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2. Associations between daily step count classifications and continuous glucose monitoring metrics in adults with type 1 diabetes: analysis of the Type 1 Diabetes Exercise Initiative (T1DEXI) cohort

Author

Turner, Lauren V., Marak, Martin Chase, Gal, Robin L., Calhoun, Peter, Li, Zoey, Jacobs, Peter G., Clements, Mark A., Martin, Corby K., Doyle, III, Francis J., Patton, Susana R., Castle, Jessica R., Gillingham, Melanie B., Beck, Roy W., Rickels, Michael R., and Riddell, Michael C.

Published
2024
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3. Phylogenomics and the rise of the angiosperms

Author

Zuntini, Alexandre R., Carruthers, Tom, Maurin, Olivier, Bailey, Paul C., Leempoel, Kevin, Brewer, Grace E., Epitawalage, Niroshini, Françoso, Elaine, Gallego-Paramo, Berta, McGinnie, Catherine, Negrão, Raquel, Roy, Shyamali R., Simpson, Lalita, Toledo Romero, Eduardo, Barber, Vanessa M. A., Botigué, Laura, Clarkson, James J., Cowan, Robyn S., Dodsworth, Steven, Johnson, Matthew G., Kim, Jan T., Pokorny, Lisa, Wickett, Norman J., Antar, Guilherme M., DeBolt, Lucinda, Gutierrez, Karime, Hendriks, Kasper P., Hoewener, Alina, Hu, Ai-Qun, Joyce, Elizabeth M., Kikuchi, Izai A. B. S., Larridon, Isabel, Larson, Drew A., de Lírio, Elton John, Liu, Jing-Xia, Malakasi, Panagiota, Przelomska, Natalia A. S., Shah, Toral, Viruel, Juan, Allnutt, Theodore R., Ameka, Gabriel K., Andrew, Rose L., Appelhans, Marc S., Arista, Montserrat, Ariza, María Jesús, Arroyo, Juan, Arthan, Watchara, Bachelier, Julien B., Bailey, C. Donovan, Barnes, Helen F., Barrett, Matthew D., Barrett, Russell L., Bayer, Randall J., Bayly, Michael J., Biffin, Ed, Biggs, Nicky, Birch, Joanne L., Bogarín, Diego, Borosova, Renata, Bowles, Alexander M. C., Boyce, Peter C., Bramley, Gemma L. C., Briggs, Marie, Broadhurst, Linda, Brown, Gillian K., Bruhl, Jeremy J., Bruneau, Anne, Buerki, Sven, Burns, Edie, Byrne, Margaret, Cable, Stuart, Calladine, Ainsley, Callmander, Martin W., Cano, Ángela, Cantrill, David J., Cardinal-McTeague, Warren M., Carlsen, Mónica M., Carruthers, Abigail J. A., de Castro Mateo, Alejandra, Chase, Mark W., Chatrou, Lars W., Cheek, Martin, Chen, Shilin, Christenhusz, Maarten J. M., Christin, Pascal-Antoine, Clements, Mark A., Coffey, Skye C., Conran, John G., Cornejo, Xavier, Couvreur, Thomas L. P., Cowie, Ian D., Csiba, Laszlo, Darbyshire, Iain, Davidse, Gerrit, Davies, Nina M. J., Davis, Aaron P., van Dijk, Kor-jent, Downie, Stephen R., Duretto, Marco F., Duvall, Melvin R., Edwards, Sara L., Eggli, Urs, Erkens, Roy H. J., Escudero, Marcial, de la Estrella, Manuel, Fabriani, Federico, Fay, Michael F., Ferreira, Paola de L., Ficinski, Sarah Z., Fowler, Rachael M., Frisby, Sue, Fu, Lin, Fulcher, Tim, Galbany-Casals, Mercè, Gardner, Elliot M., German, Dmitry A., Giaretta, Augusto, Gibernau, Marc, Gillespie, Lynn J., González, Cynthia C., Goyder, David J., Graham, Sean W., Grall, Aurélie, Green, Laura, Gunn, Bee F., Gutiérrez, Diego G., Hackel, Jan, Haevermans, Thomas, Haigh, Anna, Hall, Jocelyn C., Hall, Tony, Harrison, Melissa J., Hatt, Sebastian A., Hidalgo, Oriane, Hodkinson, Trevor R., Holmes, Gareth D., Hopkins, Helen C. F., Jackson, Christopher J., James, Shelley A., Jobson, Richard W., Kadereit, Gudrun, Kahandawala, Imalka M., Kainulainen, Kent, Kato, Masahiro, Kellogg, Elizabeth A., King, Graham J., Klejevskaja, Beata, Klitgaard, Bente B., Klopper, Ronell R., Knapp, Sandra, Koch, Marcus A., Leebens-Mack, James H., Lens, Frederic, Leon, Christine J., Léveillé-Bourret, Étienne, Lewis, Gwilym P., Li, De-Zhu, Li, Lan, Liede-Schumann, Sigrid, Livshultz, Tatyana, Lorence, David, Lu, Meng, Lu-Irving, Patricia, Luber, Jaquelini, Lucas, Eve J., Luján, Manuel, Lum, Mabel, Macfarlane, Terry D., Magdalena, Carlos, Mansano, Vidal F., Masters, Lizo E., Mayo, Simon J., McColl, Kristina, McDonnell, Angela J., McDougall, Andrew E., McLay, Todd G. B., McPherson, Hannah, Meneses, Rosa I., Merckx, Vincent S. F. T., Michelangeli, Fabián A., Mitchell, John D., Monro, Alexandre K., Moore, Michael J., Mueller, Taryn L., Mummenhoff, Klaus, Munzinger, Jérôme, Muriel, Priscilla, Murphy, Daniel J., Nargar, Katharina, Nauheimer, Lars, Nge, Francis J., Nyffeler, Reto, Orejuela, Andrés, Ortiz, Edgardo M., Palazzesi, Luis, Peixoto, Ariane Luna, Pell, Susan K., Pellicer, Jaume, Penneys, Darin S., Perez-Escobar, Oscar A., Persson, Claes, Pignal, Marc, Pillon, Yohan, Pirani, José R., Plunkett, Gregory M., Powell, Robyn F., Prance, Ghillean T., Puglisi, Carmen, Qin, Ming, Rabeler, Richard K., Rees, Paul E. J., Renner, Matthew, Roalson, Eric H., Rodda, Michele, Rogers, Zachary S., Rokni, Saba, Rutishauser, Rolf, de Salas, Miguel F., Schaefer, Hanno, Schley, Rowan J., Schmidt-Lebuhn, Alexander, Shapcott, Alison, Al-Shehbaz, Ihsan, Shepherd, Kelly A., Simmons, Mark P., Simões, André O., Simões, Ana Rita G., Siros, Michelle, Smidt, Eric C., Smith, James F., Snow, Neil, Soltis, Douglas E., Soltis, Pamela S., Soreng, Robert J., Sothers, Cynthia A., Starr, Julian R., Stevens, Peter F., Straub, Shannon C. K., Struwe, Lena, Taylor, Jennifer M., Telford, Ian R. H., Thornhill, Andrew H., Tooth, Ifeanna, Trias-Blasi, Anna, Udovicic, Frank, Utteridge, Timothy M. A., Del Valle, Jose C., Verboom, G. Anthony, Vonow, Helen P., Vorontsova, Maria S., de Vos, Jurriaan M., Al-Wattar, Noor, Waycott, Michelle, Welker, Cassiano A. D., White, Adam J., Wieringa, Jan J., Williamson, Luis T., Wilson, Trevor C., Wong, Sin Yeng, Woods, Lisa A., Woods, Roseina, Worboys, Stuart, Xanthos, Martin, Yang, Ya, Zhang, Yu-Xiao, Zhou, Meng-Yuan, Zmarzty, Sue, Zuloaga, Fernando O., Antonelli, Alexandre, Bellot, Sidonie, Crayn, Darren M., Grace, Olwen M., Kersey, Paul J., Leitch, Ilia J., Sauquet, Hervé, Smith, Stephen A., Eiserhardt, Wolf L., Forest, Félix, and Baker, William J.

