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3. Evaluation of interventions to prevent vasovagal reactions among whole blood donors: rationale and design of a large cluster randomised trial

Author

McMahon, Amy, Kaptoge, Stephen, Walker, Matthew, Mehenny, Susan, Gilchrist, Philippe T, Sambrook, Jennifer, Akhtar, Naim, Sweeting, Michael, Wood, Angela M, Stirrups, Kathleen, Chung, Ryan, Fahle, Sarah, Johnson, Elisha, Cullen, Donna, Godfrey, Rosemary, Duthie, Shannon, Allen, Louise, Harvey, Paul, Berkson, Michael, Allen, Elizabeth, Watkins, Nicholas A, Bradley, John R, Kingston, Nathalie, Miflin, Gail, Armitage, Jane, Roberts, David J, Danesh, John, and Di Angelantonio, Emanuele

Published
2023
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4. 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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6. Treatment Effect Measures Under Nonproportional Hazards.

Author

Jackson, Dan, Sweeting, Michael, and Baker, Rose

Subjects
*SURVIVAL analysis (Biometry), *TREATMENT effectiveness, *HAZARDS, *MOTIVATION (Psychology), *STATISTICS
Abstract

ABSTRACT ‘Treatment effect measures under nonproportional hazards’ by Snapinn et al. (Pharmaceutical Statistics, 22, 181–193) recently proposed some novel estimates of treatment effect for time‐to‐event endpoints. In this note, we clarify three points related to the proposed estimators that help to elucidate their properties. We hope that their work, and this commentary, will motivate further discussion concerning treatment effect measures that do not require the proportional hazards assumption. [ABSTRACT FROM AUTHOR]

Published
2024
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7. General Population Mortality Adjustment in Survival Extrapolation of Cancer Trials: Exploring Plausibility and Implications for Cost-Effectiveness Analyses in HER2-Positive Breast Cancer in Sweden.

Author

Kim, Kun, Sweeting, Michael, Wilking, Nils, and Jönsson, Linus

Abstract

Background: In economic evaluations of novel therapies, assessing lifetime effects based on trial data often necessitates survival extrapolation, with the choice of model affecting outcomes. The aim of this study was to assess accuracy and variability between alternative approaches to survival extrapolation. Methods: Data on HER2-positive breast cancer patients from the Swedish National Breast Cancer Register were used to fit standard parametric distribution (SPD) models and excess hazard (EH) models adjusting the survival projections based on general population mortality (GPM). Models were fitted using 6-y data for stage I and II, 4-y data for stage III, and 2-y data for stage IV cancer reflecting an early data cutoff while maintaining sufficient events for comparison of model estimates with actual long-term outcomes. We compared model projections of 15-y survival and restricted mean survival time (RMST) to 15-y registry data and explored the variability between models in extrapolations of long-term survival. Results: Among 11,224 patients compared with the observed registry 15-y RMST estimates across the disease stages, EH cure models provided the most accurate estimates in patients with stage I to III cancer, whereas EH models without cure most closely matched survival in patients with stage IV cancer, in which cure assumption was less plausible. The Akaike information criterion–averaged model projections varied as follows: −8.2% to +5.3% for SPD models, −4.9% to +5.2% for the EH model without a cure assumption, and −19.3% to −0.2% for the EH model with a cure assumption. EH models significantly reduced between-model variance in the predicted RMSTs over a 50-y time horizon compared with SPD models. Conclusions: EH models may be considered as alternatives to SPD models to produce more accurate and plausible survival extrapolation that accounts for general population mortality. Highlights: Excess hazard (EH) methods have been suggested as an approach to incorporate background mortality rates in economic evaluation using survival extrapolation. We highlight that EH models with or without a cure assumption can produce more accurate survival projections and significantly reduce between-model variability in comparison with standard parametric distribution models across cancer stages. EH models may be a preferred modeling method to reduce model uncertainty in health economic modeling since models that would otherwise have produced implausible extrapolations are constrained by the EH framework. Reduced uncertainty in economic evaluations will enhance the application of evidence-based health care decision making. [ABSTRACT FROM AUTHOR]

