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2. Impact of vaccination on the association of COVID-19 with cardiovascular diseases: An OpenSAFELY cohort study

Author

Cezard, Genevieve I., Denholm, Rachel E., Knight, Rochelle, Wei, Yinghui, Teece, Lucy, Toms, Renin, Forbes, Harriet J., Walker, Alex J., Fisher, Louis, Massey, Jon, Hopcroft, Lisa E. M., Horne, Elsie M. F., Taylor, Kurt, Palmer, Tom, Arab, Marwa Al, Cuitun Coronado, Jose Ignacio, Ip, Samantha H. Y., Davy, Simon, Dillingham, Iain, Bacon, Sebastian, Mehrkar, Amir, Morton, Caroline E., Greaves, Felix, Hyams, Catherine, Davey Smith, George, Macleod, John, Chaturvedi, Nishi, Goldacre, Ben, Whiteley, William N., Wood, Angela M., Sterne, Jonathan A. C., and Walker, Venexia

Published
2024
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3. Sodium–glucose co-transporter-2 inhibitors for hospitalised patients with COVID-19: a prospective meta-analysis of randomised trials

Author

Vale, Claire, Godolphin, Peter J, Fisher, David, Horby, Peter W, Kosiborod, Mikhail N, Hochman, Judith S, Webster, Katie, Higgins, Julian P T, Althouse, Andrew D, Berwanger, Otavio, Furtado, Remo H M, Gasparyan, Samvel B, Haynes, Richard, Koch, Gary G, Landray, Martin, Leifer, Eric, Marshall, John, Murthy, Srinivas, Neal, Matthew D, Staplin, Natalie, Diaz, Janet, Sterne, Jonathan A C, and Shankar-Hari, Manu

Published
2024
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4. Incidence of diabetes after SARS-CoV-2 infection in England and the implications of COVID-19 vaccination: a retrospective cohort study of 16 million people

Author

Al Arab, Marwa, Almaghrabi, Fatima, Andrews, Colm, Badrick, Ellena, Baz, Sarah, Beckford, Chelsea, Berman, Samantha, Bolton, Tom, Booth, Charlotte, Bowyer, Ruth, Boyd, Andy, Bridger-Staatz, Charis, Brophy, Sinead, Campbell, Archie, Campbell, Kirsteen C, Carnemolla, Alisia, Carpentieri, Jd, Cezard, Genevieve, Chaturvedi, Nishi, Cheetham, Nathan, Costello, Ruth, Cowling, Thomas, Crane, Matthew, Cuitun Coronado, Jose Ignacio, Curtis, Helen, Denaxas, Spiros, Denholm, Rachel, Di Gessa, Giorgio, Dobson, Richard, Douglas, Ian, Evans, Katharine M, Fang, Chao, Ferreira, Vanessa, Finnigan, Lucy, Fisher, Louis, Flaig, Robin, Folarin, Amos, Forbes, Harriet, Foster, Diane, Fox, Laura, Freydin, Maxim, Garcia, Paz, Gibson, Andy, Glen, Fiona, Goldacre, Ben, Goncalves Soares, Ana, Greaves, Felix, Green, Amelia, Green, Mark, Green, Michael, Griffith, Gareth, Hamill Howes, Lee, Hamilton, Olivia, Herbet, Annie, Herrett, Emily, Hopcroft, Lisa, Horne, Elsie, Hou, Bo, Hughes, Alun, Hulme, William, Huntley, Lizzie, Ip, Samantha, Jacques, Wels, Jezzard, Peter, Jones, Louise, Kanagaratnam, Arun, Karthikeyan Suseeladevi, Arun, Katikireddi, Vittal, Kellas, John, Kennedy, Jonathan I, Kibble, Milla, Knight, Rochelle, Knueppel, Anika, Kopasker, Daniel, Kromydas, Theocharis, Kwong, Alex, Langan, Sinead, Lemanska, Agnieszka, Lukaschuk, Elena, Mackenna, Brain, Macleod, John, Maddock, Jane, Mahalingasivam, Viyaasan, Mansfield, Kathryn, McArdle, Fintan, McCartney, Daniel, McEachan, Rosie, McElroy, Eoin, McLachlan, Stela, Mitchell, Ruth, Moltrecht, Bettina, Morley, Jess, Nab, Linda, Neubauer, Stefan, Nigrelli, Lidia, North, Teri, Northstone, Kate, Oakley, Jacqui, Palmer, Tom, Park, Chloe, Parker, Michael, Parsons, Sam, Patalay, Praveetha, Patel, Kishan, Perez-Reche, Francisco, Piechnik, Stefan, Piehlmaier, Dominik, Ploubidis, George, Rafeti, Elena, Raman, Betty, Ranjan, Yatharth, Rapala, Alicja, Rhead, Rebecca, Roberts, Amy, Sampri, Alexia, Sanders, Zeena-Britt, Santorelli, Gillian, Saunders, Laura C, Shah, Anoop, Shah, Syed Ahmar, Sharp, Steve, Shaw, Richard, Sheard, Laura, Sheikh, Aziz, Silverwood, Richard, Smeeth, Liam, Smith, Stephen, Stafford, Jean, Steptoe, Andrew, Sterne, Jonathan, Steves, Claire, Stewart, Callum, Taylor, Kurt, Tazare, John, Teece, Lucy, Thomas, Richard, Thompson, Ellen, Tilling, Kate, Timpson, Nicholas, Tomlinson, Laurie, Toms, Renin, Tunnicliffe, Elizabeth, Turner, Emma L, Walker, Alex, Walker, Venexia, Walter, Scott, Wang, Kevin, Wei, Yinghui, Whitehorn, Rebecca, Wielgoszewska, Bozena, Wild, James M, Willan, Kathryn, Willans, Robert, Williams, Dylan, Wong, Andrew, Wood, Angela, Woodward, Hannah, Wright, John, Yang, Tiffany, Zaninotto, Paola, Zheng, Bang, Zhu, Jingmin, Eastwood, Sophie, Horne, Elsie M F, Massey, Jon, Hopcroft, Lisa E M, Cuitun Coronado, Jose, Davy, Simon, Dillingham, Iain, Morton, Caroline, and Sterne, Jonathan A C

