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Prof. Dr. med. MPH Lars G. Hemkens

Department of Clinical Research
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Publications

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Boesen, K., Hemkens, L. G., Janiaud, P., & Hirt, J. (2024). Publicly available continuously updated topic specific databases of randomised clinical trials: A scoping review [Posted-content]. Cold Spring Harbor Laboratory. https://doi.org/10.1101/2024.11.18.24317477

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Woelfle, Tim, Hirt, Julian, Janiaud, Perrine, Kappos, Ludwig, Ioannidis, John P.A., & Hemkens, Lars G. (2024). Benchmarking Human–AI collaboration for common evidence appraisal tools. Journal of Clinical Epidemiology, 175. https://doi.org/10.1016/j.jclinepi.2024.111533

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Elgersma, I. H., Elstroem, P., Hemkens, L. G., Helleve, A., Kacelnik, O., & Fretheim, A. (2024). Effect of Wearing Glasses for Prevention of SARS-CoV-2 on Visits to Health Care Providers - Additional Results from a Randomized Controlled Trial [Posted-content]. Cold Spring Harbor Laboratory. https://doi.org/10.1101/2024.08.29.24311868

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Pittelkow, M.-M., Linde, M., Anna de Vries, Y., Hemkens, L. G., Schmitt, A. M., Meijer, R. R., & van Ravenzwaaij, D. (2024). Strength of Statistical Evidence for the Efficacy of Cancer Drugs: A Bayesian Re-Analysis of Randomized Trials Supporting FDA Approval [Journal-article]. Journal of Clinical Epidemiology, 111479. https://doi.org/10.1016/j.jclinepi.2024.111479

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Woelfle, Tim, Hirt, Julian, Janiaud, Perrine, Kappos, Ludwig, Ioannidis, John P. A., & Hemkens, Lars G. (2024). Benchmarking Human-AI Collaboration for Common Evidence Appraisal Tools [Posted-content]. In medRxiv. Cold Spring Harbor Laboratory. https://doi.org/10.1101/2024.04.21.24306137

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Janiaud, Perrine, Zecca, Chiara, Salmen, Anke, Benkert, Pascal, Schädelin, Sabine, Orleth, Annette, Demuth, Lilian, Maceski, Aleksandra Maleska, Granziera, Cristina, Oechtering, Johanna, Leppert, David, Derfuss, Tobias, Achtnichts, Lutz, Findling, Oliver, Roth, Patrick, Lalive, Patrice, Uginet, Marjolaine, Müller, Stefanie, Pot, Caroline, et al. (2024). MultiSCRIPT-Cycle 1- A Pragmatic trial embedded within the Swiss Multiple Sclerosis Cohort (SMSC) on neurofilament light chain monitoring to inform personalized treatment decisions in Multiple Sclerosis: a study protocol for a randomized clinical trial [Posted-content]. In medRxiv. Cold Spring Harbor Laboratory. https://doi.org/10.1101/2024.03.22.24304720

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Nickolls, B. J., Relton, C., Hemkens, L., Zwarenstein, M., Eldridge, S., McCall, S. J., Griffin, X. L., Sohanpal, R., Verkooijen, H. M., Maguire, J. L., & McCord, K. A. (2024). Randomised trials conducted using cohorts: a scoping review. BMJ Open, 14(3). https://doi.org/10.1136/bmjopen-2023-075601

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Alonso, Ana Karen Macias, Hirt, Julian, Woelfle, Tim, Janiaud, Perrine, & Hemkens, Lars G. (2024). Definitions of digital biomarkers: a systematic mapping of the biomedical literature. BMJ Health and Care Informatics, 31. https://doi.org/10.1136/bmjhci-2023-100914

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Amstutz, Alain, Schönenberger, Christof M., Speich, Benjamin, Griessbach, Alexandra, Schwenke, Johannes M., Glasstetter, Jan, James, Sophie, Verkooijen, Helena M., Nickolls, Beverley, Relton, Clare, Hemkens, Lars G., Chammartin, Frédérique, Gerber, Felix, Labhardt, Niklaus D., Schandelmaier, Stefan, & Briel, Matthias. (2024). Characteristics, consent patterns, and challenges of randomized trials using the Trials within Cohorts (TwiCs) design - A scoping review. Journal of Clinical Epidemiology, 174. https://doi.org/10.1016/j.jclinepi.2024.111469

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Axfors, Cathrine, Schmitt, Andreas M., Janiaud, Perrine, van’t Hooft, Janneke, Abd-Elsalam, Sherief, Abdo, Ehab F., Abella, Benjamin S., Akram, Javed, Amaravadi, Ravi K., Angus, Derek C., Arabi, Yaseen M., Azhar, Shehnoor, Baden, Lindsey R., Baker, Arthur W., Belkhir, Leila, Benfield, Thomas, Berrevoets, Marvin A. H., Chen, Cheng-Pin, Chen, Tsung-Chia, et al. (2024). Author Correction: Mortality outcomes with hydroxychloroquine and chloroquine in COVID-19 from an international collaborative meta-analysis of randomized trials(Nature Communications, (2021), 12, (1), 10.1038/s41467-021-22446-z). Nature Communications, 15. https://doi.org/10.1038/s41467-024-45360-6

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Benkert, Pascal, Maleska Maceski, Aleksandra, Schaedelin, Sabine, Oechtering, Johanna, Zadic, Amar, Vilchez Gomez, Juan Francisco, Melie-Garcia, Lester, Cagol, Alessandro, Galbusera, Riccardo, Subramaniam, Suvitha, Lorscheider, Johannes, Galli, Edoardo, Mueller, Jannis, Fischer-Barnicol, Bettina, Achtnichts, Lutz, Findling, Oliver, Lalive, Patrice H., Bridel, Claire, Uginet, Marjolaine, et al. (2024). Serum Glial Fibrillary Acidic Protein and Neurofilament Light Chain Levels Reflect Different Mechanisms of Disease Progression under B-Cell Depleting Treatment in Multiple Sclerosis. Annals of Neurology. https://doi.org/10.1002/ana.27096

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Djulbegovic, Benjamin, Hozo, Iztok, Koletsi, Despina, Price, Amy, Nunan, David, & Hemkens, Lars G. (2024). What is the probability that higher versus lower quality of evidence represents true effects estimates? Journal of Evaluation in Clinical Practice. https://doi.org/10.1111/jep.14160