Published
2024
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4. A Glycemia Risk Index (GRI) of Hypoglycemia and Hyperglycemia for Continuous Glucose Monitoring Validated by Clinician Ratings

Author

Klonoff, David C, Wang, Jing, Rodbard, David, Kohn, Michael A, Li, Chengdong, Liepmann, Dorian, Kerr, David, Ahn, David, Peters, Anne L, Umpierrez, Guillermo E, Seley, Jane Jeffrie, Xu, Nicole Y, Nguyen, Kevin T, Simonson, Gregg, Agus, Michael SD, Al-Sofiani, Mohammed E, Armaiz-Pena, Gustavo, Bailey, Timothy S, Basu, Ananda, Battelino, Tadej, Bekele, Sewagegn Yeshiwas, Benhamou, Pierre-Yves, Bequette, B Wayne, Blevins, Thomas, Breton, Marc D, Castle, Jessica R, Chase, James Geoffrey, Chen, Kong Y, Choudhary, Pratik, Clements, Mark A, Close, Kelly L, Cook, Curtiss B, Danne, Thomas, Doyle, Francis J, Drincic, Angela, Dungan, Kathleen M, Edelman, Steven V, Ejskjaer, Niels, Espinoza, Juan C, Fleming, G Alexander, Forlenza, Gregory P, Freckmann, Guido, Galindo, Rodolfo J, Gomez, Ana Maria, Gutow, Hanna A, Heinemann, Lutz, Hirsch, Irl B, Hoang, Thanh D, Hovorka, Roman, Jendle, Johan H, Ji, Linong, Joshi, Shashank R, Joubert, Michael, Koliwad, Suneil K, Lal, Rayhan A, Lansang, M Cecilia, Lee, Wei-An, Leelarathna, Lalantha, Leiter, Lawrence A, Lind, Marcus, Litchman, Michelle L, Mader, Julia K, Mahoney, Katherine M, Mankovsky, Boris, Masharani, Umesh, Mathioudakis, Nestoras N, Mayorov, Alexander, Messler, Jordan, Miller, Joshua D, Mohan, Viswanathan, Nichols, James H, Nørgaard, Kirsten, O’Neal, David N, Pasquel, Francisco J, Philis-Tsimikas, Athena, Pieber, Thomas, Phillip, Moshe, Polonsky, William H, Pop-Busui, Rodica, Rayman, Gerry, Rhee, Eun-Jung, Russell, Steven J, Shah, Viral N, Sherr, Jennifer L, Sode, Koji, Spanakis, Elias K, Wake, Deborah J, Waki, Kayo, Wallia, Amisha, Weinberg, Melissa E, Wolpert, Howard, Wright, Eugene E, Zilbermint, Mihail, and Kovatchev, Boris