Published
2024
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5. Longitudinal trends in causes of death among adults with HIV on antiretroviral therapy in Europe and North America from 1996 to 2020: a collaboration of cohort studies

Author

Trickey, Adam, McGinnis, Kathleen, Gill, M John, Abgrall, Sophie, Berenguer, Juan, Wyen, Christoph, Hessamfar, Mojgan, Reiss, Peter, Kusejko, Katharina, Silverberg, Michael J, Imaz, Arkaitz, Teira, Ramon, d'Arminio Monforte, Antonella, Zangerle, Robert, Guest, Jodie L, Papastamopoulos, Vasileios, Crane, Heidi, Sterling, Timothy R, Grabar, Sophie, Ingle, Suzanne M, and Sterne, Jonathan A C

Published
2024
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6. Integrase strand-transfer inhibitor use and cardiovascular events in adults with HIV: an emulation of target trials in the HIV-CAUSAL Collaboration and the Antiretroviral Therapy Cohort Collaboration

Author

Rein, Sophia M, Lodi, Sara, Logan, Roger W, Touloumi, Giota, Antoniadou, Anastasia, Wittkop, Linda, Bonnet, Fabrice, van Sighem, Ard, van der Valk, Marc, Reiss, Peter, Klein, Marina B, Young, James, Jarrin, Inmaculada, d'Arminio Monforte, Antonella, Tavelli, Alessandro, Meyer, Laurence, Tran, Laurent, Gill, Michael J, Lang, Raynell, Surial, Bernard, Haas, Andreas D, Justice, Amy C, Rentsch, Christopher T, Phillips, Andrew, Sabin, Caroline A, Miro, Jose M, Trickey, Adam, Ingle, Suzanne M, Sterne, Jonathan A C, and Hernán, Miguel A

Published
2023
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7. HIV-1 drug resistance in people on dolutegravir-based antiretroviral therapy: a collaborative cohort analysis

Author

Loosli, Tom, Hossmann, Stefanie, Ingle, Suzanne M, Okhai, Hajra, Kusejko, Katharina, Mouton, Johannes, Bellecave, Pantxika, van Sighem, Ard, Stecher, Melanie, d'Arminio Monforte, Antonella, Gill, M John, Sabin, Caroline A, Maartens, Gary, Günthard, Huldrych F, Sterne, Jonathan A C, Lessells, Richard, Egger, Matthias, and Kouyos, Roger D

Published
2023
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8. All-cause hospitalisation among people living with HIV according to gender, mode of HIV acquisition, ethnicity, and geographical origin in Europe and North America: findings from the ART-CC cohort collaboration

Author

Rein, Sophia M, Lampe, Fiona C, Ingle, Suzanne M, Sterne, Jonathan A C, Trickey, Adam, Gill, M John, Papastamopoulos, Vasileios, Wittkop, Linda, van der Valk, Marc, Kitchen, Maria, Guest, Jodie L, Satre, Derek D, Wandeler, Gilles, Galindo, Pepa, Castilho, Jessica, Crane, Heidi M, and Smith, Colette J

Published
2023
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10. The impact of the COVID-19 pandemic on cardiovascular disease prevention and management

Author

Dale, Caroline E., Takhar, Rohan, Carragher, Raymond, Katsoulis, Michail, Torabi, Fatemeh, Duffield, Stephen, Kent, Seamus, Mueller, Tanja, Kurdi, Amanj, Le Anh, Thu Nguyen, McTaggart, Stuart, Abbasizanjani, Hoda, Hollings, Sam, Scourfield, Andrew, Lyons, Ronan A., Griffiths, Rowena, Lyons, Jane, Davies, Gareth, Harris, Daniel, Handy, Alex, Mizani, Mehrdad A., Tomlinson, Christopher, Thygesen, Johan H., Ashworth, Mark, Denaxas, Spiros, Banerjee, Amitava, Sterne, Jonathan A. C., Brown, Paul, Bullard, Ian, Priedon, Rouven, Mamas, Mamas A., Slee, Ann, Lorgelly, Paula, Pirmohamed, Munir, Khunti, Kamlesh, Morris, Andrew D., Sudlow, Cathie, Akbari, Ashley, Bennie, Marion, Sattar, Naveed, and Sofat, Reecha

Published
2023
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11. Life expectancy after 2015 of adults with HIV on long-term antiretroviral therapy in Europe and North America: a collaborative analysis of cohort studies