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Djulbegovic, Benjamin, Koletsi, Despina, Hozo, Iztok, Price, Amy, Martimbianco, Ana Luiza Cabrera, Riera, Rachel, Nadanovsky, Paulo, dos Santos, Ana Paula Pires, Pandis, Nikolaos, Pacheco, Rafael Leite, Fontes, Luis Eduardo, Seehra, Jadbinder, Ahmed, Muneeb, Yao, Liang, Nunan, David, & Hemkens, Lars G. (2024). High certainty evidence is stable and trustworthy, whereas evidence of moderate or lower certainty may be equally prone to being unstable. Journal of Clinical Epidemiology, 171. https://doi.org/10.1016/j.jclinepi.2024.111392

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Fretheim, Atle, Solberg, Runar Barstad, & Hemkens, Lars G. (2024). The polarised discourse around face masks is hindering constructive debate. Bmj. https://doi.org/10.1136/bmj.q1661

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Griessbach, Alexandra, Speich, Benjamin, Amstutz, Alain, Hausheer, Lena, Covino, Manuela, Wnfried Ramirez, Hillary, Schandelmaier, Stefan, Taji Heravi, Ala, Treweek, Shaun, Schwenkglenks, Matthias, Briel, Matthias, von Niederhäusern, Belinda, Hemkens, Lars G., Kasenda, Benjamin, Pauli-Magnus, Christiane, & McLennan, Stuart. (2024). Resource use and costs of investigator-sponsored randomized clinical trials in Switzerland, Germany, and the United Kingdom: a metaresearch study. Journal of Clinical Epidemiology, 176. https://doi.org/10.1016/j.jclinepi.2024.111536

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Hirt, Julian, Dembowska, Kinga, Woelfle, Tim, Axfors, Cathrine, Granziera, Cristina, Kuhle, Jens, Kappos, Ludwig, Hemkens, Lars G., & Janiaud, Perrine. (2024). Clinical trial evidence of quality-of-life effects of disease-modifying therapies for multiple sclerosis: a systematic analysis. Journal of Neurology. https://doi.org/10.1007/s00415-024-12366-5

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Hirt, Julian, Janiaud, Perrine, Düblin, Pascal, Nicoletti, Giovanni Jacopo, Dembowska, Kinga, Nguyen, Thao Vy Thi, Woelfle, Tim, Axfors, Cathrine, Yaldizli, Özgür, Granziera, Cristina, Kuhle, Jens, Kappos, Ludwig, & Hemkens, Lars G. (2024). Use of pragmatic randomized trials in multiple sclerosis: A systematic overview. Multiple Sclerosis Journal, 30, 463–478. https://doi.org/10.1177/13524585231221938

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Janiaud, Perrine, Zecca, Chiara, Salmen, Anke, Benkert, Pascal, Schädelin, Sabine, Orleth, Annette, Demuth, Lilian, Maceski, Aleksandra Maleska, Granziera, Cristina, Oechtering, Johanna, Leppert, David, Derfuss, Tobias, Achtnichts, Lutz, Findling, Oliver, Roth, Patrick, Lalive, Patrice, Uginet, Marjolaine, Müller, Stefanie, Pot, Caroline, et al. (2024). MultiSCRIPT-Cycle 1—a pragmatic trial embedded within the Swiss Multiple Sclerosis Cohort (SMSC) on neurofilament light chain monitoring to inform personalized treatment decisions in multiple sclerosis: a study protocol for a randomized clinical trial. Trials, 25. https://doi.org/10.1186/s13063-024-08454-6

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Kepp, Kasper P., Aavitsland, Preben, Ballin, Marcel, Balloux, Francois, Baral, Stefan, Bardosh, Kevin, Bauchner, Howard, Bendavid, Eran, Bhopal, Raj, Blumstein, Daniel T., Boffetta, Paolo, Bourgeois, Florence, Brufsky, Adam, Collignon, Peter J., Cripps, Sally, Cristea, Ioana A., Curtis, Nigel, Djulbegovic, Benjamin, Faude, Oliver, et al. (2024). Panel stacking is a threat to consensus statement validity. Journal of Clinical Epidemiology, 173. https://doi.org/10.1016/j.jclinepi.2024.111428

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Lüthi, Hualin, Lengsfeld, Sophia, Burkard, Thilo, Meienberg, Andrea, Jeanloz, Nica, Vukajlovic, Tanja, Bologna, Katja, Steinmetz, Michelle, Bathelt, Cemile, Sailer, Clara O., Laager, Mirjam, Vogt, Deborah R., Hemkens, Lars G., Speich, Benjamin, Urwyler, Sandrine A., Kühne, Jill, Baur, Fabienne, Lutz, Linda N., Erlanger, Tobias E., et al. (2024). Effect of dulaglutide in promoting abstinence during smoking cessation: 12-month follow-up of a single-centre, randomised, double-blind, placebo-controlled, parallel group trial. eClinicalMedicine, 68. https://doi.org/10.1016/j.eclinm.2024.102429

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Puljak, Livia, Bala, Małgorzata M., Zając, Joanna, Meštrović, Tomislav, Buttigieg, Sandra, Yanakoulia, Mary, Briel, Matthias, Lunny, Carole, Lesniak, Wiktoria, Poklepović Peričić, Tina, Alonso-Coello, Pablo, Clarke, Mike, Djulbegovic, Benjamin, Gartlehner, Gerald, Giannakou, Konstantinos, Glenny, Anne-Marie, Glenton, Claire, Guyatt, Gordon, Hemkens, Lars G., et al. (2024). Methods proposed for monitoring the implementation of evidence-based research: a cross-sectional study [Journal-article]. Journal of Clinical Epidemiology, 168, 111247. https://doi.org/10.1016/j.jclinepi.2024.111247

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Solberg, Runar Barstad, Fretheim, Atle, Elgersma, Ingeborg Hess, Fagernes, Mette, Iversen, Bjørn Gunnar, Hemkens, Lars G., Rose, Christopher James, & Elstrøm, Petter. (2024). Personal protective effect of wearing surgical face masks in public spaces on self-reported respiratory symptoms in adults: pragmatic randomised superiority trial. Bmj. https://doi.org/10.1136/bmj-2023-078918