Subjects
Biomedical and Clinical Sciences, Nutrition and Dietetics, Diabetes, Adult, Humans, Blood Glucose, Blood Glucose Self-Monitoring, Hypoglycemia, Hyperglycemia, Glucose, ambulatory glucose profile, composite metric, continuous glucose monitor, diabetes, glycemia risk index, hyperglycemia, hypoglycemia, time in range, Nutrition and dietetics
Abstract

BackgroundA composite metric for the quality of glycemia from continuous glucose monitor (CGM) tracings could be useful for assisting with basic clinical interpretation of CGM data.MethodsWe assembled a data set of 14-day CGM tracings from 225 insulin-treated adults with diabetes. Using a balanced incomplete block design, 330 clinicians who were highly experienced with CGM analysis and interpretation ranked the CGM tracings from best to worst quality of glycemia. We used principal component analysis and multiple regressions to develop a model to predict the clinician ranking based on seven standard metrics in an Ambulatory Glucose Profile: very low-glucose and low-glucose hypoglycemia; very high-glucose and high-glucose hyperglycemia; time in range; mean glucose; and coefficient of variation.ResultsThe analysis showed that clinician rankings depend on two components, one related to hypoglycemia that gives more weight to very low-glucose than to low-glucose and the other related to hyperglycemia that likewise gives greater weight to very high-glucose than to high-glucose. These two components should be calculated and displayed separately, but they can also be combined into a single Glycemia Risk Index (GRI) that corresponds closely to the clinician rankings of the overall quality of glycemia (r = 0.95). The GRI can be displayed graphically on a GRI Grid with the hypoglycemia component on the horizontal axis and the hyperglycemia component on the vertical axis. Diagonal lines divide the graph into five zones (quintiles) corresponding to the best (0th to 20th percentile) to worst (81st to 100th percentile) overall quality of glycemia. The GRI Grid enables users to track sequential changes within an individual over time and compare groups of individuals.ConclusionThe GRI is a single-number summary of the quality of glycemia. Its hypoglycemia and hyperglycemia components provide actionable scores and a graphical display (the GRI Grid) that can be used by clinicians and researchers to determine the glycemic effects of prescribed and investigational treatments.

Published
2023

7. Approximation Methods for Mixed Models with Probit Link Functions

Author

Christoffersen, Benjamin, Clements, Mark, Kjellström, Hedvig, and Humphreys, Keith

Subjects
Statistics - Computation, Statistics - Methodology
Abstract

We study approximation methods for a large class of mixed models with a probit link function that includes mixed versions of the binomial model, the multinomial model, and generalized survival models. The class of models is special because the marginal likelihood can be expressed as Gaussian weighted integrals or as multivariate Gaussian cumulative density functions. The latter approach is unique to the probit link function models and has been proposed for parameter estimation in complex, mixed effects models. However, it has not been investigated in which scenarios either form is preferable. Our simulations and data example show that neither form is preferable in general and give guidance on when to approximate the cumulative density functions and when to approximate the Gaussian weighted integrals and, in the case of the latter, which general purpose method to use among a large list of methods., Comment: 33 pages, 2 figures, and 9 tables

Published
2021

11. Asymptotically Exact and Fast Gaussian Copula Models for Imputation of Mixed Data Types

Author

Christoffersen, Benjamin, Clements, Mark, Humphreys, Keith, and Kjellström, Hedvig

Subjects
Statistics - Machine Learning, Computer Science - Machine Learning, Statistics - Applications, Statistics - Computation
Abstract

Missing values with mixed data types is a common problem in a large number of machine learning applications such as processing of surveys and in different medical applications. Recently, Gaussian copula models have been suggested as a means of performing imputation of missing values using a probabilistic framework. While the present Gaussian copula models have shown to yield state of the art performance, they have two limitations: they are based on an approximation that is fast but may be imprecise and they do not support unordered multinomial variables. We address the first limitation using direct and arbitrarily precise approximations both for model estimation and imputation by using randomized quasi-Monte Carlo procedures. The method we provide has lower errors for the estimated model parameters and the imputed values, compared to previously proposed methods. We also extend the previous Gaussian copula models to include unordered multinomial variables in addition to the present support of ordinal, binary, and continuous variables., Comment: 20 pages, 1 figures, and 4 tables

Published
2021

13. A flexible parametric accelerated failure time model

Author

Crowther, Michael J., Royston, Patrick, and Clements, Mark

Subjects
Statistics - Methodology
Abstract

Accelerated failure time (AFT) models are used widely in medical research, though to a much lesser extent than proportional hazards models. In an AFT model, the effect of covariates act to accelerate or decelerate the time to event of interest, i.e. shorten or extend the time to event. Commonly used parametric AFT models are limited in the underlying shapes that they can capture. In this article, we propose a general parametric AFT model, and in particular concentrate on using restricted cubic splines to model the baseline to provide substantial flexibility. We then extend the model to accommodate time-dependent acceleration factors. Delayed entry is also allowed, and hence, time-dependent covariates. We evaluate the proposed model through simulation, showing substantial improvements compared to standard parametric AFT models. We also show analytically and through simulations that the AFT models are collapsible, suggesting that this model class will be well suited to causal inference. We illustrate the methods with a dataset of patients with breast cancer. User friendly Stata and R software packages are provided.

Published
2020

16. Identification of areas of grading difficulties in prostate cancer and comparison with artificial intelligence assisted grading.