Author

Trickey, Adam, Sabin, Caroline A, Burkholder, Greer, Crane, Heidi, d'Arminio Monforte, Antonella, Egger, Matthias, Gill, M John, Grabar, Sophie, Guest, Jodie L, Jarrin, Inma, Lampe, Fiona C, Obel, Niels, Reyes, Juliana M, Stephan, Christoph, Sterling, Timothy R, Teira, Ramon, Touloumi, Giota, Wasmuth, Jan-Christian, Wit, Ferdinand, Wittkop, Linda, Zangerle, Robert, Silverberg, Michael J, Justice, Amy, and Sterne, Jonathan A C

Published
2023
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12. Investigating and Dealing with Publication Bias and Other Reporting Biases in Meta-Analyses of Health Research: A Review

Author

Page, Matthew J., Sterne, Jonathan A. C., Higgins, Julian P. T., and Egger, Matthias

Abstract

A "P" value, or the magnitude or direction of results can influence decisions about whether, when, and how research findings are disseminated. Regardless of whether an entire study or a particular study result is unavailable because investigators considered the results to be unfavorable, bias in a meta-analysis may occur when available results differ systematically from missing results. In this article, we summarize the empirical evidence for various reporting biases that lead to study results being unavailable for inclusion in systematic reviews, with a focus on health research. These biases include publication bias and selective nonreporting bias. We describe processes that systematic reviewers can use to minimize the risk of bias due to missing results in meta-analyses of health research, such as comprehensive searches and prospective approaches to meta-analysis. We also outline methods that have been designed for assessing risk of bias due to missing results in meta-analyses of health research, including using tools to assess selective nonreporting of results, ascertaining qualitative signals that suggest not all studies were identified, and generating funnel plots to identify small-study effects, one cause of which is reporting bias.

Published
2021
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13. COVID-19 trajectories among 57 million adults in England: a cohort study using electronic health records

Author

Abbasizanjani, Hoda, Ahmed, Nida, Ahmed, Badar, Akbari, Ashley, Akinoso-Imran, Abdul Qadr, Allara, Elias, Allery, Freya, Angelantonio, Emanuele Di, Ashworth, Mark, Ayyar-Gupta, Vandana, Babu-Narayan, Sonya, Bacon, Seb, Ball, Steve, Banerjee, Ami, Barber, Mark, Barrett, Jessica, Bennie, Marion, Berry, Colin, Beveridge, Jennifer, Birney, Ewan, Bojanić, Lana, Bolton, Thomas, Bone, Anna, Boyle, Jon, Braithwaite, Tasanee, Bray, Ben, Briffa, Norman, Brind, David, Brown, Katherine, Buch, Maya, Canoy, Dexter, Caputo, Massimo, Carragher, Raymond, Carson, Alan, Cezard, Genevieve, Chang, Jen-Yu Amy, Cheema, Kate, Chin, Richard, Chudasama, Yogini, Cooper, Jennifer, Copland, Emma, Crallan, Rebecca, Cripps, Rachel, Cromwell, David, Curcin, Vasa, Curry, Gwenetta, Dale, Caroline, Danesh, John, Das-Munshi, Jayati, Dashtban, Ashkan, Davies, Alun, Davies, Joanna, Davies, Gareth, Davies, Neil, Day, Joshua, Delmestri, Antonella, Denaxas, Spiros, Denholm, Rachel, Dennis, John, Denniston, Alastair, Deo, Salil, Dhillon, Baljean, Docherty, Annemarie, Dong, Tim, Douiri, Abdel, Downs, Johnny, Dregan, Alexandru, Ellins, Elizabeth A, Elwenspoek, Martha, Falck, Fabian, Falter, Florian, Fan, Yat Yi, Firth, Joseph, Fraser, Lorna, Friebel, Rocco, Gavrieli, Amir, Gerstung, Moritz, Gilbert, Ruth, Gillies, Clare, Glickman, Myer, Goldacre, Ben, Goldacre, Raph, Greaves, Felix, Green, Mark, Grieco, Luca, Griffiths, Rowena, Gurdasani, Deepti, Halcox, Julian, Hall, Nick, Hama, Tuankasfee, Handy, Alex, Hansell, Anna, Hardelid, Pia, Hardy, Flavien, Harris, Daniel, Harrison, Camille, Harron, Katie, Hassaine, Abdelaali, Hassan, Lamiece, Healey, Russell, Hemingway, Harry, Henderson, Angela, Herz, Naomi, Heyl, Johannes, Hidajat, Mira, Higginson, Irene, Hinchliffe, Rosie, Hippisley-Cox, Julia, Ho, Frederick, Hocaoglu, Mevhibe, Hollings, Sam, Horne, Elsie, Hughes, David, Humberstone, Ben, Inouye, Mike, Ip, Samantha, Islam, Nazrul, Jackson, Caroline, Jenkins, David, Jiang, Xiyun, Johnson, Shane, Kadam, Umesh, Kallis, Costas, Karim, Zainab, Kasan, Jake, Katsoulis, Michalis, Kavanagh, Kim, Kee, Frank, Keene, Spencer, Kent, Seamus, Khalid, Sara, Khawaja, Anthony, Khunti, Kamlesh, Killick, Richard, Kinnear, Deborah, Knight, Rochelle, Kolamunnage-Dona, Ruwanthi, Kontopantelis, Evan, Kurdi, Amanj, Lacey, Ben, Lai, Alvina, Lambarth, Andrew, Larzjan, Milad Nazarzadeh, Lawler, Deborah, Lawrence, Thomas, Lawson, Claire, Li, Qiuju, Li, Ken, Llinares, Miguel Bernabeu, Lorgelly, Paula, Lowe, Deborah, Lyons, Jane, Lyons, Ronan, Machado, Pedro, Macleod, Mary Joan, Macleod, John, Malgapo, Evaleen, Mamas, Mamas, Mamouei, Mohammad, Manohar, Sinduja, Mapeta, Rutendo, Martelli, Javiera Leniz, Martos, David Moreno, Mateen, Bilal, McCarthy, Aoife, Melville, Craig, Milton, Rebecca, Mizani, Mehrdad, Moncusi, Marta Pineda, Morales, Daniel, Mordi, Ify, Morrice, Lynn, Morris, Carole, Morris, Eva, Mu, Yi, Mueller, Tanja, Murdock, Lars, Nafilyan, Vahé, Nicholson, George, Nikiphorou, Elena, Nolan, John, Norris, Tom, Norris, Ruth, North, Laura, North, Teri-Louise, O'Connell, Dan, Oliver, Dominic, Oluyase, Adejoke, Olvera-Barrios, Abraham, Omigie, Efosa, Onida, Sarah, Padmanabhan, Sandosh, Palmer, Tom, Pasea, Laura, Patel, Riyaz, Payne, Rupert, Pell, Jill, Petitjean, Carmen, Pherwani, Arun, Pickrell, Owen, Pierotti, Livia, Pirmohamed, Munir, Priedon, Rouven, Prieto-Alhambra, Dani, Proudfoot, Alastair, Quinn, Terry, Quint, Jennifer, Raffetti, Elena, Rahimi, Kazem, Rao, Shishir, Razieh, Cameron, Roberts, Brian, Rogers, Caroline, Rossdale, Jennifer, Salim, Safa, Samani, Nilesh, Sattar, Naveed, Schnier, Christian, Schwartz, Roy, Selby, David, Seminog, Olena, Shabnam, Sharmin, Shah, Ajay, Shelton, Jon, Sheppard, James, Sinha, Shubhra, Skrypak, Mirek, Slapkova, Martina, Sleeman, Katherine, Smith, Craig, Sofat, Reecha, Sosenko, Filip, Sperrin, Matthew, Steeg, Sarah, Sterne, Jonathan, Stoica, Serban, Sudell, Maria, Sudlow, Cathie, Sun, Luanluan, Suseeladevi, Arun Karthikeyan, Sweeting, Michael, Sydes, Matt, Takhar, Rohan, Tang, Howard, Thygesen, Johan, Tilston, George, Tochel, Claire, Toit, Clea du, Tomlinson, Christopher, Toms, Renin, Torabi, Fatemeh, Torralbo, Ana, Townson, Julia, Tufail, Adnan, Tungamirai, Tapiwa, Varma, Susheel, Vollmer, Sebastian, Walker, Venexia, Wang, Tianxiao, Wang, Huan, Warwick, Alasdair, Watkinson, Ruth, Watson, Harry, Whiteley, William, Whittaker, Hannah, Wilde, Harry, Wilkinson, Tim, Williams, Gareth, Williams, Michelle, Williams, Richard, Withnell, Eloise, Wolfe, Charles, Wood, Angela, Wright, Lucy, Wu, Honghan, Wu, Jinge, Wu, Jianhua, Yates, Tom, Zaccardi, Francesco, Zhang, Haoting, Zhang, Huayu, Zuccolo, Luisa, Thygesen, Johan H, Mizani, Mehrdad A, Banerjee, Amitava, Lai, Alvina G, Li, Kezhi, Mateen, Bilal A, Sterne, Jonathan A C, Pagel, Christina, and Whiteley, William N