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Wei, Lili, Kuenzig, Ellen, Im, James, Zheng, Yan, McLinden, Taylor, Emerson, Scott, Eissa, Azza, Halder, Henry, Shaw, Richard, Chan, An-Wen, Dixon, William, Ehrenstein, Vera, Guttmann, Astrid, Harron, Katie, Hemkens, Lars G., Hróbjartsson, Asbjørn, Lyons, Ronan, MacDonald, Shannon E., Maniate, Jerry, et al. (2024). Methodological Challenges when Using Routinely Collected Health Data for Research: A scoping review. 9. https://doi.org/10.23889/ijpds.v9i5.2610

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Zietz, Annaelle, Kaufmann, Josefin E, Wiesner, Karin, Fischer, Sandro Kevin, Wiegert, Martina, Verhagen-Kamerbeek, Wilma DJ, Rottenberger, Yannik, Schwarz, Anne, Peters, Nils, Gensicke, Henrik, Medlin, Friedrich, Möller, Jens Carsten, Bujan, Bartosz, Bonati, Leo H, Arnold, Marcel, Schaedelin, Sabine, Müri, René M., Hemkens, Lars G, Michel, Patrik, et al. (2024). Enhancement of STroke REhabilitation with Levodopa (ESTREL): Rationale and design of a randomized placebo-controlled, double blind superiority trial. European Stroke Journal. https://doi.org/10.1177/23969873241255867

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Hirt, Julian, Janiaud, Perrine, Düblin, Pascal, & Hemkens, Lars G. (2023). Meta-research on pragmatism of randomized trials: rationale and design of the PragMeta database. Trials, 24(1). https://doi.org/10.1186/s13063-023-07474-y

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Lengsfeld, Sophia, Burkard, Thilo, Meienberg, Andrea, Jeanloz, Nica, Coynel, David, Vogt, Deborah R., Hemkens, Lars G., Speich, Benjamin, Zanchi, Davide, Erlanger, Tobias E., Christ-Crain, Mirjam, & Winzeler, Bettina. (2023). Glucagon-like peptide-1 analogues: a new way to quit smoking? (SKIP)—a structured summary of a study protocol for a randomized controlled study. Trials, 24(1). https://doi.org/10.1186/s13063-023-07164-9

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Holst, M., Haslberger, M., Yerunkar, S., Strech, D., Hemkens, L. G., & Carlisle, B. G. (2023). Frequency of multiple changes to prespecified primary outcomes of clinical trials completed between 2009 and 2017 in German university medical centers: A meta-research study. PLoS Medicine, 20(10 October). https://doi.org/10.1371/journal.pmed.1004306

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Alonso, A. K. M., Hirt, J., Woelfle, T., Janiaud, P., & Hemkens, L. G. (2023). Definitions of digital biomarkers: a systematic mapping of the biomedical literature [Posted-content]. Cold Spring Harbor Laboratory. https://doi.org/10.1101/2023.09.01.23294897

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Dal-Ré R, Banzi R, Cristea IA, Fernández-de-Las-Peñas C, Hemkens LG, Janiaud P, Jansen MS, Naudet F, & Rosendaal FR. (2023). Using the phases of clinical development of medicines to describe clinical trials assessing other interventions is widespread but not useful. Journal of Clinical Epidemiology, 161, 157–163. https://doi.org/10.1016/j.jclinepi.2023.07.011

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Goldkuhle, Marius, Hirsch, Caroline, Iannizzi, Claire, Bora, Ana-Mihaela, Bender, Ralf, van Dalen, Elvira C., Hemkens, Lars G., Trivella, Marialene, Monsef, Ina, Kreuzberger, Nina, & Skoetz, Nicole. (2023). Meta-epidemiological review identified variable reporting and handling of time-to-event analyses in publications of trials included in meta-analyses of systematic reviews. Journal of Clinical Epidemiology, 159, 174–189. https://doi.org/10.1016/j.jclinepi.2023.05.023

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Goldkuhle M, Guyatt GH, Kreuzberger N, Akl EA, Dahm P, van Dalen EC, Hemkens LG, Klugar M, Mustafa RA, Nonino F, Schünemann HJ, Trivella M, & Skoetz N. (2023). GRADE concept 4: rating the certainty of evidence when study interventions or comparators differ from PICO targets. Journal of Clinical Epidemiology, 159, 40–48. https://doi.org/10.1016/j.jclinepi.2023.04.018

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Pittelkow, M.-M., Linde, M., de Vries, Y. A., Hemkens, L. G., Schmitt, A. M., Meijer, R. R., & van Ravenzwaaij, D. (2023, June 30). Strength of Statistical Evidence for the Efficacy of Cancer Drugs: A Bayesian Re-Analysis of Trials Supporting FDA Approval [Posted-content]. Cold Spring Harbor Laboratory. https://doi.org/10.1101/2023.06.30.23292074

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Meyer, M., Appenzeller-Herzog, C., Cattaneo, M., & Hemkens, L. G. (2023, March 7). Adverse effects of opioids prescribed in opioid agonist treatment: a systematic review protocol [Posted-content]. Center for Open Science. https://doi.org/10.31219/osf.io/h2nr6

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Lengsfeld, Sophia, Burkard, Thilo, Meienberg, Andrea, Jeanloz, Nica, Vukajlovic, Tanja, Bologna, Katja, Steinmetz, Michelle, Bathelt, Cemile, Sailer, Clara O., Vogt, Deborah R., Hemkens, Lars G., Speich, Benjamin, Urwyler, Sandrine A., Kühne, Jill, Baur, Fabienne, Lutz, Linda N., Erlanger, Tobias E., Christ-Crain, Mirjam, & Winzeler, Bettina. (2023). Effect of dulaglutide in promoting abstinence during smoking cessation: a single-centre, randomized, double-blind, placebo-controlled, parallel group trial. eClinicalMedicine, 57. https://doi.org/10.1016/j.eclinm.2023.101865