Author

Egevad, Lars, Swanberg, Daniela, Delahunt, Brett, Ström, Peter, Kartasalo, Kimmo, Olsson, Henrik, Berney, Dan, Bostwick, David, Evans, Andrew, Humphrey, Peter, Iczkowski, Kenneth, Kench, James, Kristiansen, Glen, Leite, Katia, McKenney, Jesse, Oxley, Jon, Pan, Chin-Chen, Samaratunga, Hemamali, Srigley, John, Takahashi, Hiroyuki, Tsuzuki, Toyonori, van der Kwast, Theo, Varma, Murali, Zhou, Ming, Clements, Mark, and Eklund, Martin

Subjects
Artificial intelligence, Grading, Pathology, Prostate cancer, Reproducibility, Standardization, Artificial Intelligence, Databases, Factual, Humans, Image Interpretation, Computer-Assisted, Male, Neoplasm Grading, Observer Variation, Prostatic Neoplasms
Abstract

The International Society of Urological Pathology (ISUP) hosts a reference image database supervised by experts with the purpose of establishing an international standard in prostate cancer grading. Here, we aimed to identify areas of grading difficulties and compare the results with those obtained from an artificial intelligence system trained in grading. In a series of 87 needle biopsies of cancers selected to include problematic cases, experts failed to reach a 2/3 consensus in 41.4% (36/87). Among consensus and non-consensus cases, the weighted kappa was 0.77 (range 0.68-0.84) and 0.50 (range 0.40-0.57), respectively. Among the non-consensus cases, four main causes of disagreement were identified: the distinction between Gleason score 3 + 3 with tangential cutting artifacts vs. Gleason score 3 + 4 with poorly formed or fused glands (13 cases), Gleason score 3 + 4 vs. 4 + 3 (7 cases), Gleason score 4 + 3 vs. 4 + 4 (8 cases) and the identification of a small component of Gleason pattern 5 (6 cases). The AI system obtained a weighted kappa value of 0.53 among the non-consensus cases, placing it as the observer with the sixth best reproducibility out of a total of 24. AI may serve as a decision support and decrease inter-observer variability by its ability to make consistent decisions. The grading of these cancer patterns that best predicts outcome and guides treatment warrants further clinical and genetic studies. Results of such investigations should be used to improve calibration of AI systems.

Published
2020

19. Efficacy and safety of the SGLT2 inhibitor empagliflozin versus placebo and the DPP-4 inhibitor linagliptin versus placebo in young people with type 2 diabetes (DINAMO): a multicentre, randomised, double-blind, parallel group, phase 3 trial

Author

Bardymova, Tatiana, Barrientos Perez, Margarita, Bethin, Kathleen, Bjornstad, Petter, Bondar, Irina, Chen, Mimi, Choi, Jin-Ho, Clements, Mark A, Colomar, Javier Ricardo, Daniels, Mark, Deerochanawong, Chaicharn, Desai, Vivek S, Desmangles, Jean-Claude G, Dillon, Robert G, Dixit, Naznin M, Du, Hongwei, Edelen, Rachel, Espinoza Peralta, Diego, Felipe Gacioppo, María Verónica, Ferraz, Tania Maria Bulcão Lousada, Galkina, Galina, Gallagher, Mary Patricia, George, Minu, Gonzalez, Edgar, Gottschalk, Michael Everett, Guido, Giancarlo, Hassan, Amir Ali, Hershkovitz, Eli, Huerta-Saenz, Lina P, Hwang, Jin Soon, Ibarra Gomez, Jaime Orlando, Irizarry Gonzalez, Lydia, Jain, Nina, Jelley, David H, Kim, Ho-Seong, Kovalenko, Tatiana, Laffel, Lori Michelle B, Leichter, Steven B, Liberatore Jr, Raphael Del Roio, Lynch, Jane, Mahmud, Farid Hussain, Malievskiy, Oleg Arturovich, Muir, Andrew, Nelson, Bryce A, Nevarez Ruiz, Luis Alejandro, Olson, Micah L, Pelayo Orozco, Emilia Susana, Peterkova, Valentina, Ramírez Mendoza, Fernando Ramón, Reddy, Konda Mohan, Rodriguez, Henry, Saenz, Javier Andres, Samoilova, Julia, Schwab, Karl-Otfried, Shah, Sejal H, Shehadeh, Naim, Shoemaker, Ashley H, Skorodok, Yulia, Sobolev, Aleksandr, Solís, Silvana Ernestina, Srinivasan, Shylaja, Tamborlane, William V, Tsalikian, Eva, Valeeva, Farida, Vance, Carl D, Velasquez-Mieyer, Pedro A, Violante Ortiz, Rafael Margarito, Votyakova, Olga, Wei, Haiyan, Weinstock, Ruth S, Wheeler, Mark D, Wicklow, Brandy Alexandra, Willi, Steven M, Wintergerst, Kupper A, Wolf, Risa M, Wood, Jamie Ruth, Yaliwal, Chandan, Yupanqui Lozno, Hernán, Laffel, Lori M, Danne, Thomas, Klingensmith, Georgeanna J, Willi, Steven, Zeitler, Philip, Neubacher, Dietmar, and Marquard, Jan

Published
2023
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20. SMART Teaching in New and Old Classrooms

Author

Saunders, Gunter, Oradini, Federica, and Clements, Mark

Abstract

The University of Westminster is undertaking a major classroom refurbishment program that is linked to a new approach to staff development in mobile learning. Feedback obtained from academic staff and students previously highlighted how classrooms should be changed so as to promote more active forms of curriculum delivery. Both technology and classroom furniture were considered significant enablers for effective in-class delivery, with the simplicity of the former and flexibility of the latter identified as key. To date nearly 70 classrooms have been re-designed and the impact of the changes on both staff and students has been assessed. Generally, the feedback has been positive with high praise for the easy to use technology solutions provided and the adaptability of the furniture. In addition, the significance of 'getting right' basic features in new classrooms (lighting, acoustics for example) was frequently cited by staff and students. This paper will highlight the features of new classrooms that students and staff have indicated they feel are most significant for their learning and teaching experiences. The paper will also assess the extent to which the new classrooms have been successful through analyzing the impact of both new technology and furniture arrangements on approaches to curriculum delivery. In addition, staff views on the utility of the new staff development approach will be discussed.