Published
2022
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14. Associations of modern initial antiretroviral drug regimens with all-cause mortality in adults with HIV in Europe and North America: a cohort study

Author

Trickey, Adam, Zhang, Lei, Gill, M John, Bonnet, Fabrice, Burkholder, Greer, Castagna, Antonella, Cavassini, Matthias, Cichon, Piotr, Crane, Heidi, Domingo, Pere, Grabar, Sophie, Guest, Jodie, Obel, Niels, Psichogiou, Mina, Rava, Marta, Reiss, Peter, Rentsch, Christopher T, Riera, Melchor, Schuettfort, Gundolf, Silverberg, Michael J, Smith, Colette, Stecher, Melanie, Sterling, Timothy R, Ingle, Suzanne M, Sabin, Caroline A, and Sterne, Jonathan A C

Published
2022
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15. The Median and the Mode as Robust Meta-Analysis Estimators in the Presence of Small-Study Effects and Outliers

Author

Hartwig, Fernando P., Davey Smith, George, Schmidt, Amand F., Sterne, Jonathan A. C., Higgins, Julian P. T., and Bowden, Jack

Abstract

Meta-analyses based on systematic literature reviews are commonly used to obtain a quantitative summary of the available evidence on a given topic. However, the reliability of any meta-analysis is constrained by that of its constituent studies. One major limitation is the possibility of small-study effects, when estimates from smaller and larger studies differ systematically. Small-study effects may result from reporting biases (ie, publication bias), from inadequacies of the included studies that are related to study size, or from reasons unrelated to bias. We propose two estimators based on the median and mode to increase the reliability of findings in a meta-analysis by mitigating the influence of small-study effects. By re-examining data from published meta-analyses and by conducting a simulation study, we show that these estimators offer robustness to a range of plausible bias mechanisms, without making explicit modelling assumptions. They are also robust to outlying studies without explicitly removing such studies from the analysis. When meta-analyses are suspected to be at risk of bias because of small-study effects, we recommend reporting the mean, median and modal pooled estimates.