Published
2024
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12. Glycemic index, glycemic load, and risk of coronary heart disease: a pan-European cohort study

Author

Sieri, Sabina, Agnoli, Claudia, Grioni, Sara, Weiderpass, Elisabete, Mattiello, Amalia, Sluijs, Ivonne, Sanchez, Maria Jose, Jakobsen, Marianne Uhre, Sweeting, Michael, van der Schouw, Yvonne T, Nilsson, Lena Maria, Wennberg, Patrik, Katzke, Verena A, Kühn, Tilman, Overvad, Kim, Tong, Tammy YN, Conchi, Moreno-Iribas, Quirós, José Ramón, García-Torrecillas, Juan Manuel, Mokoroa, Olatz, Gómez, Jesús-Humberto, Tjønneland, Anne, Sonestedt, Emiliy, Trichopoulou, Antonia, Karakatsani, Anna, Valanou, Elissavet, Boer, Jolanda MA, Verschuren, WM Monique, Boutron-Ruault, Marie-Christine, Fagherazzi, Guy, Madika, Anne-Laure, Bergmann, Manuela M, Schulze, Matthias B, Ferrari, Pietro, Freisling, Heinz, Lennon, Hannah, Sacerdote, Carlotta, Masala, Giovanna, Tumino, Rosario, Riboli, Elio, Wareham, Nicholas J, Danesh, John, Forouhi, Nita G, Butterworth, Adam S, and Krogh, Vittorio

Published
2020
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13. Development and validation of a universal blood donor genotyping platform: a multinational prospective study

Author

Gleadall, Nicholas S., Veldhuisen, Barbera, Gollub, Jeremy, Butterworth, Adam S., Ord, John, Penkett, Christopher J., Timmer, Tiffany C., Sauer, Carolin M., van der Bolt, Nieke, Brown, Colin, Brugger, Kim, Dilthey, Alexander T., Duarte, Daniel, Grimsley, Shane, van den Hurk, Katja, Jongerius, John M., Luken, Jessie, Megy, Karyn, Miflin, Gail, Nelson, Christopher S., Prinsze, Femmeke J., Sambrook, Jennifer, Simeoni, Ilenia, Sweeting, Michael, Thornton, Nicole, Trompeter, Sara, Tuna, Salih, Varma, Ram, Walker, Matthew R., Danesh, John, Roberts, David J., Ouwehand, Willem H., Stirrups, Kathleen E., Rendon, Augusto, Westhoff, Connie M., Di Angelantonio, Emanuele, van der Schoot, C. Ellen, Astle, William J., Watkins, Nicholas A., and Lane, William J.

Published
2020
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20. Risk thresholds for alcohol consumption: combined analysis of individual-participant data for 599 912 current drinkers in 83 prospective studies