Published
2017

22. Impact of model misspecification in shared frailty survival models

Author

Gasparini, Alessandro, Clements, Mark S., Abrams, Keith R., and Crowther, Michael J.

Subjects
Statistics - Methodology
Abstract

Survival models incorporating random effects to account for unmeasured heterogeneity are being increasingly used in biostatistical and applied research. Specifically, unmeasured covariates whose lack of inclusion in the model would lead to biased, inefficient results are commonly modelled by including a subject-specific (or cluster-specific) frailty term that follows a given distribution (e.g. Gamma or log-Normal). Despite that, in the context of parametric frailty models little is known about the impact of misspecifying the baseline hazard, the frailty distribution, or both. Therefore, our aim is to quantify the impact of such misspecification in a wide variety of clinically plausible scenarios via Monte Carlo simulation, using open source software readily available to applied researchers. We generate clustered survival data assuming various baseline hazard functions, including mixture distributions with turning points, and assess the impact of sample size, variance of the frailty, baseline hazard function, and frailty distribution. Models compared include standard parametric distributions and more flexible spline-based approaches; we also included semiparametric Cox models. The resulting bias can be clinically relevant. In conclusion, we highlight the importance of fitting models that are flexible enough and the importance of assessing model fit. We illustrate our conclusions with two applications using data on diabetic retinopathy and bladder cancer. Our results show the importance of assessing model fit with respect to the baseline hazard function and the distribution of the frailty: misspecifying the former leads to biased relative and absolute risk estimates while misspecifying the latter affects absolute risk estimates and measures of heterogeneity.

Published
2018
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23. Low-Dose Anti-Thymocyte Globulin Preserves C-Peptide, Reduces HbA1c, and Increases Regulatory to Conventional T-Cell Ratios in New-Onset Type 1 Diabetes: Two-Year Clinical Trial Data

Author

Haller, Michael J, Long, S Alice, Blanchfield, J Lori, Schatz, Desmond A, Skyler, Jay S, Krischer, Jeffrey P, Bundy, Brian N, Geyer, Susan M, Warnock, Megan V, Miller, Jessica L, Atkinson, Mark A, Becker, Dorothy J, Baidal, David A, DiMeglio, Linda A, Gitelman, Stephen E, Goland, Robin, Gottlieb, Peter A, Herold, Kevan C, Marks, Jennifer B, Moran, Antoinette, Rodriguez, Henry, Russell, William E, Wilson, Darrell M, Greenbaum, Carla J, Battaglia, Manuela, Becker, Dorothy, Bingley, Penelope, Bosi, Emanuele, Buckner, Jane, Clements, Mark, Colman, Peter G, DiMeglio, Linda, Evans-Molina, Carmella, Gottlieb, Peter, Herold, Kevan, Knip, Mikael, Lernmark, Ake, Moore, Wayne, Muir, Andrew, Palmer, Jerry, Peakman, Mark, Philipson, Louis, Raskin, Philip, Redondo, Maria, Russell, William, Sosenko, Jay M, Spain, Lisa, Wentworth, John, Wherrett, Diane, Winter, William, Ziegler, Anette, Anderson, Mark, Antinozzi, Peter, Insel, Richard, Kay, Thomas, Pugliese, Alberto, Roep, Bart, Toppari, Jorma, Leschek, Ellen, Bourcier, Katarzyna, Ridge, John, Rafkin, Lisa, Santiago, Irene, Bundy, Brian, Abbondondolo, Michael, Adams, Timothy, Asif, Ilma, Bjellquist, Jenna, Boonstra, Matthew, Burroughs, Cristina, Cleves, Mario, Cuthbertson, David, DeSalvatore, Meagan, Eberhard, Christopher, Fiske, Steve, Ford, Julie, Garmeson, Jennifer, Geyer, Susan, and Hays, Brian

Subjects
Prevention, Diabetes, Clinical Trials and Supportive Activities, Clinical Research, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Metabolic and endocrine, Adolescent, Adult, Antilymphocyte Serum, C-Peptide, CD4-CD8 Ratio, Child, Diabetes Mellitus, Type 1, Double-Blind Method, Female, Flow Cytometry, Glycated Hemoglobin, Granulocyte Colony-Stimulating Factor, Humans, Immunologic Factors, Male, T-Lymphocytes, Regulatory, Young Adult, Type 1 Diabetes TrialNet ATG-GCSF Study Group, Medical and Health Sciences, Endocrinology & Metabolism
Abstract