Published
2020
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16. Considerations in boosting COVID-19 vaccine immune responses

Author

Krause, Philip R, Fleming, Thomas R, Peto, Richard, Longini, Ira M, Figueroa, J Peter, Sterne, Jonathan A C, Cravioto, Alejandro, Rees, Helen, Higgins, Julian P T, Boutron, Isabelle, Pan, Hongchao, Gruber, Marion F, Arora, Narendra, Kazi, Fatema, Gaspar, Rogerio, Swaminathan, Soumya, Ryan, Michael J, and Henao-Restrepo, Ana-Maria

Published
2021
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18. Effectiveness of mRNA COVID-19 Vaccines as First Booster Doses in England: An Observational Study in OpenSAFELY-TPP.

Author

Horne, Elsie M. F., Hulme, William J., Parker, Edward P. K., Keogh, Ruth H., Williamson, Elizabeth J., Walker, Venexia M., Palmer, Tom M., Denholm, Rachel, Knight, Rochelle, Curtis, Helen J., Walker, Alex J., Andrews, Colm D., Mehrkar, Amir, Morley, Jessica, MacKenna, Brian, Bacon, Sebastian C. J., Goldacre, Ben, Hernán, Miguel A., and Sterne, Jonathan A. C.

Abstract

Background: The UK delivered its first “booster” COVID-19 vaccine doses in September 2021, initially to individuals at high risk of severe disease, then to all adults. The BNT162b2 Pfizer-BioNTech vaccine was used initially, then also Moderna mRNA-1273. Methods: With the approval of the National Health Service England, we used routine clinical data to estimate the effectiveness of boosting with BNT162b2 or mRNA-1273 compared with no boosting in eligible adults who had received two primary course vaccine doses. We matched each booster recipient with an unboosted control on factors relating to booster priority status and prior COVID-19 immunization. We adjusted for additional factors in Cox models, estimating hazard ratios up to 182 days (6 months) following booster dose. We estimated hazard ratios overall and within the following periods: 1–14, 15–42, 43–69, 70–97, 98–126, 127–152, and 155–182 days. Outcomes included a positive SARS-CoV-2 test, COVID-19 hospitalization, COVID-19 death, non-COVID-19 death, and fracture. Results: We matched 8,198,643 booster recipients with unboosted controls. Adjusted hazard ratios over 6-month follow-up were: positive SARS-CoV-2 test 0.75 (0.74, 0.75); COVID-19 hospitalization 0.30 (0.29, 0.31); COVID-19 death 0.11 (0.10, 0.14); non- COVID-19 death 0.22 (0.21, 0.23); and fracture 0.77 (0.75, 0.78). Estimated effectiveness of booster vaccines against severe COVID- 19-related outcomes peaked during the first 3 months following the booster dose. By 6 months, the cumulative incidence of positive SARS-CoV-2 test was higher in boosted than unboosted individuals. Conclusions: We estimate that COVID-19 booster vaccination, compared with no booster vaccination, provided substantial protection against COVID-19 hospitalization and COVID-19 death but only limited protection against positive SARS-CoV-2 test. Lower rates of fracture in boosted than unboosted individuals may suggest unmeasured confounding. Observational studies should report estimated vaccine effectiveness against nontarget and negative control outcomes. [ABSTRACT FROM AUTHOR]

Published
2024
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20. RoB 2 : a revised tool for assessing risk of bias in randomised trials

Author

Sterne, Jonathan A C, Savović, Jelena, Page, Matthew J, Elbers, Roy G, Blencowe, Natalie S, Boutron, Isabelle, Cates, Christopher J, Cheng, Hung-Yuan, Corbett, Mark S, Eldridge, Sandra M, Emberson, Jonathan R, Hernán, Miguel A, Hopewell, Sally, Hróbjartsson, Asbjorn, Junqueira, Daniela R, Jüni, Peter, Kirkham, Jamie J, Lasserson, Toby, Li, Tianjing, McAleenan, Alexandra, Reeves, Barnaby C, Shepperd, Sasha, Shrier, Ian, Stewart, Lesley A, Tilling, Kate, White, Ian R, Whiting, Penny F, and Higgins, Julian P T

Published
2019

21. Prostate-Specific Antigen Screening and 15-Year Prostate Cancer Mortality: A Secondary Analysis of the CAP Randomized Clinical Trial.

Author

Martin, Richard M., Turner, Emma L., Young, Grace J., Metcalfe, Chris, Walsh, Eleanor I., Lane, J. Athene, Sterne, Jonathan A. C., Noble, Sian, Holding, Peter, Ben-Shlomo, Yoav, Williams, Naomi J., Pashayan, Nora, Bui, Mai Ngoc, Albertsen, Peter C., Seibert, Tyler M., Zietman, Anthony L., Oxley, Jon, Adolfsson, Jan, Mason, Malcolm D., and Davey Smith, George