Author

Wood, Angela M, Kaptoge, Stephen, Butterworth, Adam, Willeit, Peter, Warnakula, Samantha, Bolton, Thomas, Paige, Ellie, Paul, Dirk S, Sweeting, Michael, Burgess, Stephen, Bell, Steven, Astle, William, Stevens, David, Koulman, Albert, Selmer, Randi M, Verschuren, Monique, Sato, Shinichi, Njølstad, Inger, Woodward, Mark, Veikko, Salomaa, Nordestgaard, Børge G, Yeap, Bu B, Flecther, Astrid, Melander, Olle, Kuller, Lewis H, Balkau, Beverley, Marmot, Michael, Koenig, Wolfgang, Casiglia, Edoardo, Cooper, Cyrus, Arndt, Volker, Franco, Oscar H, Wennberg, Patrik, Gallacher, John, Gómez de la Cámara, Agustín, Völzke, Henry, Dahm, Christina C, Dale, Caroline E, Bergmann, Manuela, Crespo, Carlos, van der Schouw, Yvonne T, Kaaks, Rudolf, Simons, Leon A, Lagiou, Pagona, Schoufour, Josje D, Boer, Jolanda M.A, Key, Timothy J, Rodriguez, Beatriz, Moreno-Iribas, Conchi, Davidson, Karina W, Taylor, James O, Sacerdote, Carlotta, Wallace, Robert B, Quiros, J. Ramon, Rimm, Eric B, Tumino, Rosario, Blazer III, Dan G, Linneberg, Allan, Daimon, Makoto, Panico, Salvatore, Howard, Barbara, Skeie, Guri, Salomaa, Veikko, Strandberg, Timo, Weiderpass, Elisabete, Nietert, Paul J, Psaty, Bruce M, Kromhout, Daan, Salamanca-Fernandez, Elena, Kiechl, Stefan, Krumholz, Harlan M, Grioni, Sara, Palli, Domenico, Huerta, José M, Price, Jackie, Sundström, Johan, Arriola, Larraitz, Arima, Hisatomi, Travis, Ruth C, Panagiotakos, Demosthenes B, Karakatsani, Anna, Trichopoulou, Antonia, Kühn, Tilman, Grobbee, Diederick E, Barrett-Connor, Elizabeth, van Schoor, Natasja, Boeing, Heiner, Overvad, Kim, Kauhanen, Jussi, Wareham, Nick, Langenberg, Claudia, Forouhi, Nita, Wennberg, Maria, Després, Jean-Pierre, Cushman, Mary, Cooper, Jackie A, Rodriguez, Carlos J, Sakurai, Masaru, Shaw, Jonathan E, Knuiman, Matthew, Voortman, Trudy, Meisinger, Christa, Tjønneland, Anne, Brenner, Hermann, Palmieri, Luigi, Dallongeville, Jean-Pierre, Brunner, Eric J, Assmann, Gerd, Trevisan, Maurizio, Gillumn, Richard F, Ford, Ian Ford, Sattar, Naveed, Lazo, Mariana, Thompson, Simon, Ferrari, Pietro, Leon, David A, Davey Smith, George, Peto, Richard, Jackson, Rod, Banks, Emily, Di Angelantonio, Emanuele, Danesh, John, Butterworth, Adam S, Verschuren, W M Monique, Fletcher, Astrid, de la Cámara, Agustín Gómez, Bergmann, Manuela M, Crespo, Carlos J, Boer, Jolanda M A, Quiros, J Ramon, Blazer, Dan G, II, Dallongeville, Jean, Gillum, Richard F, Ford, Ian, Thompson, Simon G, and Smith, George Davey

Published
2018
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23. Lifestyle factors and risk of multimorbidity of cancer and cardiometabolic diseases: a multinational cohort study

Author

Freisling, Heinz, Viallon, Vivian, Lennon, Hannah, Bagnardi, Vincenzo, Ricci, Cristian, Butterworth, Adam S., Sweeting, Michael, Muller, David, Romieu, Isabelle, Bazelle, Pauline, Kvaskoff, Marina, Arveux, Patrick, Severi, Gianluca, Bamia, Christina, Kühn, Tilman, Kaaks, Rudolf, Bergmann, Manuela, Boeing, Heiner, Tjønneland, Anne, Olsen, Anja, Overvad, Kim, Dahm, Christina C., Menéndez, Virginia, Agudo, Antonio, Sánchez, Maria-Jose, Amiano, Pilar, Santiuste, Carmen, Gurrea, Aurelio Barricarte, Tong, Tammy Y. N., Schmidt, Julie A., Tzoulaki, Ioanna, Tsilidis, Konstantinos K., Ward, Heather, Palli, Domenico, Agnoli, Claudia, Tumino, Rosario, Ricceri, Fulvio, Panico, Salvatore, Picavet, H. Susan J., Bakker, Marije, Monninkhof, Evelyn, Nilsson, Peter, Manjer, Jonas, Rolandsson, Olov, Thysell, Elin, Weiderpass, Elisabete, Jenab, Mazda, Riboli, Elio, Vineis, Paolo, Danesh, John, Wareham, Nick J., Gunter, Marc J., and Ferrari, Pietro

Published
2020
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24. Influence of cardiometabolic medications on abdominal aortic aneurysm growth in the UK Aneurysm Growth Study: metformin and angiotensin-converting enzyme inhibitors associated with slower aneurysm growth.