A three-arm, randomized, double-masked, placebo-controlled phase 2b trial performed by the Type 1 Diabetes TrialNet Study Group previously demonstrated that low-dose anti-thymocyte globulin (ATG) (2.5 mg/kg) preserved β-cell function and reduced HbA1c for 1 year in new-onset type 1 diabetes. Subjects (N = 89) were randomized to 1) ATG and pegylated granulocyte colony-stimulating factor (GCSF), 2) ATG alone, or 3) placebo. Herein, we report 2-year area under the curve (AUC) C-peptide and HbA1c, prespecified secondary end points, and potential immunologic correlates. The 2-year mean mixed-meal tolerance test-stimulated AUC C-peptide, analyzed by ANCOVA adjusting for baseline C-peptide, age, and sex (n = 82) with significance defined as one-sided P < 0.025, was significantly higher in subjects treated with ATG versus placebo (P = 0.00005) but not ATG/GCSF versus placebo (P = 0.032). HbA1c was significantly reduced at 2 years in subjects treated with ATG (P = 0.011) and ATG/GCSF (P = 0.022) versus placebo. Flow cytometry analyses demonstrated reduced circulating CD4:CD8 ratio, increased regulatory T-cell:conventional CD4 T-cell ratios, and increased PD-1+CD4+ T cells following low-dose ATG and ATG/GCSF. Low-dose ATG partially preserved β-cell function and reduced HbA1c 2 years after therapy in new-onset type 1 diabetes. Future studies should determine whether low-dose ATG might prevent or delay the onset of type 1 diabetes.

Published
2019

25. Impact of diabetes status and related factors on COVID-19-associated hospitalization: A nationwide retrospective cohort study of 116,370 adults with SARS-CoV-2 infection

Author

Tallon, Erin M., Ebekozien, Osagie, Sanchez, Janine, Staggs, Vincent S., Ferro, Diana, McDonough, Ryan, Demeterco-Berggren, Carla, Polsky, Sarit, Gomez, Patricia, Patel, Neha, Prahalad, Priya, Odugbesan, Ori, Mathias, Priyanka, Lee, Joyce M., Smith, Chelsey, Shyu, Chi-Ren, and Clements, Mark A.

Published
2022
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32. Early Results of an Innovative Scalable Digital Treatment for Diabetes Distress in Families of School-Age Children with Type 1 Diabetes.

Author

Patton, Susana R., Pierce, Jessica S., Kahhan, Nicole, Benson, Matthew, Clements, Mark A., and Fox, Larry A.

Subjects
TYPE 1 diabetes, PSYCHOLOGICAL distress, RESEARCH funding, PARENT-child relationships, MINDFULNESS, STATISTICAL sampling, QUESTIONNAIRES, TREATMENT effectiveness, DESCRIPTIVE statistics, CHI-squared test, RANDOMIZED controlled trials, TELEMEDICINE, VIDEOCONFERENCING, ANALYSIS of variance, PSYCHOLOGY of parents, COGNITIVE therapy, DATA analysis software, PATIENT satisfaction
Abstract

Objective: This paper reports on the initial outcomes of a new mHealth intervention to reduce diabetes distress (DD) in families of school-age children living with type 1 diabetes (T1D) entitled, 'Remedy to Diabetes Distress' (R2D2). Methods: We randomized 34 families (mean child age = 10 ± 1.4 years; 53% male, 85% White, mean HbA1c = 7.24 ± 0.71%) to one of three delivery arms differing only by number of telehealth visits over a 10-week period: zero visits = self-guided (SG), three visits = enhanced self-guided (ESG), or eight visits = video visits (VV). All families had 24 × 7 access to digital treatment materials for 10 weeks. We examined the feasibility and acceptability of R2D2. We used the Problem Areas in Diabetes-Child (PPAIDC and PAIDC, parent and child, respectively) to examine treatment effects by time and delivery arm. We performed sensitivity analyses to characterize families who responded to R2D2. Results: It was feasible for families to access R2D2 mHealth content independently, though attendance at telehealth visits was variable. Parents and children reported high satisfaction scores. There were significant pre-post reductions in PPAIDC (p = 0.026) and PAIDC (p = 0.026) scores but no differences by delivery arm. There were no differences in child age, sex, race, or pre-treatment HbA1c for responders versus non-responders, though families who responded reported higher PPAID-C scores pre-treatment (p = 0.01) and tended to report shorter diabetes duration (p = 0.08). Conclusions: Initial results support the acceptability and treatment effects of R2D2 regardless of the frequency of adjunctive virtual visits. Characterizing responders may help to identify families who could benefit from R2D2 in the future. [ABSTRACT FROM AUTHOR]

Published
2024
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35. Utility of Pathology Imagebase for standardisation of prostate cancer grading.

Author

Egevad, Lars, Delahunt, Brett, Berney, Daniel, Bostwick, David, Cheville, John, Comperat, Eva, Evans, Andrew, Fine, Samson, Grignon, David, Humphrey, Peter, Hörnblad, Jonas, Iczkowski, Kenneth, Kench, James, Kristiansen, Glen, Leite, Katia, Magi-Galluzzi, Cristina, McKenney, Jesse, Oxley, Jon, Pan, Chin-Chen, Samaratunga, Hemamali, Srigley, John, Takahashi, Hiroyuki, True, Lawrence, Tsuzuki, Toyonori, van der Kwast, Theo, Varma, Murali, Zhou, Ming, and Clements, Mark

Subjects
International Society of Urological Pathology, database, grading, prostate, standardisation, Databases, Factual, Humans, Male, Neoplasm Grading, Pathology, Clinical, Prostatic Neoplasms
Abstract