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Cobey KD, Haustein S, Brehaut J, Dirnagl U, Franzen DL, Hemkens LG, Presseau J, Riedel N, Strech D, Alperin JP, Costas R, Sena ES, van Leeuwen T, Ardern CL, Bacellar IOL, Camack N, Britto Correa M, Buccione R, Cenci MS, et al. (2023). Community consensus on core open science practices to monitor in biomedicine. PLoS Biology, 21(1), e3001949. https://doi.org/10.1371/journal.pbio.3001949

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Ebrahimi, Fahim, Hirt, Julian, Schönenberger, Christof, Ewald, Hannah, Briel, Matthias, Janiaud, Perrine, & Hemkens, Lars G. (2023). Colchicine for the secondary prevention of cardiovascular events. Cochrane Database of Systematic Reviews, 2023(8). https://doi.org/10.1002/14651858.cd014808

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Gloy, Viktoria, Schmitt, Andreas M., Düblin, Pascal, Hirt, Julian, Axfors, Cathrin, Kuk, Hanna, Pereira, Tiago V., Locher, Clara, Caquelin, Laura, Walter-Claudi, Martin, Lythgoe, Mark P., Herbrand, Amanda, Kasenda, Benjamin, & Hemkens, Lars G. (2023). The evidence base of US Food and Drug Administration approvals of novel cancer therapies from 2000 to 2020. International Journal of Cancer, 152, 2474–2484. https://doi.org/10.1002/ijc.34473

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Hirt, Julian, Janiaud, Perrine, Gloy, Viktoria Luise, Schandelmaier, Stefan, Pereira, Tiago V., Contopoulos-Ioannidis, Despina, Goodman, Steven N., Ioannidis, John, Munkholm, Klaus, & Hemkens, Lars G. (2023). Robustness of reported postacute health outcomes in children with SARS-CoV-2 infection: A systematic review. Archives of Disease in Childhood, 108, 498–505. https://doi.org/10.1136/archdischild-2022-324455

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Fretheim A, Elgersma IH, Helleve A, Elstrøm P, Kacelnik O, & Hemkens LG. (2022). Effect of Wearing Glasses on Risk of Infection with SARS-CoV-2 in the Community: A Randomized Clinical Trial. JAMA Network Open, 5(12), e2244495. https://doi.org/10.1001/jamanetworkopen.2022.44495

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Hirt J, Janiaud P, & Hemkens LG. (2022). Clinical trial research agenda on COVID-19 - the first two years in Germany and beyond. Zeitschrift Fur Evidenz, Fortbildung Und Qualitat Im Gesundheitswesen, 174, 32–42. https://doi.org/10.1016/j.zefq.2022.08.003

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Atila C, Loughrey PB, Garrahy A, Winzeler B, Refardt J, Gildroy P, Hamza M., Pal A, Verbalis JG, Thompson CJ, Hemkens L.G., Hunter SJ, Sherlock M, Levy MJ, Karavitaki N., Newell-Price J, Wass JAH, & Christ-Crain M. (2022). Central diabetes insipidus from a patient’s perspective: management, psychological co-morbidities, and renaming of the condition: results from an international web-based survey. The Lancet Diabetes and Endocrinology, 10(10), 700–709. https://doi.org/10.1016/s2213-8587(22)00219-4

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Ewald H, Klerings I, Wagner G, Heise TL, Stratil JM, Lhachimi SK, Hemkens LG, Gartlehner G, Armijo-Olivo S, & Nussbaumer-Streit B. (2022). Searching two or more databases decreased the risk of missing relevant studies: a metaresearch study. Journal of Clinical Epidemiology, 149, 154–164. https://doi.org/10.1016/j.jclinepi.2022.05.022

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Hirt J, Ewald H, Lawson DO, Hemkens LG, Briel M, & Schandelmaier S. (2022). A systematic survey of methods guidance suggests areas for improvement regarding access, development, and transparency. Journal of Clinical Epidemiology, 149, 217–226. https://doi.org/10.1016/j.jclinepi.2022.05.005

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Fretheim, A., Elgersma, I. H., Helleve, A., Elstrøm, P., Kacelnik, O., & Hemkens, L. G. (2022). Glasses Against transmission of SARS-CoV-2 in the community (GLASSY): a pragmatic randomized trial [Posted-content]. Cold Spring Harbor Laboratory. https://doi.org/10.1101/2022.07.31.22278223

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Hemmig AK, Gozzoli D, Werlen L, Ewald H, Aschwanden M, Blockmans D, Brouwer E, Buchanan RRC, Camellino D, Campochiaro C, Cimmino MA, Corominas H, Gloy V, Henckaerts L, Kyburz D, Moya-Alvarado P, Owen CE, Stegert M, Tomelleri A, et al. (2022). Subclinical giant cell arteritis in new onset polymyalgia rheumatica A systematic review and meta-analysis of individual patient data. Seminars in Arthritis and Rheumatism, 55, 152017. https://doi.org/10.1016/j.semarthrit.2022.152017

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Cobey, K. D., Haustein, S., Brehaut, J., Dirnagl, U., Franzen, D. L., Hemkens, L. G., Presseau, J., Riedel, N., Strech, D., Alperin, J. P., Costas, R., Sena, E. S., van Leeuwen, T., Ardern, C. L., Bacellar, I. O. L., Camack, N., Correa, M. B., Buccione, R., Cenci, M. S., et al. (2022). Establishing a core set of open science practices in biomedicine: a modified Delphi study [Posted-content]. Cold Spring Harbor Laboratory. https://doi.org/10.1101/2022.06.27.22276964

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Djulbegovic B, Ahmed MM, Hozo I, Koletsi D, Hemkens L, Price A, Riera R, Nadanovsky P, Dos Santos APP, Melo D, Pathak R, Pacheco RL, Fontes LE, Miranda E, & Nunan D. (2022). High quality (certainty) evidence changes less often than low-quality evidence, but the magnitude of effect size does not systematically differ between studies with low versus high-quality evidence. Journal of Evaluation in Clinical Practice, 28(3), 353–362. https://doi.org/10.1111/jep.13657

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Schmitt AM, Walter M, Herbrand AK, Jörger M, Moffa G, Novak U, Hemkens L, & Kasenda B. (2022). Characteristics and survival of patients with cancer with intended off-label use - A cohort study. BMJ Open, 12(5), e060453. https://doi.org/10.1136/bmjopen-2021-060453