Author

Gellatly, Corry, Sweeting, Michael, Emin, Atilla, Katsogridakis, Emmanuel, Finch, Sarah, Saratzis, Athanasios, Bown, Matthew J, UKAGS Investigators and Collaborators, Asani, Furaha, Asiani, Manish, Barber, Jonathon, Barwell, Jamie, Baker, Sara, Brooks, Marcus, Browning, Neil, Chamberlain, Julie, Chandarana, Kundan, Chetter, Ian, Choksy, Sohail, and Clay, Caroline

Subjects
*ABDOMINAL aortic aneurysms, *DISEASE progression, *ACE inhibitors, *ANGIOTENSIN-receptor blockers, *ANGIOTENSIN II, *DRUGS, *METFORMIN, *NICOTINE replacement therapy
Abstract

Background: There is a clinical need for treatments that can slow or prevent the growth of an abdominal aortic aneurysm, not only to reduce the need for surgery, but to provide a means to treat those who cannot undergo surgery. Methods: Analysis of the UK Aneurysm Growth Study (UKAGS) prospective cohort was conducted to test for an association between cardiometabolic medications and the growth of an abdominal aortic aneurysm above 30 mm in diameter, using linear mixed-effect models. Results: A total of 3670 male participants with data available on abdominal aortic aneurysm growth, smoking status, co-morbidities, and medication history were included. The mean age at recruitment was 69.5 years, the median number of surveillance scans was 6, and the mean(s.e.) unadjusted abdominal aortic aneurysm growth rate was 1.75(0.03) mm/year. In a multivariate linear mixed-effect model, smoking (mean(s.e.) +0.305(0.07) mm/year, P = 0.00003) and antiplatelet use (mean(s.e.) +0.235(0.06) mm/year, P = 0.00018) were found to be associated with more rapid abdominal aortic aneurysm growth, whilst metformin was strongly associated with slower abdominal aortic aneurysm growth (mean(s.e.) −0.38(0.1) mm/year, P = 0.00019), as were angiotensin-converting enzyme inhibitors (mean(s.e.) −0.243(0.07) mm/year, P = 0.0004), angiotensin II receptor antagonists (mean(s.e.) −0.253(0.08) mm/year, P = 0.00255), and thiazides/related diuretics (mean(s.e.) −0.307(0.09) mm/year, P = 0.00078). Conclusion: The strong association of metformin with slower abdominal aortic aneurysm growth highlights the importance of the ongoing clinical trials assessing the effectiveness of metformin with regard to the prevention of abdominal aortic aneurysm growth and/or rupture. The association of angiotensin-converting enzyme inhibitors, angiotensin II receptor antagonists, and diuretics with slower abdominal aortic aneurysm growth points to the possibility that optimization of cardiovascular risk management as part of abdominal aortic aneurysm surveillance may have the secondary benefit of also reducing abdominal aortic aneurysm growth rates. Abdominal aortic aneurysm growth rates were compared with smoking status, co-morbidities, and medication history in the UK Aneurysm Growth Study (UKAGS) prospective cohort. It was found that: smoking and antiplatelet use were associated with a more rapid abdominal aortic aneurysm growth rate; the drug metformin was strongly associated with a slower abdominal aortic aneurysm growth rate; and drugs in the angiotensin-converting enzyme inhibitor, angiotensin II receptor antagonist, and thiazide/related diuretic classes were also associated with a slower abdominal aortic aneurysm growth rate. These results suggest that common cardiometabolic medications may be useful therapeutic options to slow abdominal aortic aneurysm growth rates. [ABSTRACT FROM AUTHOR]

Published
2024
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27. Natriuretic peptides and integrated risk assessment for cardiovascular disease: an individual-participant-data meta-analysis

