Search Results - "Pharmacoepidemiology and drug safety"

The national healthcare system claims databases in France, SNIIRAM and EGB: Powerful tools for pharmacoepidemiology by Bezin, Julien, Duong, Mai, Lassalle, Régis, Droz, Cécile, Pariente, Antoine, Blin, Patrick, Moore, Nicholas

“…The French health care system is based on universal coverage by one of several health care insurance plans. The SNIIRAM database merges anonymous information…”
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The Chang Gung Research Database—A multi‐institutional electronic medical records database for real‐world epidemiological studies in Taiwan by Shao, Shih‐Chieh, Chan, Yuk‐Ying, Kao Yang, Yea‐Huei, Lin, Swu‐Jane, Hung, Ming‐Jui, Chien, Rong‐Nan, Lai, Chi‐Chun, Lai, Edward Chia‐Cheng

“…Purpose The Chang Gung Research Database (CGRD), the largest multi‐institutional electronic medical records (EMR) collection in Taiwan, provides good access…”
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Trial designs using real‐world data: The changing landscape of the regulatory approval process by Baumfeld Andre, Elodie, Reynolds, Robert, Caubel, Patrick, Azoulay, Laurent, Dreyer, Nancy A.

“…Purpose There is a need to develop hybrid trial methodology combining the best parts of traditional randomized controlled trials (RCTs) and observational study…”
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A synthesis of oral morphine equivalents (OME) for opioid utilisation studies by Nielsen, Suzanne, Degenhardt, Louisa, Hoban, Bianca, Gisev, Natasa

“…Purpose Oral Morphine Equivalent (OME) doses are increasingly being used as a metric to represent opioid use. Driven by a growing need from…”
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Good practices for real‐world data studies of treatment and/or comparative effectiveness: Recommendations from the joint ISPOR‐ISPE Special Task Force on real‐world evidence in health care decision making by Berger, Marc L., Sox, Harold, Willke, Richard J., Brixner, Diana L., Eichler, Hans‐Georg, Goettsch, Wim, Madigan, David, Makady, Amr, Schneeweiss, Sebastian, Tarricone, Rosanna, Wang, Shirley V., Watkins, John, Daniel Mullins, C.

“…Purpose Real‐world evidence (RWE) includes data from retrospective or prospective observational studies and observational registries and provides insights…”
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Use of real‐world evidence in regulatory decisions for rare diseases in the United States—Current status and future directions by Wu, Jasmanda, Wang, Cunlin, Toh, Sengwee, Pisa, Federica Edith, Bauer, Larry

“…Following the release of the framework for the Real‐World Evidence (RWE) Program, the US Food and Drug Administration (FDA) is actively evaluating and…”
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Validation of the national health insurance research database with ischemic stroke cases in Taiwan by Cheng, Ching-Lan, Kao, Yea-Huei Yang, Lin, Swu-Jane, Lee, Cheng-Han, Lai, Ming Liang

“…Objective The National Health Insurance Research Database (NHIRD) is commonly used for pharmacoepidemiological research in Taiwan. This study evaluated the…”
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Prevalent new‐user cohort designs for comparative drug effect studies by time‐conditional propensity scores by Suissa, Samy, Moodie, Erica E. M., Dell'Aniello, Sophie

“…Purpose Studies of the real‐world comparative effectiveness of drugs conducted using computerized healthcare databases typically involve an incident new‐user…”
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Time‐related biases in pharmacoepidemiology by Suissa, Samy, Dell'Aniello, Sophie

“…Purpose Observational studies using computerized healthcare databases have become popular to investigate the potential effectiveness of old drugs for new…”
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Real‐world evidence to support regulatory decision‐making for medicines: Considerations for external control arms by Burcu, Mehmet, Dreyer, Nancy A., Franklin, Jessica M., Blum, Michael D., Critchlow, Cathy W., Perfetto, Eleanor M., Zhou, Wei

“…Randomized clinical trials (RCTs) are the gold standard in producing clinical evidence of efficacy and safety of medical interventions. More recently, a new…”
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Accuracy of Japanese claims data in identifying diabetes‐related complications by Fujihara, Kazuya, Yamada‐Harada, Mayuko, Matsubayashi, Yasuhiro, Kitazawa, Masaru, Yamamoto, Masahiko, Yaguchi, Yuta, Seida, Hiroyasu, Kodama, Satoru, Akazawa, Kohei, Sone, Hirohito

“…Purpose To evaluate the accuracy of various claims‐based definitions of diabetes‐related complications (coronary artery disease [CAD], heart failure,…”
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Use of real‐world evidence from healthcare utilization data to evaluate drug safety during pregnancy by Huybrechts, Krista F., Bateman, Brian T., Hernández‐Díaz, Sonia

“…Purpose Because preapproval clinical trials typically exclude pregnant women, the evidence on drug safety during pregnancy required to inform drug labeling…”
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Long‐term opioid therapy definitions and predictors: A systematic review by Karmali, Ruchir N., Bush, Christopher, Raman, Sudha R., Campbell, Cynthia I., Skinner, Asheley C., Roberts, Andrew W.