Abstract

This secondary analysis of a randomized clinical trial assesses whether screening for prostate-specific antigen reduces prostate cancer mortality at 15-year follow-up. Key Points: Question: In men aged 50 to 69 years, does a single invitation for a prostate-specific antigen (PSA) screening test reduce prostate cancer mortality at 15-year follow-up compared with no invitation for testing? Findings: In this secondary analysis of a randomized clinical trial of 415 357 men aged 50 to 69 years randomized to a single invitation for PSA screening (n = 195 912) or a control group without PSA screening (n = 219 445) and followed up for a median of 15 years, risk of death from prostate cancer was lower in the group invited to screening (0.69% vs 0.78%; mean difference, 0.09%) compared with the control group. Meaning: Compared with no invitation for routine PSA testing, a single invitation for a PSA screening test reduced prostate cancer mortality at a median follow-up of 15 years, but the absolute mortality benefit was small. Importance: The Cluster Randomized Trial of PSA Testing for Prostate Cancer (CAP) reported no effect of prostate-specific antigen (PSA) screening on prostate cancer mortality at a median 10-year follow-up (primary outcome), but the long-term effects of PSA screening on prostate cancer mortality remain unclear. Objective: To evaluate the effect of a single invitation for PSA screening on prostate cancer–specific mortality at a median 15-year follow-up compared with no invitation for screening. Design, Setting, and Participants: This secondary analysis of the CAP randomized clinical trial included men aged 50 to 69 years identified at 573 primary care practices in England and Wales. Primary care practices were randomized between September 25, 2001, and August 24, 2007, and men were enrolled between January 8, 2002, and January 20, 2009. Follow-up was completed on March 31, 2021. Intervention: Men received a single invitation for a PSA screening test with subsequent diagnostic tests if the PSA level was 3.0 ng/mL or higher. The control group received standard practice (no invitation). Main Outcomes and Measures: The primary outcome was reported previously. Of 8 prespecified secondary outcomes, results of 4 were reported previously. The 4 remaining prespecified secondary outcomes at 15-year follow-up were prostate cancer–specific mortality, all-cause mortality, and prostate cancer stage and Gleason grade at diagnosis. Results: Of 415 357 eligible men (mean [SD] age, 59.0 [5.6] years), 98% were included in these analyses. Overall, 12 013 and 12 958 men with a prostate cancer diagnosis were in the intervention and control groups, respectively (15-year cumulative risk, 7.08% [95% CI, 6.95%-7.21%] and 6.94% [95% CI, 6.82%-7.06%], respectively). At a median 15-year follow-up, 1199 men in the intervention group (0.69% [95% CI, 0.65%-0.73%]) and 1451 men in the control group (0.78% [95% CI, 0.73%-0.82%]) died of prostate cancer (rate ratio [RR], 0.92 [95% CI, 0.85-0.99]; P =.03). Compared with the control, the PSA screening intervention increased detection of low-grade (Gleason score [GS] ≤6: 2.2% vs 1.6%; P <.001) and localized (T1/T2: 3.6% vs 3.1%; P <.001) disease but not intermediate (GS of 7), high-grade (GS ≥8), locally advanced (T3), or distally advanced (T4/N1/M1) tumors. There were 45 084 all-cause deaths in the intervention group (23.2% [95% CI, 23.0%-23.4%]) and 50 336 deaths in the control group (23.3% [95% CI, 23.1%-23.5%]) (RR, 0.97 [95% CI, 0.94-1.01]; P =.11). Eight of the prostate cancer deaths in the intervention group (0.7%) and 7 deaths in the control group (0.5%) were related to a diagnostic biopsy or prostate cancer treatment. Conclusions and Relevance: In this secondary analysis of a randomized clinical trial, a single invitation for PSA screening compared with standard practice without routine screening reduced prostate cancer deaths at a median follow-up of 15 years. However, the absolute reduction in deaths was small. Trial Registration: isrctn.org Identifier: ISRCTN92187251 [ABSTRACT FROM AUTHOR]

Published
2024
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22. Association of COVID-19 vaccines ChAdOx1 and BNT162b2 with major venous, arterial, or thrombocytopenic events: A population-based cohort study of 46 million adults in England

Author

Whiteley, William N., Ip, Samantha, Cooper, Jennifer A., Bolton, Thomas, Keene, Spencer, Walker, Venexia, Denholm, Rachel, Akbari, Ashley, Omigie, Efosa, Hollings, Sam, Di Angelantonio, Emanuele, Denaxas, Spiros, Wood, Angela, Sterne, Jonathan A. C., and Sudlow, Cathie

Subjects
Blood clot -- Risk factors -- Demographic aspects, Thrombosis -- Risk factors -- Demographic aspects, Thrombocytopenia -- Risk factors -- Demographic aspects, Biological sciences, Comirnaty (Vaccine) -- Complications and side effects, AZD1222 (Vaccine) -- Complications and side effects
Abstract