Author

Willeit, Peter, Kaptoge, Stephen, Welsh, Paul, Butterworth, Adam S, Chowdhury, Rajiv, Spackman, Sarah A, Pennells, Lisa, Gao, Pei, Burgess, Stephen, Freitag, Daniel F, Sweeting, Michael, Wood, Angela M, Cook, Nancy R, Judd, Suzanne, Trompet, Stella, Nambi, Vijay, Olsen, Michael Hecht, Everett, Brendan M, Kee, Frank, Ärnlöv, Johan, Salomaa, Veikko, Levy, Daniel, Kauhanen, Jussi, Laukkanen, Jari A, Kavousi, Maryam, Ninomiya, Toshiharu, Casas, Juan-Pablo, Daniels, Lori B, Lind, Lars, Kistorp, Caroline N, Rosenberg, Jens, Mueller, Thomas, Rubattu, Speranza, Panagiotakos, Demosthenes B, Franco, Oscar H, de Lemos, James A, Luchner, Andreas, Kizer, Jorge R, Kiechl, Stefan, Salonen, Jukka T, Wannamethee, S Goya, de Boer, Rudolf A, Nordestgaard, Børge G, Andersson, Jonas, Jørgensen, Torben, Melander, Olle, Ballantyne, Christie M, DeFilippi, Christopher, Ridker, Paul M, Cushman, Mary, Rosamond, Wayne D, Thompson, Simon G, Gudnason, Vilmundur, Sattar, Naveed, Danesh, John, and Di Angelantonio, Emanuele

Published
2016
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28. Consumption of Meat, Fish, Dairy Products, and Eggs and Risk of Ischemic Heart Disease: A Prospective Study of 7198 Incident Cases Among 409 885 Participants in the Pan-European EPIC Cohort

Author

Key, Timothy J., Appleby, Paul N., Bradbury, Kathryn E., Sweeting, Michael, Wood, Angela, Johansson, Ingegerd, Kühn, Tilman, Steur, Marinka, Weiderpass, Elisabete, Wennberg, Maria, Lund Würtz, Anne Mette, Agudo, Antonio, Andersson, Jonas, Arriola, Larraitz, Boeing, Heiner, Boer, Jolanda M.A., Bonnet, Fabrice, Boutron-Ruault, Marie-Christine, Cross, Amanda J., Ericson, Ulrika, Fagherazzi, Guy, Ferrari, Pietro, Gunter, Marc, Huerta, José María, Katzke, Verena, Khaw, Kay-Tee, Krogh, Vittorio, La Vecchia, Carlo, Matullo, Giuseppe, Moreno-Iribas, Conchi, Naska, Androniki, Nilsson, Lena Maria, Olsen, Anja, Overvad, Kim, Palli, Domenico, Panico, Salvatore, Molina-Portillo, Elena, Quirós, J. Ramón, Skeie, Guri, Sluijs, Ivonne, Sonestedt, Emily, Stepien, Magdalena, Tjønneland, Anne, Trichopoulou, Antonia, Tumino, Rosario, Tzoulaki, Ioanna, van der Schouw, Yvonne T., Verschuren, W.M. Monique, di Angelantonio, Emanuele, Langenberg, Claudia, Forouhi, Nita, Wareham, Nick, Butterworth, Adam, Riboli, Elio, and Danesh, John

Published
2019
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30. Prevalence of opioid dependence in New South Wales, Australia, 2014–16: Indirect estimation from multiple data sources using a Bayesian approach.

Author

Downing, Beatrice C., Hickman, Matthew, Jones, Nicola R., Larney, Sarah, Sweeting, Michael J., Xu, Yixin, Farrell, Michael, Degenhardt, Louisa, and Jones, Hayley E.