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Hirt, J., Janiaud, P., Gloy, V., Schandelmaier, S., Pereira, T. V., Contopoulos-Ioannidis, D. G., Goodman, S. N., Ioannidis, J. P. A., Munkholm, K., & Hemkens, L. G. (2022). Validity of reported post-acute health outcomes in children with SARS-CoV-2 infection: a systematic review [Posted-content]. Cold Spring Harbor Laboratory. https://doi.org/10.1101/2022.03.18.22272582

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De Marchis GM, Wright PR, Michel P, Strambo D, Carrera E, Dirren E, Luft AR, Wegener S, Cereda CW, Kägi G, Vehoff J, Gensicke H, Lyrer P, Nedeltchev K, Khales T, Bolognese M, Salmen S, Sturzenegger R, Bonvin C, et al. (2022). Association of the COVID-19 outbreak with acute stroke care in Switzerland. European Journal of Neurology, 29(3), 724–731. https://doi.org/10.1111/ene.15209

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Ewald, Hannah, Klerings, Irma, Wagner, Gernot, Heise, Thomas L, Stratil, Jan M, Lhachimi, Stefan K, Hemkens, Lars G, Gartlehner, Gerald, Armijo-Olivo, Susan, & Nussbaumer-Streit, Barbara. (2022). Searching two or more databases decreased the risk of missing relevant studies: a metaresearch study. Journal of Clinical Epidemiology, 149, 154–164. https://doi.org/10.1016/j.jclinepi.2022.05.022

Gryaznov, D., von Niederhäusern, B., Speich, B., Kasenda, B., Ojeda-Ruiz, E., Blümle, A., Schandelmaier, S., Mertz, D., Odutayo, A., Tomonaga, Y., Amstutz, A., Pauli-Magnus, C., Gloy, V., Lohner, S., Bischoff, K., Wollmann, K., Rehner, L., Meerpohl, J. J., Nordmann, A., et al. (2022). Reporting quality of clinical trial protocols: a repeated cross-sectional study about the Adherence to SPIrit recommendations in Switzerland, CAnada and GErmany (ASPIRE-SCAGE). BMJ Open, 12(5), e053417. https://doi.org/10.1136/bmjopen-2021-053417

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Hemkens LG, Juszczak E, & Thombs BD. (2022). Reporting transparency and completeness in trials: Paper 1: Introduction - Better reporting for disruptive clinical trials using routinely collected data. 141, 172–174. https://doi.org/10.1016/j.jclinepi.2021.09.017

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Hirt J, Janiaud P, & Hemkens LG. (2022). Randomized trials on non-pharmaceutical interventions for COVID-19: a scoping review. BMJ Evidence-Based Medicine, 27(6), 334–344. https://doi.org/10.1136/bmjebm-2021-111825

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Imran M, Mc Cord K, McCall SJ, Kwakkenbos L, Sampson M, Fröbert O, Gale C, Hemkens LG, Langan SM, Moher D, Relton C, Zwarenstein M, Juszczak E, Thombs BD, & CONSORT Extension for Trials Conducted Using Cohorts and Routinely Collected Data Group. (2022). Reporting transparency and completeness in trials: Paper 3 – trials conducted using administrative databases do not adequately report elements related to use of databases. Journal of Clinical Epidemiology, 141, 187–197. https://doi.org/10.1016/j.jclinepi.2021.09.010

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McCall SJ, Imran M, Hemkens LG, Mc Cord K, Kwakkenbos L, Sampson M, Jawad S, Zwarenstein M, Relton C, Langan SM, Moher D, Fröbert O, Thombs BD, Gale C, Juszczak E, & CONSORT Extension for Trials Conducted Using Cohorts and RoutinelyCollected Data Group. (2022). Reporting transparency and completeness in trials: Paper 4 - reporting of randomised controlled trials conducted using routinely collected electronic records – room for improvement. Journal of Clinical Epidemiology, 141, 198–209. https://doi.org/10.1016/j.jclinepi.2021.09.011

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Mc Cord KA, Imran M, Rice DB, McCall SJ, Kwakkenbos L, Sampson M, Fröbert O, Gale C, Langan SM, Moher D, Relton C, Zwarenstein M, Juszczak E, Thombs BD, Hemkens LG, & CONSORT Extension for Trials Conducted Using Cohorts and Routinely Collected Data Group. (2022). Reporting transparency and completeness in Trials: Paper 2 - reporting of randomised trials using registries was often inadequate and hindered the interpretation of results. Journal of Clinical Epidemiology, 141, 175–186. https://doi.org/10.1016/j.jclinepi.2021.09.012

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Schwab, Simon, Janiaud, Perrine, Dayan, Michael, Amrhein, Valentin, Panczak, Radoslaw, Palagi, Patricia M., Hemkens, Lars G., Ramon, Meike, Rothen, Nicolas, Senn, Stephen, Furrer, Eva, & Held, Leonhard. (2022). Ten simple rules for good research practice. PLoS Computational Biology, 18(6), e1010139. https://doi.org/10.1371/journal.pcbi.1010139

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Speich, B., Gryaznov, D., Busse, J. W., Gloy, V. L., Lohner, S., Klatte, K., Taji Heravi, A., Ghosh, N., Lee, H., Mansouri, A., Marian, I. R., Saccilotto, R., Nury, E., Kasenda, B., Ojeda-Ruiz, E., Schandelmaier, S., Tomonaga, Y., Amstutz, A., Pauli-Magnus, C., et al. (2022). Nonregistration, discontinuation, and nonpublication of randomized trials: a repeated metaresearch analysis. PLoS Med, 19(4), e1003980. https://doi.org/10.1371/journal.pmed.1003980

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Axfors C, Janiaud P, Schmitt AM, Van’t Hooft J, Smith ER, Haber NA, Abayomi A, Abduljalil M, Abdulrahman A, Acosta-Ampudia Y, Aguilar-Guisado M, Al-Beidh F, Alejandria MM, Alfonso RN, Ali M, AlQahtani M, AlZamrooni A, Anaya JM, Ang MAC, et al. (2021). Association between convalescent plasma treatment and mortality in COVID-19: a collaborative systematic review and meta-analysis of randomized clinical trials. BMC Infectious Diseases, 21(1), 1170. https://doi.org/10.1186/s12879-021-06829-7

