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4341por Rajkomar, Alvin, Oren, Eyal, Chen, Kai, Dai, Andrew M., Hajaj, Nissan, Hardt, Michaela, Liu, Peter J., Liu, Xiaobing, Marcus, Jake, Sun, Mimi, Sundberg, Patrik, Yee, Hector, Zhang, Kun, Zhang, Yi, Flores, Gerardo, Duggan, Gavin E., Irvine, Jamie, Le, Quoc, Litsch, Kurt, Mossin, Alexander, Tansuwan, Justin, Wang, De, Wexler, James, Wilson, Jimbo, Ludwig, Dana, Volchenboum, Samuel L., Chou, Katherine, Pearson, Michael, Madabushi, Srinivasan, Shah, Nigam H., Butte, Atul J., Howell, Michael D., Cui, Claire, Corrado, Greg S., Dean, Jeffrey“…We demonstrate that deep learning methods using this representation are capable of accurately predicting multiple medical events from multiple centers without site-specific data harmonization. We validated our approach using de-identified EHR data from two US academic medical centers with 216,221 adult patients hospitalized for at least 24 h. …”
Publicado 2018
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4342por Shin, Youngbin, Kim, Kyung Won, Lee, Amy Junghyun, Sung, Yu Sub, Ahn, Suah, Koo, Ja Hwan, Choi, Chang Gyu, Ko, Yousun, Kim, Ho Sung, Park, Seong Ho“…METHODS: Key regulatory requirements of CTIMS were extracted thorough review of many related regulations and guidelines including International Conference on Harmonization-GCP E6, FDA 21 Code of Federal Regulations parts 11 and 820, Good Automated Manufacturing Practice, and Clinical Data Interchange Standards Consortium. …”
Publicado 2019
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4343por Kulpa-Eddy, Jodie, Srinivas, Geetha, Halder, Marlies, Hill, Richard, Brown, Karen, Roth, James, Draayer, Hans, Galvin, Jeffrey, Claassen, Ivo, Gifford, Glen, Woodland, Ralph, Doelling, Vivian, Jones, Brett, Stokes, William S“…Workshop participants recommended enhanced international harmonization and cooperation and closer collaborations between human and veterinary researchers to expedite progress. …”
Publicado 2011
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4344por Fosam, Andin, Grewal, Shivraj, Armiyaw, Abdul-Latif, Sarcone, Camila, Rabel, Antoinette, Auh, Sungyoung, Muniyappa, Ranganath“…Lack of standardization and harmonization of insulin assays limit the clinical use of insulin-based surrogate indexes of insulin resistance. …”
Publicado 2020
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4345“…However, as discussed in prior studies comparing the performance of common prolactin immunoassays in a reference population of both males and females with and without known hyperprolactinemia or macroprolactinemia, there has been poor harmonization between assays and variable reactivity towards macroprolactin, resulting in significantly different normal ranges for total and monomeric prolactin between manufacturers. …”
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4346por Timmers, Marjolein, van Dijck, Jeroen T. J. M., van Wijk, Roel P. J., Legrand, Valerie, van Veen, Ernest, Maas, Andrew I. R., Menon, David K., Citerio, Giuseppe, Stocchetti, Nino, Kompanje, Erwin J. O.“…BACKGROUND: The European Union (EU) aims to optimize patient protection and efficiency of health-care research by harmonizing procedures across Member States. Nonetheless, further improvements are required to increase multicenter research efficiency. …”
Publicado 2020
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4347por Vallot, Delphine, De Ponti, Elena, Morzenti, Sabrina, Gramek, Anna, Pieczonka, Anna, Llompart, Gabriel Reynés, Siennicki, Jakub, Deak, Paul, Dutta, Chiranjib, Uribe, Jorge, Caselles, Olivier“…INTRODUCTION: Quantitative imaging biomarkers are becoming usual in oncology for assessing therapy response. The harmonization of image quantitation reporting has become of utmost importance due to the multi-center trials increase. …”
Publicado 2020
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4348por Odei-Lartey, Eliezer Ofori, Prah, Rebecca Kyerewaa Dwommoh, Anane, Edward Apraku, Danwonno, Harry, Gyaase, Stephaney, Oppong, Felix Boakye, Afenyadu, Godwin, Asante, Kwaku Poku“…Ghana has deployed DHIMS2 to replace the previously existing manual data harmonization processes. METHODS: This cross-sectional study was conducted in 12 districts comprising 12 district directorates, 10 district hospitals, 29 sub-district health centers, and 38 community health facilities in the Brong-Ahafo Region. …”