Subjects
DRUG addiction, CONFIDENCE intervals, AGE distribution, SEX distribution, RESEARCH funding, OPIOID analgesics, STATISTICAL models, PROBABILITY theory
Abstract

Aims: To estimate the prevalence of, and number of unobserved people with opioid dependence by sex and age group in New South Wales (NSW), Australia. Design: We applied a Bayesian statistical modelling approach to opioid agonist treatment records linked to adverse event rate data. We estimated prevalence from three types of adverse event separately: opioid mortality, opioid‐poisoning hospitalizations and opioid‐related charges. We extended the model and produced prevalence estimates from a 'multi‐source' model based on all three types of adverse event data. Setting, Participants and Measurements: This study was conducted in NSW, Australia, 2014–16 using data from the Opioid Agonist Treatment and Safety (OATS) study, which included all people who had received treatment for opioid dependence in NSW. Aggregate data were obtained on numbers of adverse events in NSW. Rates of each adverse event type within the OATS cohort were modelled. Population data were provided by State and Commonwealth agencies. Findings Prevalence of opioid dependence among those aged 15–64 years in 2016 was estimated to be 0.96% (95% credible interval [CrI] = 0.82%, 1.12%) from the mortality model, 0.75% (95% CrI = 0.70%, 0.83%) from hospitalizations, 0.95% (95% CrI = 0.90%, 0.99%) from charges and 0.92% (95% CrI = 0.88%, 0.96%) from the multi‐source model. Of the estimated 46 460 (95% CrI = 44 680, 48 410) people with opioid dependence in 2016 from the multi‐source model, approximately one‐third (16 750, 95% CrI = 14 960, 18 690) had no record of opioid agonist treatment within the last 4 years. From the multi‐source model, prevalence in 2016 was estimated to be 1.24% (95% CrI = 1.18%, 1.31%) in men aged 15–44, 1.22% (95% CrI = 1.14%, 1.31%) in men 45–64, 0.63% (95% CrI = 0.59%, 0.68%) in women aged 15–44 and 0.56% (95% CrI = 0.50%, 0.63%) in women aged 45–64. Conclusions: A Bayesian statistical approach to estimate prevalence from multiple adverse event types simultaneously calculates that the estimated prevalence of opioid dependence in NSW, Australia in 2016 was 0.92%, higher than previous estimates. [ABSTRACT FROM AUTHOR]

Published
2023
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32. Survival Extrapolation Incorporating General Population Mortality Using Excess Hazard and Cure Models: A Tutorial.

Author

Sweeting, Michael J., Rutherford, Mark J., Jackson, Dan, Lee, Sangyu, Latimer, Nicholas R., Hettle, Robert, and Lambert, Paul C.

Abstract

Background: Different parametric survival models can lead to widely discordant extrapolations and decision uncertainty in cost-effectiveness analyses. The use of excess hazard (EH) methods, which incorporate general population mortality data, has the potential to reduce model uncertainty. This review highlights key practical considerations of EH methods for estimating long-term survival. Methods: Demonstration of methods used a case study of 686 patients from the German Breast Cancer Study Group, followed for a maximum of 7.3 y and divided into low (1/2) and high (3) grade cancers. Seven standard parametric survival models were fit to each group separately. The same 7 distributions were then used in an EH framework, which incorporated general population mortality rates, and fitted both with and without a cure parameter. Survival extrapolations, restricted mean survival time (RMST), and difference in RMST between high and low grades were compared up to 30 years along with Akaike information criterion goodness-of-fit and cure fraction estimates. The sensitivity of the EH models to lifetable misspecification was investigated. Results: In our case study, variability in survival extrapolations was extensive across the standard models, with 30-y RMST ranging from 7.5 to 14.3 y. Incorporation of general population mortality rates using EH cure methods substantially reduced model uncertainty, whereas EH models without cure had less of an effect. Long-term treatment effects approached the null for most models but at varying rates. Lifetable misspecification had minimal effect on RMST differences. Conclusions: EH methods may be useful for survival extrapolation, and in cancer, EHs may decrease over time and be easier to extrapolate than all-cause hazards. EH cure models may be helpful when cure is plausible and likely to result in less extrapolation variability. Highlights: In health economic modeling, to help anchor long-term survival extrapolation, it has been recommended that survival models incorporate background mortality rates using excess hazard (EH) methods. We present a thorough description of EH methods with and without the assumption of cure and demonstrate user-friendly software to aid researchers wishing to use these methods. EH models are applied to a case study, and we demonstrate that EHs are easier to extrapolate and that the use of the EH cure model, when cure is plausible, can reduce extrapolation variability. EH methods are relatively robust to lifetable misspecification. [ABSTRACT FROM AUTHOR]