AIMS: Despite efforts to standardise grading of prostate cancer, even among experts there is still a considerable variation in grading practices. In this study we describe the use of Pathology Imagebase, a novel reference image library, for setting an international standard in prostate cancer grading. METHODS AND RESULTS: The International Society of Urological Pathology (ISUP) recently launched a reference image database supervised by experts. A panel of 24 international experts in prostate pathology reviewed independently microphotographs of 90 cases of prostate needle biopsies with cancer. A linear weighted kappa of 0.67 (95% confidence interval = 0.62-0.72) and consensus was reached in 50 cases. The interobserver weighted kappa varied from 0.48 to 0.89. The highest level of agreement was seen for Gleason score (GS) 3 + 3 = 6 (ISUP grade 1), while higher grades and particularly GS 4 + 3 = 7 (ISUP grade 3) showed considerable disagreement. Once a two-thirds majority was reached, images were moved automatically into a public database available for all ISUP members at www.isupweb.org. Non-members are able to access a limited number of cases. CONCLUSIONS: It is anticipated that the database will assist pathologists to calibrate their grading and, hence, decrease interobserver variability. It will also help to identify instances where definitions of grades need to be clarified.

Published
2018

39. Exploring computer mediated communications in Facebook for an insight into enhancing uptake and usage in higher education for social, educational and institutional benefit

Author

Clements, Mark Michael, Goddard, William, and Barnard, Jane

Subjects
378.1, LB Theory and practice of education
Abstract

In the UK, technology enhanced learning is seen as a way of enhancing student engagement and collaboration. Recent literature suggests that some of the attempts to integrate social media into formal teaching in higher education (HE) have suffered from student privacy issues leading to low student participation. This thesis explored the use of Facebook in HE, discussed shortcomings in digital signal transmission affecting intersubjective accord and employed Goffman's embarrassment avoidance framework, communication privacy management and social penetration theories to model student behaviour on and offline to offer insights into the realities of student Facebook usage in HE. The research followed a pragmatist paradigm and focused upon Facebook usage in a post-1992 university, exploring student emotions and privacy boundaries. Facebook data recording and an online survey provided data from 22 students. Results from the sample indicated a preference for face-to face teaching methods, similar levels of trustworthiness accorded to staff as they would for senior colleagues at work and that those who became embarrassed more easily shared fewer items on Facebook. When making a privacy boundary decision, the nature of the shared object had a greater influence than the personal network with which it was to be shared. The conclusion is that Facebook has limited potential at the front of the classroom, however private Facebook study groups can be a source of peer feedback and social support with the potential to increase individual learning outcomes, cohesion and interaction, directly and indirectly benefiting HE. This thesis suggests changes to HE social networking policies to encourage student participation in social media and that greater emphasis should be placed upon copresent methods of teaching.

Published
2017

40. Prostate cancer screening using a combination of risk-prediction, MRI, and targeted prostate biopsies (STHLM3-MRI): a prospective, population-based, randomised, open-label, non-inferiority trial

Author

Cavalli-Björkman, Carin, Björklund, Astrid, Hune, Britt-Marie, Clements, Mark, Hao, Shuang, Discacciati, Andrea, Grönberg, Henrik, Eklund, Martin, Nordström, Tobias, Carlsson, Stefan, Aly, Markus, Walldén, Mats, Steinberg, Ola, Andersson, Karl, Jäderling, Fredrik, Wimmercranz, Fredrik, Meurling, Edward, Gleassgen, Axel, Majeed, Nada, Awadelkarim, Rihab, Fyhr, Ing-Marie, Sandström, Dag, Waage, Linda, Imamov, Otabek, Lantz, Rafael, Thorstensson, Andreas, Stiernstedt, Carl, Wande, Dushaid, Trygg, Gunnar, Söderbäck, Harald, Michajlowski, Jerzy, Leykamm, Lars, Svedberg, Nils-Erik, Bergman, Tommy, Sabockis, Raimundas, Akrawi, Sirvan, Bergman, Martin, Annerstedt, Magnus, and Glaessgen, Axel

Published
2021
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41. Top world broiler and egg rankings 2024.

Author

CLEMENTS, MARK

Subjects
CHICKEN as food, POULTRY litter, ANIMAL culture, AGRICULTURAL technology, BUSINESS names, EGG industry
Abstract

The article "Top world broiler and egg rankings 2024" from WATT Poultry Trends provides a comprehensive overview of the top broiler and egg producers globally. The demand for chicken meat is on the rise, with Brazil's JBS leading the broiler ranking by producing 4,436 million broilers annually. In the egg industry, the U.S.-based Cal-Maine Foods is the largest producer with 44.5 million layers. The rankings highlight the global nature of the poultry industry, with companies from various regions contributing significantly to meet consumer demand. [Extracted from the article]

Published
2024

43. Multicenter Evaluation of Ultra-Rapid Lispro Insulin with Control-IQ Technology in Adults, Adolescents, and Children with Type 1 Diabetes.

Author

Levy, Carol J., Bailey, Ryan, Laffel, Lori M., Forlenza, Gregory, DiMeglio, Linda A., Hughes, Michael S., Brown, Sue A., Aleppo, Grazia, Bhargava, Anuj, Shah, Viral N., Clements, Mark A., Kipnes, Mark, Bruggeman, Brittany, Daniels, Mark, Rodriguez, Henry, Calhoun, Peter, Lum, John W., Sasson-Katchalski, Ravid, Pinsker, Jordan E., and Pollom, Robyn

Published
2024
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44. Spatio-temporal variation in prostate cancer testing in Stockholm: A population-based study.