Publicado 2020
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4349por Loria, Guido Ruggero, Ruocco, Luigi, Ciaccio, Gabriele, Iovino, Francesco, Nicholas, Robin A. J., Borrello, Silvio“…ABSTRACT: After almost 40 years, the 27 member states (MS) of the European Union (EU) will comply with the European Law 429/2016 in 2021 by completing a process of unification and harmonization of all regulations related to animal health between MS. …”
Publicado 2020
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4350“…The results of this review may contribute to the development of practice-oriented minimal standards for the governance of data access, which could also result in a stronger harmonization, efficiency, and effectiveness of CDW.…”
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4351por Veldhuijzen, Evalien, Walraven, Iris, Mitchell, Sandra A., Moore, Elizabeth Yohe, McKown, Shawn M., Lauritzen, Matthew, Kim, Katherine J., Belderbos, José S. A., Aaronson, Neil K.“…METHODS: All 124 items in the PRO-CTCAE item library were translated into Dutch using established translation procedures, including dual forward translations, reconciliation, back-translation, reconciliation of the source with the back-translation, and expert reviews. Harmonization of the translation for use in both the Netherlands and Belgium was achieved via an iterative review process in which the translations were discussed and reconciled by consensus of PRO experts, clinicians and bilingual Dutch translators. …”
Publicado 2020
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4352por Hess, Jeremy J., Ranadive, Nikhil, Boyer, Chris, Aleksandrowicz, Lukasz, Anenberg, Susan C., Aunan, Kristin, Belesova, Kristine, Bell, Michelle L., Bickersteth, Sam, Bowen, Kathryn, Burden, Marci, Campbell-Lendrum, Diarmid, Carlton, Elizabeth, Cissé, Guéladio, Cohen, Francois, Dai, Hancheng, Dangour, Alan David, Dasgupta, Purnamita, Frumkin, Howard, Gong, Peng, Gould, Robert J., Haines, Andy, Hales, Simon, Hamilton, Ian, Hasegawa, Tomoko, Hashizume, Masahiro, Honda, Yasushi, Horton, Daniel E., Karambelas, Alexandra, Kim, Ho, Kim, Satbyul Estella, Kinney, Patrick L., Kone, Inza, Knowlton, Kim, Lelieveld, Jos, Limaye, Vijay S., Liu, Qiyong, Madaniyazi, Lina, Martinez, Micaela Elvira, Mauzerall, Denise L., Milner, James, Neville, Tara, Nieuwenhuijsen, Mark, Pachauri, Shonali, Perera, Frederica, Pineo, Helen, Remais, Justin V., Saari, Rebecca K., Sampedro, Jon, Scheelbeek, Pauline, Schwartz, Joel, Shindell, Drew, Shyamsundar, Priya, Taylor, Timothy J., Tonne, Cathryn, Van Vuuren, Detlef, Wang, Can, Watts, Nicholas, West, J. Jason, Wilkinson, Paul, Wood, Stephen A., Woodcock, James, Woodward, Alistair, Xie, Yang, Zhang, Ying, Ebi, Kristie L.“…DISCUSSION: This checklist provides guidance for conducting and reporting HEM estimates to make them more comparable and useful for policymakers. Harmonization of HEM estimates has the potential to lead to advances in and improved synthesis of policy-relevant research that can inform evidence-based decision making and practice. https://doi.org/10.1289/EHP6745…”
Publicado 2020
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4353por Murray, Daniel D., Babiker, Abdel G., Baker, Jason V., Barkauskas, Christina E., Brown, Samuel M., Chang, Christina C., Davey, Victoria J., Gelijns, Annetine C., Ginde, Adit A., Grund, Birgit, Higgs, Elizabeth, Hudson, Fleur, Kan, Virginia L., Lane, H. Clifford, Murray, Thomas A., Paredes, Roger, Parmar, Mahesh K.B., Pett, Sarah, Phillips, Andrew N., Polizzotto, Mark N., Reilly, Cavan, Sandkovsky, Uriel, Sharma, Shweta, Teitelbaum, Marc, Thompson, B. Taylor, Young, Barnaby E., Neaton, James D., Lundgren, Jens D.“…Mechanisms to facilitate improved communication and harmonization among country-specific regulatory bodies are required.…”
Publicado 2021
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4354por Egnell, Manon, Talati, Zenobia, Galan, Pilar, Andreeva, Valentina A., Vandevijvere, Stefanie, Gombaud, Marion, Dréano-Trécant, Louise, Hercberg, Serge, Pettigrew, Simone, Julia, Chantal“…INTERPRETATION: In the context of FoPL harmonization in Europe, these findings from an online experiment provide insights into the Nutri-Score’s effectiveness on European consumers. …”
