Search Results - "SOBEL, Rachel E"

Risk of carpal tunnel syndrome among patients with osteoarthritis: a US population-based study by Chen, Shuang, Ho, Tina, Asubonteng, Julius, Sobel, Rachel E, Eng, Simon, DiMartino, Stephen J, Manthripragada, Angelika

“…Carpal tunnel syndrome (CTS), an entrapment neuropathy caused by pressure of the median nerve, is a progressive condition that can lead to a decreased quality…”
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A web-based survey of UK pharmacists to assess the effectiveness of Viagra Connect® additional risk minimisation measures by Lem, Joanna, Collins, Janine, Maguire, Terry, Sobel, Rachel E.

“…Background To support reclassification in the UK of sildenafil citrate (50 mg) from prescription-only medicine to a pharmacy medicine (P status) under the…”
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A Novel Approach to Visualize Risk Minimization Effectiveness: Peeping at the 2012 UK Proton Pump Inhibitor Label Change Using a Rapid Cycle Analysis Tool by Sobel, Rachel E., Blackwell, William, Fram, David M., Bate, Andrew

“…Introduction Evaluation of risk minimization (RM) actions is an emerging area of regulatory science, often without tools to rapidly and systematically assess…”
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Regulatory and HTA Considerations for Development of Real‐World Data Derived External Controls by Curtis, Lesley H., Sola‐Morales, Oriol, Heidt, Julien, Saunders‐Hastings, Patrick, Walsh, Laura, Casso, Deborah, Oliveria, Susan, Mercado, Tiffany, Zusterzeel, Robbert, Sobel, Rachel E., Jalbert, Jessica J., Mastey, Vera, Harnett, James, Quek, Ruben G. W.

“…Regulators and Health Technology Assessment (HTA) bodies are increasingly familiar with, and publishing guidance on, external controls derived from real‐world…”
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Real World Evidence: Time for a Switch? by Sobel, Rachel E., Bate, Andrew, Reynolds, Robert F.

“…Real World Evidence provides critical information about the performance of medicines in routine clinical practice, as actually prescribed by physicians and…”
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Development and Validation of Claims‐Based Algorithms for Conjunctivitis and Keratitis by Chomistek, Andrea K., Franklin, Jessica M., Sobel, Rachel E., Marcus, Andrea F., Sinnott, Sarah‐Jo, Ezzy, Stephen M., Gately, Robert V., Green, Jeannette, Howell, Ashley, Sultan, Ihtisham, Akpek, Esen K., Wang, Florence T.

“…ABSTRACT Background Ocular surface disorders have been reported among patients with various medical conditions, including atopic dermatitis (AD). Nonetheless,…”
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Using EHR data to identify coronavirus infections in hospitalized patients: Impact of case definitions on disease surveillance by Navar, Ann Marie, Cosmatos, Irene, Purinton, Stacey, Ramsey, Janet L., Taylor, Robert J., Sobel, Rachel E., Barlow, Ginger, Dieck, Gretchen S., Bulgrein, Michael L., Peterson, Eric D.

“…•The number of cases identified with COVID-19 varies approximately twofold depending on whether laboratory confirmation is required in the EHR.•There is…”
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The utility of real‐world evidence for benefit‐risk assessment, communication, and evaluation of pharmaceuticals: Case studies by Radawski, Christine A., Hammad, Tarek A., Colilla, Susan, Coplan, Paul, Hornbuckle, Kenneth, Freeman, Emily, Smith, Meredith Y., Sobel, Rachel E., Bahri, Priya, Arias, Ariel E., Bennett, Dimitri

“…Purpose In recent years, novel types of real‐world evidence (RWE) have played a role in various decision‐making processes relating to medicinal products,…”
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A long-term, prospective, observational cohort study of the safety and effectiveness of etanercept for the treatment of patients with paediatric psoriasis in a naturalistic setting by Gu, Yun, Brinkley, Emma, Largent, Joan, Sobel, Rachel E., Colli, Sara, Thaçi, Diamant, Seyger, Marieke, Szalai, Zsuzsanna, Lacour, Jean-Philippe, Ståhle, Mona

“…Background Psoriasis is a chronic inflammatory skin disorder that affects 125 million people worldwide, with one-third having childhood onset. Objectives The…”
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Computer-assisted expert case definition in electronic health records by Walker, Alexander M, Zhou, Xiaofeng, Ananthakrishnan, Ashwin N, Weiss, Lisa S, Shen, Rongjun, Sobel, Rachel E, Bate, Andrew, Reynolds, Robert F

“…Highlights • Computer-supported presentation of cases and prior classification rules can elicit machine-implementable case definitions from clinical experts. •…”
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Evaluation of the Effectiveness of Additional Risk Minimization Measures for Voriconazole in the EU: Findings and Lessons Learned from a Healthcare Professional Survey by Lem, Joanna, Younus, Muhammad, Aram, Jalal A., Moosavi, Shahrzad, Freivogel, Klaus, Lewis, Anne, Sobel, Rachel E.

“…Background Voriconazole is an extended-spectrum antifungal agent approved for the treatment and prophylaxis of invasive aspergillosis and other serious fungal…”
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Do FDA label changes work? Assessment of the 2010 class label change for proton pump inhibitors using the Sentinel System's analytic tools by Sobel, Rachel E., Bate, Andrew, Marshall, James, Haynes, Kevin, Selvam, Nandini, Nair, Vinit, Daniel, Gregory, Brown, Jeffrey S., Reynolds, Robert F.