Background Thromboses in unusual locations after the Coronavirus Disease 2019 (COVID-19) vaccine ChAdOx1-S have been reported, although their frequency with vaccines of different types is uncertain at a population level. The aim of this study was to estimate the population-level risks of hospitalised thrombocytopenia and major arterial and venous thromboses after COVID-19 vaccination. Methods and findings In this whole-population cohort study, we analysed linked electronic health records from adults living in England, from 8 December 2020 to 18 March 2021. We estimated incidence rates and hazard ratios (HRs) for major arterial, venous, and thrombocytopenic outcomes 1 to 28 and >28 days after first vaccination dose for ChAdOx1-S and BNT162b2 vaccines. Analyses were performed separately for ages Of 46 million adults, 23 million (51%) were women; 39 million (84%) were 28 days post-ChAdOx1-S, 359 (338 to 382), [less than or equal to]28 days post-BNT162b2-S, 241 (229 to 253); >28 days post-BNT162b2-S 277 (263 to 291). The crude incidence rates (per 100,000 person-years) of all arterial events were as follows: prevaccination, 546 (95% CI: 541 to 555); [less than or equal to]28 days post-ChAdOx1-S, 1,211 (1,185 to 1,237); >28 days post-ChAdOx1-S, 1678 (1,630 to 1,726), [less than or equal to]28 days post-BNT162b2-S, 1,242 (1,214 to 1,269); >28 days post-BNT162b2-S, 1,539 (1,507 to 1,572). Adjusted HRs (aHRs) 1 to 28 days after ChAdOx1-S, compared with unvaccinated rates, at ages Rates of intracranial venous thrombosis (ICVT) and of thrombocytopenia in adults aged The main limitations of the study are as follows: (i) it relies on the accuracy of coded healthcare data to identify exposures, covariates, and outcomes; (ii) the use of primary reason for hospital admission to measure outcome, which improves the positive predictive value but may lead to an underestimation of incidence; and (iii) potential unmeasured confounding. Conclusions In this study, we observed increases in rates of ICVT and thrombocytopenia after ChAdOx1-S vaccination in adults aged, Author(s): William N. Whiteley 1,2,*, Samantha Ip 3, Jennifer A. Cooper 4, Thomas Bolton 3,5, Spencer Keene 3, Venexia Walker 4, Rachel Denholm 4, Ashley Akbari 6, Efosa Omigie 7, [...]

Published
2022
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23. CD4:CD8 Ratio and CD8 Count as Prognostic Markers for Mortality in Human Immunodeficiency Virus–Infected Patients on Antiretroviral Therapy: The Antiretroviral Therapy Cohort Collaboration (ART-CC)

Author

Antiretroviral Therapy Cohort Collaboration (ART-CC), Trickey, Adam, May, Margaret T., Schommers, Philipp, Tate, Jan, Ingle, Suzanne M., Guest, Jodie L., Gill, M. John, Zangerle, Robert, Saag, Mike, Reiss, Peter, Monforte, Antonella d'Arminio, Johnson, Margaret, Lima, Viviane D., Sterling, Tim R., Cavassini, Matthias, Wittkop, Linda, Costagliola, Dominique, and Sterne, Jonathan A. C.

Published
2017

25. Survival of HIV-positive patients starting antiretroviral therapy between 1996 and 2013: a collaborative analysis of cohort studies

Author

Trickey, Adam, May, Margaret T, Vehreschild, Jorg-Janne, Obel, Niels, Gill, M John, Crane, Heidi M, Boesecke, Christoph, Patterson, Sophie, Grabar, Sophie, Cazanave, Charles, Cavassini, Matthias, Shepherd, Leah, Monforte, Antonella d'Arminio, van Sighem, Ard, Saag, Mike, Lampe, Fiona, Hernando, Vicky, Montero, Marta, Zangerle, Robert, Justice, Amy C, Sterling, Timothy, Ingle, Suzanne M, and Sterne, Jonathan A C

Published
2017
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26. CHALLENGES IN ESTIMATING THE EFFECTIVENESS OF 2 DOSES OF COVID-19 VACCINE BEYOND 6 MONTHS IN ENGLAND.

Author

Horne, Elsie M F, Hulme, William J, Keogh, Ruth H, Palmer, Tom M, Williamson, Elizabeth J, Parker, Edward P K, Walker, Venexia M, Knight, Rochelle, Wei, Yinghui, Taylor, Kurt, Fisher, Louis, Morley, Jessica, Mehrkar, Amir, Dillingham, Iain, Bacon, Sebastian, Goldacre, Ben, Sterne, Jonathan A C, and Collaborative, for the OpenSAFELY

Subjects
COVID-19, IMMUNIZATION, CONFIDENCE intervals, COVID-19 vaccines, TIME, VACCINATION coverage, VACCINE effectiveness, DESCRIPTIVE statistics, HOSPITAL care, DEATH, EVALUATION
Abstract

The article discusses a study which examined the effectiveness of two doses of coronavirus disease 2019 (COVID-19) vaccine beyond six months in England. Topics include increase in the cumulative incidence of receiving a third dose of vaccine during the eight weeks following eligibility, basis of the effectiveness of two doses during later comparison periods, and important factors in interpreting estimated vaccine effectiveness (VE).

Published
2024
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28. Mortality According to CD4 Count at Start of Combination Antiretroviral Therapy Among HIV-infected Patients Followed for up to 15 Years After Start of Treatment: Collaborative Cohort Study

Author

Antiretroviral Therapy Cohort Collaboration (ART-CC), May, Margaret T., Vehreschild, Jorg-Janne, Trickey, Adam, Obel, Niels, Reiss, Peter, Bonnet, Fabrice, Mary-Krause, Murielle, Samji, Hasina, Cavassini, Matthias, Gill, Michael John, Shepherd, Leah C., Crane, Heidi M., Monforte, Antonella d'Arminio, Burkholder, Greer A., Johnson, Margaret M., Sobrino-Vegas, Paz, Domingo, Pere, Zangerle, Robert, Justice, Amy C., Sterling, Timothy R., Miró, José M., and Sterne, Jonathan A. C.

Published
2016

31. Comparative Effectiveness of Dynamic Treatment Strategies for Medication Use and Dosage: Emulating a Target Trial Using Observational Data.