Publicado 2020
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4355por Koduah, Augustina, Kretchy, Irene, Sekyi-Brown, Reginald, Asiedu-Danso, Michelle, Ohene-Agyei, Thelma, Duwiejua, Mahama“…Important factors influencing the reforms included, health systems demands for village dispensaries and clinically oriented pharmacists, and harmonization with regional and international training and practice. …”
Publicado 2020
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4356por Teuho, Jarmo, Riehakainen, Leon, Honkaniemi, Aake, Moisio, Olli, Han, Chunlei, Tirri, Marko, Liu, Shihao, Grönroos, Tove J., Liu, Jie, Wan, Lin, Liang, Xiao, Ling, Yiqing, Hua, Yuexuan, Roivainen, Anne, Knuuti, Juhani, Xie, Qingguo, Teräs, Mika, D’Ascenzo, Nicola, Klén, Riku“…Further investigation should be performed to find an appropriate calibration and harmonization protocol and the evaluation should be conducted on a multi-scanner and multi-center level.…”
Publicado 2020
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4357por von der Lippe, Elena, Devleesschauwer, Brecht, Gourley, Michelle, Haagsma, Juanita, Hilderink, Henk, Porst, Michael, Wengler, Annelene, Wyper, Grant, Grant, Ian“…CONCLUSIONS: With the increase in national BoD studies developing their own strategies in data usage and implementation of statistical methods in the production of BoD estimates, there is a pressing need for equitable capacity building on the one hand, and harmonization of methods on the other hand. In response to these issues, several BoD networks have emerged in the European region that bring together expertise across different domains and professional backgrounds. …”
Publicado 2020
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4358por Stone, William, Nunes, Abraham, Akiyama, Kazufumi, Akula, Nirmala, Ardau, Raffaella, Aubry, Jean-Michel, Backlund, Lena, Bauer, Michael, Bellivier, Frank, Cervantes, Pablo, Chen, Hsi-Chung, Chillotti, Caterina, Cruceanu, Cristiana, Dayer, Alexandre, Degenhardt, Franziska, Del Zompo, Maria, Forstner, Andreas J., Frye, Mark, Fullerton, Janice M., Grigoroiu-Serbanescu, Maria, Grof, Paul, Hashimoto, Ryota, Hou, Liping, Jiménez, Esther, Kato, Tadafumi, Kelsoe, John, Kittel-Schneider, Sarah, Kuo, Po-Hsiu, Kusumi, Ichiro, Lavebratt, Catharina, Manchia, Mirko, Martinsson, Lina, Mattheisen, Manuel, McMahon, Francis J., Millischer, Vincent, Mitchell, Philip B., Nöthen, Markus M., O’Donovan, Claire, Ozaki, Norio, Pisanu, Claudia, Reif, Andreas, Rietschel, Marcella, Rouleau, Guy, Rybakowski, Janusz, Schalling, Martin, Schofield, Peter R., Schulze, Thomas G., Severino, Giovanni, Squassina, Alessio, Veeh, Julia, Vieta, Eduard, Trappenberg, Thomas, Alda, Martin“…Classification performance could potentially be improved by further harmonization of data collection procedures.…”
Publicado 2021
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4359“…Enabling data to be findable, accessible, interoperable, and reusable is currently believed to strengthen data sharing, reduce duplicated efforts, and move toward harmonization of data from heterogeneous unconnected data silos. …”
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4360por Vargas, Hugo M., Rolf, Michael G., Wisialowski, Todd A., Achanzar, William, Bahinski, Anthony, Bass, Alan, Benson, Charles T, Chaudhary, Khuram W., Couvreur, Nicolas, Dota, Corina, Engwall, Michael J, Michael Foley, C., Gallacher, David, Greiter‐Wilke, Andrea, Guillon, Jean‐Michel, Guth, Brian, Himmel, Herbert M., Hegele‐Hartung, Christa, Ito, Maki, Jenkinson, Stephen, Chiba, Katsuyoshi, Lagrutta, Armando, Levesque, Paul, Martel, Eric, Okai, Yoshiko, Peri, Ravikumar, Pointon, Amy, Qu, Yusheng, Teisman, Ard, Traebert, Martin, Yoshinaga, Takashi, Gintant, Gary A., Leishman, Derek J., Valentin, Jean‐Pierre“…In use for over 15 years, the nonclinical International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) S7B and clinical ICH E14 guidances describe three core assays (S7B: in vitro hERG current & in vivo QTc studies; E14: thorough QT study) that are used to assess the potential of drugs to cause delayed ventricular repolarization. …”
Publicado 2020
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