“…Purpose This review sought to (a) describe definitions of long‐term opioid therapy (LTOT) outcome measures, and (b) identify the predictors associated with the…”
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Reporting to Improve Reproducibility and Facilitate Validity Assessment for Healthcare Database Studies V1.0 by Wang, Shirley V., Schneeweiss, Sebastian, Berger, Marc L., Brown, Jeffrey, Vries, Frank, Douglas, Ian, Gagne, Joshua J., Gini, Rosa, Klungel, Olaf, Mullins, C. Daniel, Nguyen, Michael D., Rassen, Jeremy A., Smeeth, Liam, Sturkenboom, Miriam, Berger, Marc L., Brown, Jeffrey, Vries, Frank, Douglas, Ian, Gagne, Joshua J., Gini, Rosa, Klungel, Olaf, Mullins, C. Daniel, Nguyen, Michael D., Rassen, Jeremy A., Smeeth, Liam, Sturkenboom, Miriam, Bate, Andrew, Bourke, Alison, Cadarette, Suzanne, Gerhard, Tobias, Glynn, Robert, Huybrechts, Krista, Kubota, Kiyoshi, Makady, Amr, Nyberg, Fredrik, Ritchey, Mary E., Rothman, Ken, Toh, Sengwee

“…Purpose Defining a study population and creating an analytic dataset from longitudinal healthcare databases involves many decisions. Our objective was to…”
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One-to-many propensity score matching in cohort studies by Rassen, Jeremy A., Shelat, Abhi A., Myers, Jessica, Glynn, Robert J., Rothman, Kenneth J., Schneeweiss, Sebastian

“…ABSTRACT Background Among the large number of cohort studies that employ propensity score matching, most match patients 1:1. Increasing the matching ratio is…”
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Characteristics and external validity of the German Health Risk Institute (HRI) Database by Andersohn, Frank, Walker, Jochen

“…Purpose The aim of this study was to describe characteristics and external validity of the German Health Risk Institute (HRI) Database. Methods The HRI…”
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Methods for time‐varying exposure related problems in pharmacoepidemiology: An overview by Pazzagli, Laura, Linder, Marie, Zhang, Mingliang, Vago, Emese, Stang, Paul, Myers, David, Andersen, Morten, Bahmanyar, Shahram

“…Purpose Lack of control for time‐varying exposures can lead to substantial bias in estimates of treatment effects. The aim of this study is to provide an…”
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Validity of cancer diagnosis in the National Health Insurance database compared with the linked National Cancer Registry in Taiwan by Kao, Wei‐Heng, Hong, Ji‐Hong, See, Lai‐Chu, Yu, Huang‐Ping, Hsu, Jun‐Te, Chou, I‐Jun, Chou, Wen‐Chi, Chiou, Meng‐Jiun, Wang, Chun‐Chieh, Kuo, Chang‐Fu

“…Purpose We aimed to evaluate the validity of cancer diagnosis in the National Health Insurance (NHI) database, which has routinely collected the health…”
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Core concepts in pharmacoepidemiology: Confounding by indication and the role of active comparators by Sendor, Rachel, Stürmer, Til

“…Confounding by indication poses a significant threat to the validity of nonexperimental studies assessing effectiveness and safety of medical interventions…”
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Improving transparency to build trust in real‐world secondary data studies for hypothesis testing—Why, what, and how: recommendations and a road map from the real‐world evidence transparency initiative by Orsini, Lucinda S., Monz, Brigitta, Mullins, C. Daniel, Van Brunt, David, Daniel, Gregory, Eichler, Hans‐Georg, Graff, Jennifer, Guerino, John, Berger, Marc, Lederer, Nirosha M., Jonsson, Pall, Schneeweiss, Sebastian, Wang, Shirley V., Crown, William, Goettsch, Wim, Willke, Richard J.

“…Real‐world data (RWD) and the derivations of these data into real‐world evidence (RWE) are rapidly expanding from informing healthcare decisions at the patient…”
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