Author

Birnie, Kate, Tomson, Charles, Caskey, Fergus J., Ben-Shlomo, Yoav, Nitsch, Dorothea, Casula, Anna, Murray, Eleanor J., and Sterne, Jonathan A. C.

Abstract

Background: Availability of detailed data from electronic health records (EHRs) has increased the potential to examine the comparative effectiveness of dynamic treatment strategies using observational data. Inverse probability (IP) weighting of dynamic marginal structural models can control for time-varying confounders. However, IP weights for continuous treatments may be sensitive to model choice. Methods: We describe a target trial comparing strategies for treating anemia with darbepoetin in hemodialysis patients using EHR data from the UK Renal Registry 2004 to 2016. Patients received a specified dose (microgram/week) or did not receive darbepoetin. We compared 4 methods for modeling time-varying treatment: (A) logistic regression for zero dose, standard linear regression for log dose; (B) logistic regression for zero dose, heteroscedastic linear regression for log dose; (C) logistic regression for zero dose, heteroscedastic linear regression for log dose, multinomial regression for patients who recently received very low or high doses; and (D) ordinal logistic regression. Results: For this dataset, method (C) was the only approach that provided a robust estimate of the mortality hazard ratio (HR), with less-extreme weights in a fully weighted analysis and no substantial change of the HR point estimate after weight truncation. After truncating IP weights at the 95th percentile, estimates were similar across the methods. Conclusions: EHR data can be used to emulate target trials estimating the comparative effectiveness of dynamic strategies adjusting treatment to evolving patient characteristics. However, model checking, monitoring of large weights, and adaptation of model strategies to account for these is essential if an aspect of treatment is continuous. [ABSTRACT FROM AUTHOR]

Published
2023
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32. Effect of a Low-Intensity PSA-Based Screening Intervention on Prostate Cancer Mortality: The CAP Randomized Clinical Trial

Author

Martin, Richard M., Donovan, Jenny L., Turner, Emma L., Metcalfe, Chris, Young, Grace J., Walsh, Eleanor I., Lane, J. Athene, Noble, Sian, Oliver, Steven E., Evans, Simon, Sterne, Jonathan A. C., Holding, Peter, Ben-Shlomo, Yoav, Brindle, Peter, Williams, Naomi J., Hill, Elizabeth M., Ng, Siaw Yein, Toole, Jessica, Tazewell, Marta K., Hughes, Laura J., Davies, Charlotte F., Thorn, Joanna C., Down, Elizabeth, Davey Smith, George, Neal, David E., and Hamdy, Freddie C.

Published
2018
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34. Impact of Risk Factors for Specific Causes of Death in the First and Subsequent Years of Antiretroviral Therapy Among HIV-Infected Patients

Author

Antiretroviral Therapy Cohort Collaboration, Ingle, Suzanne M., May, Margaret T., Gill, M. John, Mugavero, Michael J., Lewden, Charlotte, Abgrall, Sophie, Fätkenheuer, Gerd, Reiss, Peter, Saag, Michael S., Manzardo, Christian, Grabar, Sophie, Bruyand, Mathias, Moore, David, Mocroft, Amanda, Sterling, Timothy R., D'Arminio Monforte, Antonella, Hernando, Victoria, Teira, Ramon, Guest, Jodie, Cavassini, Matthias, Crane, Heidi M., and Sterne, Jonathan A. C.

Published
2014
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35. Oral anticoagulants for prevention of stroke in atrial fibrillation: systematic review, network meta-analysis, and cost effectiveness analysis

Author

López-López, José A, Sterne, Jonathan A C, Thom, Howard H Z, Higgins, Julian P T, Hingorani, Aroon D, Okoli, George N, Davies, Philippa A, Bodalia, Pritesh N, Bryden, Peter A, Welton, Nicky J, Hollingworth, William, Caldwell, Deborah M, Savović, Jelena, Dias, Sofia, Salisbury, Chris, Eaton, Diane, Stephens-Boal, Annya, and Sofat, Reecha

Published
2017
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37. Comparative effectiveness of BNT162b2 versus mRNA-1273 covid-19 vaccine boosting in England: matched cohort study in OpenSAFELY-TPP.

Author

Hulme, William J., Horne, Elsie M. F., Parker, Edward P. K., Keogh, Ruth H., Williamson, Elizabeth J., Walker, Venexia, Palmer, Tom M., Curtis, Helen J., Walker, Alex J., Andrews, Colm D., Mehrkar, Amir, Morley, Jessica, MacKenna, Brian, Bacon, Sebastian C. J., Goldacre, Ben, Hernán, Miguel A., and Sterne, Jonathan A. C.

Subjects
IMMUNIZATION, COVID-19, CONFIDENCE intervals, COVID-19 vaccines, CASE-control method, PATIENTS, VACCINE effectiveness, HOSPITAL admission & discharge, MESSENGER RNA, DESCRIPTIVE statistics, PATIENT safety, LONGITUDINAL method
Published
2023
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49. Coverage And Uptake Of Systematic Postal Screening For Genital Chlamydia Trachomatis And Prevalence Of Infection In The United Kingdom General Population: Cross Sectional Study

Author

Macleod, John, Salisbury, Chris, Low, Nicola, McCarthy, Anne, Sterne, Jonathan A. C., Holloway, Aisha, Patel, Rita, Sanford, Emma, Morcom, Andrea, Horner, Paddy, Smith, George Davey, Skidmore, Susan, Herring, Alan, Caul, Owen, Hobbs, F. D. Richard, and Egger, Matthias

Published
2005
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