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Axfors C, Schmitt AM, Janiaud P, Van’t Hooft J, Abd-Elsalam S, Abdo EF, Abella BS, Akram J, Amaravadi RK, Angus DC, Arabi YM, Azhar S, Baden LR, Baker AW, Belkhir L, Benfield T, Berrevoets MAH, Chen CP, Chen TC, et al. (2021). Author Correction: Mortality outcomes with hydroxychloroquine and chloroquine in COVID-19 from an international collaborative meta-analysis of randomized trials (Nature Communications, (2021), 12, 1, (2349), 10.1038/s41467-021-22446-z) (Patent No. 1). 12(1), Article 1. https://doi.org/10.1038/s41467-021-23559-1

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Axfors C, Schmitt AM, Janiaud P, Van’t Hooft J, Abd-Elsalam S, Abdo EF, Abella BS, Akram J, Amaravadi RK, Angus DC, Arabi YM, Azhar S, Baden LR, Baker AW, Belkhir L, Benfield T, Berrevoets MAH, Chen CP, Chen TC, et al. (2021). Mortality outcomes with hydroxychloroquine and chloroquine in COVID-19 from an international collaborative meta-analysis of randomized trials. Nature Communications, 12(1), 2349. https://doi.org/10.1038/s41467-021-22446-z

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Speich B, Chammartin F, Smith D, Stoeckle MP, Amico P, Eichenberger AL, Hasse B, Schuurmans MM, Müller T, Tamm M, Dickenmann M, Abela IA, Trkola A, Hirsch HH, Manuel O, Cavassini M, Hemkens LG, Briel M, Mueller NJ, et al. (2021). A trial platform to assess approved SARS-CoV-2 vaccines in immunocompromised patients: first sub-protocol for a pilot trial comparing the mRNA vaccines Comirnaty® and COVID-19 mRNA Vaccine Moderna®. Trials, 22(1), 724. https://doi.org/10.1186/s13063-021-05664-0

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McLennan, Stuart, Nussbaumer-Streit, Barbara, Hemkens, Lars G., & Briel, Matthias. (2021). Barriers and Facilitating Factors for Conducting Systematic Evidence Assessments in Academic Clinical Trials. JAMA Network Open, 4(11), E2136577. https://doi.org/10.1001/jamanetworkopen.2021.36577

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Schwab, S., Janiaud, P., Dayan, M., Amrhein, V., Panczak, R., Palagi, P. M., Hemkens, L. G., Ramon, M., Rothen, N., Senn, S., Furrer, E., & Held, L. (2021). Ten simple rules for good research practice [Posted-content]. Center for Open Science. https://doi.org/10.31219/osf.io/am5ck

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Taji Heravi A, Gryaznov D, Schandelmaier S, Kasenda B, Briel M, & Adherence to SPIRIT Recommendations (ASPIRE) Study Group. (2021). Evaluation of Planned Subgroup Analysis in Protocols of Randomized Clinical Trials. JAMA Network Open, 4(10), e2131503. https://doi.org/10.1001/jamanetworkopen.2021.31503

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Hemkens LG. (2021). [Benefit assessment of digital health applications-challenges and opportunities]. Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz, 64(10), 1269–1277. https://doi.org/10.1007/s00103-021-03413-x

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Hemkens LG, & Goodman SN. (2021). Randomized COVID-19 vaccination rollout can offer direct real-world evidence. Journal of Clinical Epidemiology, 138, 199–202. https://doi.org/10.1016/j.jclinepi.2021.05.014

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Kappos EA, Schulz A, Regan MM, Moffa G, Harder Y, Ribi K, Potter S, Pusic AL, Fehr MK, Hemkens LG, Holzbach T, Farhadi J, Simonson C, Knauer M, Verstappen R, Bucher HC, Zwahlen D, Zimmermann F, Schwenkglenks M, et al. (2021). Prepectoral versus subpectoral implant-based breast reconstruction after skin-sparing mastectomy or nipple-sparing mastectomy (OPBC-02/ PREPEC): A pragmatic, multicentre, randomised, superiority trial. BMJ Open, 11(9), e045239. https://doi.org/10.1136/bmjopen-2020-045239

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Janiaud P, Hemkens LG, & Ioannidis JPA. (2021). Challenges and Lessons Learned From COVID-19 Trials: Should We Be Doing Clinical Trials Differently? Canadian Journal of Cardiology, 37(9), 1353–1364. https://doi.org/10.1016/j.cjca.2021.05.009

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Hirt, J., Janiaud, P., & Hemkens, L. G. (2021). Randomized trials on non-pharmaceutical interventions for COVID-19 as of August 2021: a meta-epidemiological analysis [Posted-content]. Cold Spring Harbor Laboratory. https://doi.org/10.1101/2021.08.20.21261687

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Imran M, Kwakkenbos L, McCall SJ, McCord KA, Fröbert O, Hemkens LG, Zwarenstein M, Relton C, Rice DB, Langan SM, Benchimol EI, Thabane L, Campbell MK, Sampson M, Erlinge D, Verkooijen HM, Moher D, Boutron I, Ravaud P, et al. (2021). Methods and results used in the development of a consensus-driven extension to the Consolidated Standards of Reporting Trials (CONSORT) statement for trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE). BMJ Open, 11(4), e049093. https://doi.org/10.1136/bmjopen-2021-049093

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Kwakkenbos L, Imran M, McCall SJ, McCord KA, Fröbert O, Hemkens LG, Zwarenstein M, Relton C, Rice DB, Langan SM, Benchimol EI, Thabane L, Campbell MK, Sampson M, Erlinge D, Verkooijen HM, Moher D, Boutron I, Ravaud P, et al. (2021). CONSORT extension for the reporting of randomised controlled trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE): Checklist with explanation and elaboration. The BMJ, 373, n857. https://doi.org/10.1136/bmj.n857

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Janiaud P, Axfors C, Schmitt AM, Gloy V, Ebrahimi F, Hepprich M, Smith ER, Haber NA, Khanna N, Moher D, Goodman SN, Ioannidis JPA, & Hemkens LG. (2021). Association of Convalescent Plasma Treatment with Clinical Outcomes in Patients with COVID-19: A Systematic Review and Meta-analysis. JAMA - Journal of the American Medical Association, 325(12), 1185–1195. https://doi.org/10.1001/jama.2021.2747