Author

Rai, Balram, Nordström, Tobias, Lantz, Anna, Lund, Rolf Lyneborg, Kuja-Halkola, Ralf, Rado, Marta, Öberg, Sara, Hao, Shuang, Du, Xiaoyang, and Clements, Mark

Subjects
SPATIO-temporal variation, CANCER diagnosis, PROSTATE-specific antigen, OLDER men, SPATIAL variation
Abstract

Prostate cancer screening using prostate-specific antigen (PSA) testing is controversial but remains prevalent in many countries. There is little information in Sweden or elsewhere on the spatial variation in PSA testing. This study aims to describe the spatio-temporal variation in PSA testing prior to a prostate cancer diagnosis in the Stockholm region at the municipality and small area levels. A population-based register study comprised men aged 40 years and over living in the Stockholm region during 2007–2016. For Stockholm in 2016, we reported the proportion of men who had a PSA test for the preceding one, two, five and ten years by ten-year age groups. The age-standardised proportion of men having a PSA test was reported for municipalities by calendar years. We used spatial smoothing for calculating the age-standardised proportion of men having a PSA test in a small area for each calendar year. In 2016, 74.0% and 77.8% of men aged 60–69 and 70–79 years respectively had taken a PSA test in the previous ten years. The municipalities of Danderyd and Ekerö showed high proportions of PSA testing. A marked heterogeneity in such proportions within each municipality was observed. The odds ratio for having a PSA test for those born in Sweden was 2.22 (95% CI 2.00–2.52). Opportunistic PSA testing is widespread with three quarters of men in their sixties and seventies having had a test in the preceding decade. We found evidence for marked geographical heterogeneity, where more affluent and metropolitan areas had higher levels of testing. Variations in PSA testing was associated with socio-economic position and demographic factors including education, income and country of birth. [ABSTRACT FROM AUTHOR]

Published
2024
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45. Management of diabetic ketoacidosis in children: Does early insulin glargine help improve outcomes?

Author

Ohman‐Hanson, Rebecca, Alonso, G. Todd, Pyle, Laura, McDonough, Ryan, and Clements, Mark

Subjects
INSULIN derivatives, TYPE 1 diabetes, DIABETIC acidosis, INSULIN therapy, HYPOGLYCEMIA
Abstract

Background: Rebound hyperglycemia following the resolution of diabetic ketoacidosis (DKA) is common in pediatric patients with type 1 diabetes, increasing the risk of recurrent DKA and complicating the transition to subcutaneous insulin. Multiple studies suggest that early administration of long‐acting insulin analogs during DKA management safely improves this transition. Objective: This study aimed to determine whether early insulin glargine administration in children with DKA prevents rebound hyperglycemia and recurrent ketosis without increasing the rate of hypoglycemia or hypokalemia. Methods: Patients aged <21 years presenting with DKA to Children's Mercy Kansas City between October 2012 and October 2016 were reviewed. They were categorized as Early (>4 h of overlap with intravenous [IV] insulin) and Late (<2 h of overlap) cohorts. Results: We reviewed 546 DKA admissions (365 Early and 181 Late). Rebound hyperglycemia (>180 mg/dL) was lower in the Early group (66% vs. 85%, p ≤ 0.0001). Hypoglycemia (<70 mg/dL) during IV insulin administration was higher in the Early group than in the Late group (27% vs. 19%, p = 0.042). Hypoglycemia within 12 h of IV insulin discontinuation was lower in the Early group (16% vs. 26%, p = 0.012). Recurrent ketosis, hypokalemia, and cerebral edema were not different between the groups. Conclusions: Early glargine administration in pediatric DKA management is safe, decreases the rate of rebound hyperglycemia, and improves the transition to subcutaneous insulin. Hypoglycemia is less frequent following IV insulin discontinuation with early glargine, but the IV insulin rate may need to be reduced to minimize hypoglycemia during IV insulin infusion. [ABSTRACT FROM AUTHOR]

Published
2024
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49. The origin and speciation of orchids

Author

Pérez‐Escobar, Oscar A., primary, Bogarín, Diego, additional, Przelomska, Natalia A. S., additional, Ackerman, James D., additional, Balbuena, Juan A., additional, Bellot, Sidonie, additional, Bühlmann, Roland P., additional, Cabrera, Betsaida, additional, Cano, Jose Aguilar, additional, Charitonidou, Martha, additional, Chomicki, Guillaume, additional, Clements, Mark A., additional, Cribb, Phillip, additional, Fernández, Melania, additional, Flanagan, Nicola S., additional, Gravendeel, Barbara, additional, Hágsater, Eric, additional, Halley, John M., additional, Hu, Ai‐Qun, additional, Jaramillo, Carlos, additional, Mauad, Anna Victoria, additional, Maurin, Olivier, additional, Müntz, Robert, additional, Leitch, Ilia J., additional, Li, Lan, additional, Negrão, Raquel, additional, Oses, Lizbeth, additional, Phillips, Charlotte, additional, Rincon, Milton, additional, Salazar, Gerardo A., additional, Simpson, Lalita, additional, Smidt, Eric, additional, Solano‐Gomez, Rodolfo, additional, Parra‐Sánchez, Edicson, additional, Tremblay, Raymond L., additional, van den Berg, Cassio, additional, Tamayo, Boris Stefan Villanueva, additional, Zuluaga, Alejandro, additional, Zuntini, Alexandre R., additional, Chase, Mark W., additional, Fay, Michael F., additional, Condamine, Fabien L., additional, Forest, Felix, additional, Nargar, Katharina, additional, Renner, Susanne S., additional, Baker, William J., additional, and Antonelli, Alexandre, additional

Published
2024
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