbuoni, Kristine A.; Kishk, Omayma A.; Morgan, Jill A.; Brown, Claudine; Walker, L. Kyle (2020-09-25)
    • Incidence of administration of QT-prolonging medications in pediatric patients

      Callaghan, Katelyn; Parbuoni, Kristine A.; Morgan, Jill A.
    • Covid-19: Do many people have pre-existing immunity?

      Doshi, Peter (BMJ Publishing Group, 2020-09-17)
    • Covid-19: Should doctors recommend treatments and vaccines when full data are not publicly available?

      Johnson, Raymond M.; Doshi, Peter; Healy, David, 1954- (BMJ, 24/08/2020)
    • Mapping Expanded Prostate Cancer Index Composite (EPIC) Questionnaire to EuroQoL-5D (EQ-5D) Utility Weights to Inform Economic Evaluations for Prostate Cancer

      Khairnar, Rahul; Palumbo, Francis Bernard, 1945- (2020)
      OBJECTIVES: To develop a mapping algorithm to obtain EuroQoL-5D-3L (EQ5D) health utilities from Expanded Prostate Cancer Index Composite (EPIC) questionnaire. METHODS: This mapping study utilized baseline data from an international, multicenter, randomized controlled trial (NCT00331773) of patients with low-risk prostate cancer. Patient health-related quality-of-life (HRQoL) data were collected using EPIC and health utilities were obtained using EQ5D. Data were divided into an estimation sample (n=765, 70%) and a validation sample (n=327, 30%). The relationship between the instruments was estimated using ordinary least squares (OLS), Tobit, and two-part models. Five-fold cross-validation (in-sample) was used to compare the predictive performance of the estimated models. Final models were selected based on root mean square error (RMSE). OLS models using baseline cross-sectional data, combined data from all assessment periods, and random effects (RE) models that explicitly model the longitudinal nature of the data were estimated to compare predictive ability of algorithms derived from cross-sectional and longitudinal data. Longitudinal predictive performance of OLS models derived using baseline data was examined in the post-intervention data. RESULTS: A total of 565 patients in the estimation sample had complete information on both EPIC and EQ5D questionnaires at baseline. Mean observed EQ5D utility was 0.90±0.13 (range: 0.28-1) with 55% of patients in full health. Low to moderate correlations were found between EQ5D utility and urinary (r=0.38), bowel (r=0.34) and hormonal (r=0.55) domains of EPIC; sexual domain was weakly correlated (r=0.18) with EQ5D utility. OLS models outperformed their counterpart models for all pre-determined model specifications. The best model fit was: “EQ5D utility = 0.248541 + 0.000748*(Urinary Function) + 0.001134*(Urinary Bother) + 0.000968*(Hormonal Function) + 0.004404*(Hormonal Bother) – 0.376487*(Zubrod) + 0.003562*(Urinary Function*Zubrod)”; RMSE was 0.10462. When comparing cross-sectional vs. longitudinal data, a mapping algorithm obtained using combined EPIC subdomain data outperformed other model types. Mean absolute differences (MDs) between reported and predicted were low in general and decreased as the time of assessment increased. CONCLUSIONS: This study identified mapping algorithms to generate EQ5D utilities from EPIC domain or sub-domain scores, with satisfactory longitudinal predictive performance. The study results will help estimate quality-adjusted life-years in future economic evaluations of prostate cancer treatments.
    • Early Symptom Improvement as a Predictor of Antidepressant Response in Children and Adolescents Diagnosed with Depression: Translating Evidence from Randomized Controlled Trials to Community Practice

      Spence, O'Mareen; dosReis, Susan (2020)
      Statement of the Problem: A common problem among children and adolescents diagnosed with depression who receive care in community settings is that antidepressant regimen changes such as psychotropic augmentation may occur soon after starting treatment. This raises the question as to whether such changes are implemented among youth who would otherwise respond to the antidepressant. Thus, the overarching objectives of this dissertation were to 1) distinguish early in treatment children and adolescents who are likely to respond, and 2) empirically evaluate the association between predicted response and psychotropic augmentation or switching in real world settings. Summary of Methods: Using randomized clinical trial (RCT) data, this research applied a Bayesian approach to predict the likelihood of initial (12 week) and sustained (18 week) response to treatment as a function of early changes in depressive symptoms (i.e. mood, somatic, subjective and behavioral) and other demographic and clinical factors. An innovative application of combined sample multiple imputations (CSMI) was used to estimate the 12-week predicted probability of response among commercially insured adolescents who received care in real-world settings. Each adolescent received a probability of treatment response, which was then used to compare the odds of psychotropic augmentation or switch. Results: Early changes in mood and somatic symptoms within the first six weeks of treatment are primary predictors of initial (at 12 weeks) and sustained (at 18 weeks) response to an antidepressant. Baseline depression severity is an important prognostic factor for initial response, and additional, though minimal improvement, in somatic symptoms from weeks 6 to 12 is indicative of sustained response. In a highly selected cohort of adolescents receiving care in community settings, an augmentation or switch occurred similarly among adolescents with a high versus low likelihood of responding to fluoxetine. Conclusion: The results suggest that other factors beyond expected antidepressant response (or lack thereof) might influence current treatment practices. Our findings have clinical and public health implications that support measurement-based care in pediatric depression. Our application of CSMI highlights several key areas of consideration for future pharmacoepidemiologic research aimed at translating RCT evidence to real world data to better understand clinical practices patterns.
    • A Model for Assessing Professional Association Engagement