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Janiaud P, Axfors C, Ioannidis JPA, & Hemkens LG. (2021). Recruitment and Results Reporting of COVID-19 Randomized Clinical Trials Registered in the First 100 Days of the Pandemic. JAMA Network Open, 4(3), e210330. https://doi.org/10.1001/jamanetworkopen.2021.0330

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Herbrand, Amanda Katherina, Schmitt, Andreas M., Briel, Matthias, Ewald, Hannah, Goldkuhle, Marius, Diem, Stefan, Hoogkamer, Anouk, Joerger, Markus, Moffa, Giusi, Novak, Urban, Hemkens, Lars G., & Kasenda, Benjamin. (2021). Association of Supporting Trial Evidence and Reimbursement for Off-Label Use of Cancer Drugs. Jama Network Open, 4(3), e210380. https://doi.org/10.1001/jamanetworkopen.2021.0380

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Hirt, Julian, Rasadurai, Abeelan, Briel, Matthias, Düblin, Pascal, Janiaud, Perrine, & Hemkens, Lars G. (2021). Clinical trial research on COVID-19 in Germany - a systematic analysis. F1000Research, 10, 913. https://doi.org/10.12688/f1000research.55541.1

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Lohner, Szimonetta, Gryaznov, Dmitry, von Niederhäusern, Belinda, Speich, Benjamin, Kasenda, Benjamin, Ojeda-Ruiz, Elena, Schandelmaier, Stefan, Mertz, Dominik, Odutayo, Ayodele, Tomonaga, Yuki, Amstutz, Alain, Pauli-Magnus, Christiane, Gloy, Viktoria, Bischoff, Karin, Wollmann, Katharina, Rehner, Laura, Meerpohl, Joerg J., Nordmann, Alain, Klatte, Katharina, et al. (2021). Reporting quality of trial protocols improved for non-regulated interventions but not regulated interventions: A repeated cross-sectional study. Journal of Clinical Epidemiology, 139, 340–349. https://doi.org/10.1016/j.jclinepi.2021.05.011

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McCarthy M, O’Keeffe L, Williamson PR, Sydes MR, Farrin A, Lugg-Widger F, Davies G, Avery K, Chan AW, Kwakkenbos L, Thombs BD, Watkins A, Hemkens LG, Gale C, Zwarenstein M, Langan SM, Thabane L, Juszczak E, Moher D, & Kearney PM. (2021). A study protocol for the development of a SPIRIT extension for trials conducted using cohorts and routinely collected data (SPIRIT-ROUTINE). HRB Open Research, 4, 82. https://doi.org/10.12688/hrbopenres.13314.1

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Mc Cord, Kimberly A., Ewald, Hannah, Agarwal, Arnav, Glinz, Dominik, Aghlmandi, Soheila, Ioannidis, John P. A., & Hemkens, Lars G. (2021). Treatment effects in randomised trials using routinely collected data for outcome assessment versus traditional trials: meta-research study. Bmj, 372, n450. https://doi.org/10.1136/bmj.n450

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Hepprich M, Donath MY, & Hemkens L.G. (2020). Patient involvement to inform the design of a clinical trial in postbariatric hypoglycaemia. BMC Medical Research Methodology, 20(1), 290. https://doi.org/10.1186/s12874-020-01171-z

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Merlo C, Essig S, Brancati-Badarau DO, Leuppi JD, Speich B, Erlanger TE, Hemkens L.G., & Zeller A. (2020). Oral corticosteroids for post-infectious cough in adults: study protocol for a double-blind randomized placebo-controlled trial in Swiss family practices (OSPIC trial). Trials, 21(1), 949. https://doi.org/10.1186/s13063-020-04848-4

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Hemkens L.G. (2020). Commentary on Bertagnolli et al: Clinical trial designs with routinely collected real-world data—issues of data quality and beyond. Clinical Trials, 17(3), 247–250. https://doi.org/10.1177/1740774520913845

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Munkholm K, Faurholt-Jepsen M, Ioannidis JPA, & Hemkens LG. (2020). Consideration of confounding was suboptimal in the reporting of observational studies in psychiatry: a meta-epidemiological study. Journal of Clinical Epidemiology, 119, 75–84. https://doi.org/10.1016/j.jclinepi.2019.12.002

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Kohavi R, Tang D, Xu Y, Hemkens LG, & Ioannidis JPA. (2020). Online randomized controlled experiments at scale: Lessons and extensions to medicine. Trials, 21(1), 150. https://doi.org/10.1186/s13063-020-4084-y

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Ewald, Hannah, Klerings, Irma, Wagner, Gernot, Heise, Thomas L., Dobrescu, Andreea Iulia, Armijo-Olivo, Susan, Stratil, Jan M., Lhachimi, Stefan K., Mittermayr, Tarquin, Gartlehner, Gerald, Nussbaumer-Streit, Barbara, & Hemkens, Lars G. (2020). Abbreviated and comprehensive literature searches led to identical or very similar effect estimates: meta-epidemiological study. Journal of Clinical Epidemiology, 128, 1–12. https://doi.org/10.1016/j.jclinepi.2020.08.002

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Gryaznov, D., Odutayo, A., von Niederhausern, B., Speich, B., Kasenda, B., Ojeda-Ruiz, E., Blumle, A., Schandelmaier, S., Mertz, D., Tomonaga, Y., Amstutz, A., Pauli-Magnus, C., Gloy, V., Bischoff, K., Wollmann, K., Rehner, L., Lohner, S., Meerpohl, J. J., Nordmann, A., et al. (2020). Rationale and design of repeated cross-sectional studies to evaluate the reporting quality of trial protocols: the Adherence to SPIrit REcommendations (ASPIRE) study and associated projects. Trials, 21(1), 896. https://doi.org/10.1186/s13063-020-04808-y

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Janiaud P, Axfors C, Van’t Hooft J, Saccilotto R, Agarwal A, Appenzeller-Herzog C, Contopoulos-Ioannidis DG, Danchev V, Dirnagl U, Ewald H, Gartlehner G, Goodman SN, Haber NA, Ioannidis AD, Ioannidis JPA, Lythgoe MP, Ma W, Macleod M, Malički M, et al. (2020). The worldwide clinical trial research response to the COVID-19 pandemic - the first 100 days. F1000Research, 9, 1193. https://doi.org/10.12688/f1000research.26707.1