“…Purpose To pilot use of the US Food and Drug Administration's (FDA's) Sentinel System data and analytic tools by a non‐FDA stakeholder through the Innovation…”
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PB2357: TRIAL IN PROGRESS: OUTCOMES IN PATIENTS WITH RELAPSED/REFRACTORY DIFFUSE LARGE B‐CELL LYMPHOMA TREATED WITH SYSTEMIC THERAPY FROM REAL‐WORLD EXPERIENCE (ORCHID) by Thieblemont, Catherine, MA, Qiufei, Hampp, Christian, Harnett, James, Sobel, Rachel E, Jalbert, Jessica J, Quek, Ruben Gw, Wei, Wenhui, Wu, Ning, Mastey, Vera, Wang, Joy, Bajwa, Anit, Maissenhaelter, Benedikt, Gils, Chantal, Aggarwal, Shivani, Chaudhry, Aafia, Mohamed, Hesham, Ambati, Srikanth, Bachy, Emmanuel, Damaj, Gandhi Laurent

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PB2281: TRIAL IN PROGRESS: FOLLICULAR LYMPHOMA OUTCOMES IN RELAPSED/REFRACTORY PATIENTS TREATED WITH SYSTEMIC THERAPY IN A REAL‐WORLD ASSESSMENT (FLORA) by Damaj, Gandhi Laurent, Bachy, Emmanuel, MA, Qiufei, Hampp, Christian, Harnett, James, Sobel, Rachel E, Jalbert, Jessica J, Quek, Ruben Gw, Wei, Wenhui, Wu, Ning, Mastey, Vera, Wang, Joy, Bajwa, Anit, Maissenhaelter, Benedikt, Gils, Chantal, Aggarwal, Shivani, Chaudhry, Aafia, Mohamed, Hesham, Ambati, Srikanth, Thieblemont, Catherine

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Monitoring the long‐term safety of therapies for children with juvenile idiopathic arthritis: Time for a consolidated patient registry by Smith, Meredith Y., Sobel, Rachel E., Wallace, Carol A.

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Current needs in pediatric pharmacoepidemiology by Lasky, Tamar, Artaman, Al, Czaja, Angela S., Maruti, Sonia S., Osokogu, Osemeke U., Verhamme, Katia M.C., Sobel, Rachel E.

“…Purpose We report on a needs assessment conducted by the International Society of Pharmacoepidemiology (ISPE) Pediatric Special Interest Group (SIG) to…”
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Using registries to identify adverse events in rheumatic diseases by Lionetti, Geraldina, Kimura, Yukiko, Schanberg, Laura E, Beukelman, Timothy, Wallace, Carol A, Ilowite, Norman T, Winsor, Jane, Fox, Kathleen, Natter, Marc, Sundy, John S, Brodsky, Eric, Curtis, Jeffrey R, Del Gaizo, Vincent, Iyasu, Solomon, Jahreis, Angelika, Meeker-O'Connell, Ann, Mittleman, Barbara B, Murphy, Bernard M, Peterson, Eric D, Raymond, Sandra C, Setoguchi, Soko, Siegel, Jeffrey N, Sobel, Rachel E, Solomon, Daniel, Southwood, Taunton R, Vesely, Richard, White, Patience H, Wulffraat, Nico M, Sandborg, Christy I

“…The proven effectiveness of biologics and other immunomodulatory products in inflammatory rheumatic diseases has resulted in their widespread use as well as…”
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A Case Study of the Incremental Utility for Disease Identification of Natural Language Processing in Electronic Medical Records by Weiss, Lisa S., Zhou, Xiaofeng, Walker, Alexander M., Ananthakrishnan, Ashwin N., Shen, Rongjun, Sobel, Rachel E., Bate, Andrew, Reynolds, Robert F.

“…Background Information exists as unstructured medical text in healthcare databases. Such information is not routinely considered in safety surveillance but…”
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Novel Method to Collect Medication Adverse Events in Juvenile Arthritis: Results From the Childhood Arthritis and Rheumatology Research Alliance Enhanced Drug Safety Surveillance Project by Ringold, Sarah, Hendrickson, Audrey, Abramson, Leslie, Beukelman, Timothy, Blier, Peter R., Bohnsack, John, Chalom, Elizabeth C., Gewanter, Harry L., Gottlieb, Beth, Hollister, Roger, Hsu, Joyce, Hudgins, Andrea, Ilowite, Norman T., Klein‐Gitelman, Marisa, Lindsley, Carol, Lopez Benitez, Jorge M., Lovell, Daniel J., Mason, Tom, Milojevic, Diana, Moorthy, Lakshmi N., Nanda, Kabita, Onel, Karen, Prahalad, Sampath, Rabinovich, C. Egla, Ray, Linda, Rouster‐Stevens, Kelly, Ruth, Natasha, Shishov, Michael, Spalding, Steven, Syed, Reema, Stoll, Matthew, Vehe, Richard K., Weiss, Jennifer E., White, Andrew J., Wallace, Carol A., Sobel, Rachel E.

“…Objective Few data are available regarding the rates of serious adverse events (SAEs) and important medical events (IMEs) outside of product‐based registries…”
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Safety of celecoxib and nonselective nonsteroidal anti-inflammatory drugs in juvenile idiopathic arthritis: results of the Phase 4 registry by Sobel, Rachel E, Lovell, Daniel J, Brunner, Hermine I, Weiss, Jennifer E, Morris, Paula W, Gottlieb, Beth S, Chalom, Elizabeth C, Jung, Lawrence K, Onel, Karen B, Petiniot, Lisa, Goldsmith, Donald P, Nanda, Kabita, Shishov, Michael, Abramsky, Staci, Young, James P, Giannini, Edward H

“…This study aimed to assess long-term safety and developmental data on juvenile idiopathic arthritis (JIA) patients treated in routine clinical practice with…”
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