      Gorman, Emily; Jackson, K. D.; Harrold, M.W.; Mercer, S.L.; Metcalf, M.; Lebovitz, Lisa; Tucker, Shannon R.; Block, K.F.; Franzini, R.; Coop, Andrew (2020)
      Assessing member engagement with a professional association is critical in determining the success of programs such as the AACP New Investigator Award (NIA), because engagement leads to organizational growth and is key to long term sustainability. A review of the literature indicated that many organizations are focused on increasing engagement, but there are few quantifications of engagement to be used to measures success of initiatives. Use of online communication tools such as AACP Connect can be quantified, and are often used as a proxy for engagement, but the literature is clear that the majority of individuals may be avid readers, but do not post. The authors searched peer-reviewed and organizational literature for published models evaluating organizational engagement to create a modified scale to quantify engagement following the NIA. The American Bar Association published an article assessing engagement of its members with five tiers, explaining the tiers as a continuum. Although presented by ABA as a continuum, this approach was seen by the authors as an approach to measure the depth of engagement.
    • Follicular Lymphoma Stage at Diagnosis: Determinants, Prediction from Administrative Claims Data and Impact on Healthcare Costs

      Albarmawi, Husam; Onukwugha, Eberechukwu (2020)
      Introduction: Follicular lymphoma (FL) stage is an important determinant of survival, treatment options and treatment outcomes. However, the determinants of advanced FL, defined as Ann Arbor stages III and IV, and its impact on the economic burden of FL are unknown. Moreover, for studies that rely on administrative claims data, it is not clear if advanced FL can be accurately predicted from this data source. Methods: Using the linked Surveillance, Epidemiology, and End Results-Medicare database we identified patients newly diagnosed with FL. We estimated a modified Poisson regression to explore the effect of pre-diagnosis healthcare resource utilization patterns and baseline county-level factors on FL stage. We estimated the 1-year and 5-year incremental costs of stages II-IV compared to stage I using generalized linear models. To predict FL stage from claims data, we developed and tested two random forests models. Results: We identified 11,078 patients diagnosed in 2000-2013. Half of the sample had advanced FL. Higher counts of specialist physician visits in the 3 years pre-diagnosis were associated with lower risk of advanced FL (4th quartile vs. 1st quartile: Relative Risk [RR]=0.92; 95% CI=0.86–0.99). The risk of advanced FL was 8% lower among women receiving screening mammography compared to men (RR=0.92; 95% CI=0.88–0.97). Living in counties designated as health professional shortage areas (HPSA) was associated with 7% increased risk of advanced FL (RR=1.07; 95% CI=1.00–1.14, p=0.049). In 2004-2009, FL patients with stages II, III and IV had statistically higher 1-year ($14,911; $15,106; $24,639, respectively, p<0.01) and 5-year costs ($21,590; $23,599; $34,968, respectively, p<0.01) compared to stage I patients. The random forests models exhibited poor accuracy of classifying limited and advanced FL from Medicare claims data (accuracy: ≤64%; sensitivity: ≤72%; specificity: ≤57%). Conclusions: Higher frequencies of specialist physician visits and living in counties with no HPSA can reduce the risk of presenting with advanced FL. Patients with stages II-IV incur significantly higher costs compared to stage I patients. The incremental cost increases with higher FL stage. Predicting advanced FL from claims data may not be feasible and researchers may need to rely on datasets with existing clinical information.
    • Effect of Transient Heat Exposure on Drug Delivery from Transdermal and Topical Products

      Thomas, Sherin; Stinchcomb, Audra L. (2020)
      Heating pads and electric blankets are widely used for relief from pain and to provide warmth, respectively. Their unintentional application simultaneously with a transdermal or topical system can result in unexpected drug levels in systemic circulation. Designing well-characterized in vitro and in vivo methods are vital to understanding the effect of heat and hence can aid in the development and evaluation of these products. The objective of this work was to evaluate the effect of heat on products with the same active pharmaceutical ingredient (API) but different inactive ingredients. Four drug molecules with different physicochemical properties were chosen. For each drug, formulations with different excipients were selected. In vivo serum drug profile and in vitro flux profile data can provide mechanistic understanding of heat effect on these formulations. Four topical diclofenac formulations were evaluated for heat effect in vitro under continuous heat exposure. Their flux profiles demonstrated the influence of formulation design and excipients on drug permeation at elevated skin temperature. Serum profiles of two different oxybutynin formulations evaluated under heat exposure showed very different magnitude of enhancement in serum levels under similar heat exposure conditions. Another objective of this work was establishing an in vitro - in vivo correlation (IVIVC) of heat effect on topical and transdermal formulations. This will help in characterizing and predicting heat effect minimizing the need of clinical trials and support the regulatory evaluation of these dosage forms. For buprenorphine patch, study design for in vitro permeation testing (IVPT) using human skin was well characterized to align with and mimic in vivo conditions of heat exposure. Level A and Level C IVIVC were established under normal as well as elevated temperature conditions. For lidocaine patches, IVIVC was observed for early heat effect. However, poor correlation was observed for late heat effect. The findings from this work determined IVPT studies can correlate with and be predictive of in vivo results under normal temperature conditions. But under suboptimal conditions like heat exposure, IVPT may have limitations and should be used in addition to other methods to evaluate heat effect.