Janiaud, Perrine, Axfors, Cathrine, Van’t Hooft, Janneke, Saccilotto, Ramon, Agarwal, Arnav, Appenzeller-Herzog, Christian, Contopoulos-Ioannidis, Despina G., Danchev, Valentin, Dirnagl, Ulrich, Ewald, Hannah, Gartlehner, Gerald, Goodman, Steven N., Haber, Noah A., Ioannidis, Angeliki Diotima, Ioannidis, John P. A., Lythgoe, Mark P., Ma, Wenyan, Macleod, Malcolm, Malički, Mario, et al. (2020). The worldwide clinical trial research response to the COVID-19 pandemic - the first 100 days. F1000Research, 9, 1193. https://doi.org/10.12688/f1000research.26707.1

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Kasenda, Benjamin, Liu, Junhao, Jiang, Yu, Gajewski, Byron, Wu, Cen, von Elm, Erik, Schandelmaier, Stefan, Moffa, Giusi, Trelle, Sven, Schmitt, Andreas Michael, Herbrand, Amanda K., Gloy, Viktoria, Speich, Benjamin, Hopewell, Sally, Hemkens, Lars G., Sluka, Constantin, McGill, Kris, Meade, Maureen, Cook, Deborah, et al. (2020). Prediction of RECRUITment In Randomized Clinical Trials (RECRUIT-IT) - Rationale and Design for an International Collaborative Study. Trials, 21(1), 731. https://doi.org/10.1186/s13063-020-04666-8

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Ladanie, Aviv, Schmitt, Andreas M., Speich, Benjamin, Naudet, Florian, Agarwal, Arnav, Pereira, Tiago V., Sclafani, Francesco, Herbrand, Amanda K., Briel, Matthias, Martin-Liberal, Juan, Schmid, Thomas, Ewald, Hannah, Ioannidis, John P. A., Bucher, Heiner C., Kasenda, Benjamin, & Hemkens, Lars G. (2020). Clinical trial evidence supporting US Food and Drug Administration approval of novel cancer therapies between 2000 and 2016. Jama Network Open, 3(11), e2024406. https://doi.org/10.1001/jamanetworkopen.2020.24406

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Odutayo A, Gryaznov D, Copsey B, Monk P, Speich B, Roberts C, Vadher K, Dutton P, Briel M, Hopewell S, Altman D.G., & ASPIRE study group . (2020). Design, analysis and reporting of multi-arm trials and strategies to address multiple testing. International Journal of Epidemiology, 49(3), 968–978. https://doi.org/10.1093/IJE/DYAA026

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Schandelmaier, Stefan, Schmitt, Andreas M., Herbrand, Amanda K., Glinz, Dominik, Ewald, Hannah, Briel, Matthias, Guyatt, Gordon H., Hemkens, Lars G., & Kasenda, Benjamin. (2020). Characteristics and interpretation of subgroup analyses based on tumour characteristics in randomised trials testing target-specific anticancer drugs: design of a systematic survey. BMJ Open, 10(5), e034565. https://doi.org/10.1136/bmjopen-2019-034565

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Speich, Benjamin, Gloy, Viktoria, Schur, Nadine, Ewald, Hannah, Hemkens, Lars G., Schwenkglenks, Matthias, Briel, Matthias, & MAking Randomized Trials Affordable Group. (2020). A scoping review shows that several nonvalidated budget planning tools for randomized trials are available. Journal of Clinical Epidemiology, 117, 9–19. https://doi.org/10.1016/j.jclinepi.2019.09.009

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Bastian, H., & Hemkens, L. G. (2019). Enough evidence and other endings: a descriptive study of stable Cochrane systematic reviews in 2019 [Posted-content]. Cold Spring Harbor Laboratory. https://doi.org/10.1101/19013912

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Schmitt AM, Herbrand AK, Fox CP, Bakunina K, Bromberg JEC, Cwynarski K, Doorduijn JK, Ferreri AJM, Illerhaus G, Issa S, Schorb E, Zucca E, Hemkens LG, Schandelmaier S, & Kasenda B. (2019). Rituximab in primary central nervous system lymphoma—A systematic review and meta-analysis. Hematological Oncology, 37(5), 548–557. https://doi.org/10.1002/hon.2666

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Hafner P, Bonati U, Klein A, Rubino D, Gocheva V, Schmidt S, Schroeder J, Bernert G, Laugel V, Steinlin M, Capone A, Gloor M, Bieri O, Hemkens LG, Speich B, Zumbrunn T, Gueven N, & Fischer D. (2019). Effect of combination l-citrulline and metformin treatment on motor function in patients with duchenne muscular dystrophy: A randomized clinical Trial. JAMA Network Open, 2(10), e1914171. https://doi.org/10.1001/jamanetworkopen.2019.14171

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Mc Cord KA, & Hemkens LG. (2019). Using electronic health records for clinical trials: Where do we stand and where can we go? CMAJ, 191(5), E128–E133. https://doi.org/10.1503/cmaj.180841

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Benchimol E.I., Smeeth L., Guttmann A., Harron K., Moher D., Petersen I., SOrensen H.T., Januel J., Von Elm E., Langan S.M., Altman D., De Klerk N., Hemkens L.G., Henry D., Le Pogam M., Manuel D., Patrick K., Perel P., Romano P.S., et al. (2019). The REporting of studies Conducted using Observational Routinely collected health Data (RECORD) statement: Guidelines for the reporting of studies conducted based on routinely collected health data La déclaration RECORD (Reporting of Studies Conducted Using Observational Routinely Collected Health Data): Directives pour la communication des études réalisées à partir de données de santé collectées en routine. Cmaj, 191(8), E216–E230. https://doi.org/10.1503/cmaj.181309

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Engelter, Stefan, Hemkens, Lars G, Speich, Benjamin, & Traenka, Christopher. (2019). Dopaminergic agents versus control for enhancing stroke recovery and rehabilitation. Cochrane Database of Systematic Reviews, 2019. https://doi.org/10.1002/14651858.cd013416

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