Published
2023
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35. Use of Repeated Blood Pressure and Cholesterol Measurements to Improve Cardiovascular Disease Risk Prediction: An Individual-Participant-Data Meta-Analysis

Author

Paige, Ellie, Barrett, Jessica, Pennells, Lisa, Sweeting, Michael, Willeit, Peter, Di Angelantonio, Emanuele, Gudnason, Vilmundur, Nordestgaard, Børge G., Psaty, Bruce M, Goldbourt, Uri, Best, Lyle G, Assmann, Gerd, Salonen, Jukka T, Nietert, Paul J, Verschuren, W. M. Monique, Brunner, Eric J, Kronmal, Richard A, Salomaa, Veikko, Bakker, Stephan J L, Dagenais, Gilles R, Sato, Shinichi, Jansson, Jan-Håkan, Willeit, Johann, Onat, Altan, de la Cámara, Agustin Gómez, Roussel, Ronan, Völzke, Henry, Dankner, Rachel, Tipping, Robert W, Meade, Tom W, Donfrancesco, Chiara, Kuller, Lewis H, Peters, Annette, Gallacher, John, Kromhout, Daan, Iso, Hiroyasu, Knuiman, Matthew, Casiglia, Edoardo, Kavousi, Maryam, Palmieri, Luigi, Sundström, Johan, Davis, Barry R, Njølstad, Inger, Couper, David, Danesh, John, Thompson, Simon G, and Wood, Angela

Published
2017
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37. Sex-specific differences in the standard of care for infrarenal abdominal aortic aneurysm repair, and risk of major adverse cardiovascular events and death.

Author

Pouncey, Anna L., Sweeting, Michael J., Bicknell, Colin, and Powell, Janet T.

Subjects
*ABDOMINAL aortic aneurysms, *MAJOR adverse cardiovascular events, CARDIOVASCULAR disease related mortality
Abstract

Background: This study investigated whether sex-specific differences in preoperative/perioperative standard of care (SOC) account for disparity in outcomes after elective infrarenal abdominal aortic aneurysm repair. Methods: This was a retrospective cohort study of elective infrarenal abdominal aortic aneurysm repairs (2013-2020) using depersonalized patient-level National Vascular Registry data. SOC was defined for waiting times, preoperative assessment (multidisciplinary/anaesthetic review), cardiovascular risk prevention, and perioperative medication. The primary outcome was major cardiovascular event and/or death (MACED). Results: Some 21 810 patients with an infrarenal abdominal aortic aneurysm were included, 2380 women and 19 430 men. Women less often underwent aneurysm repair within SOC waiting times (51.5 versus 59.3 per cent; P<0.001), but were equally likely to receive preoperative assessment (72.1 versus 72.5 per cent; P=0.742). Women were less likely to receive secondary prevention for known cardiac disease (34.9 versus 39.6 per cent; P=0.015), but more often met overall cardiovascular risk prevention standards (52.1 versus 47.3 per cent; P<0.001). Women were at greater risk of MACED (open: 12.0 versus 8.9 per cent, P<0.001; endovascular: 4.9 versus 2.9 per cent, P<0.001; risk-adjusted OR 1.33, 95 per cent c.i. 1.12 to 1.59). A significant reduction in the odds of MACED was associated with preoperative assessment (OR 0.86, 0.75 to 0.98) and SOC waiting times (OR 0.78, 0.69 to 0.87). There was insufficient evidence to confirm a significant sex-specific difference in the effect of SOC preoperative assessment (women: OR 0.69, 0.50 to 0.97; men: OR 0.89, 0.77 to 1.03; interaction P=0.170) or SOC waiting times (women: OR 0.84, 0.62 to 1.16; men: OR 0.76, 0.67 to 0.87; interaction P= 0.570) on the risk of MACED. Conclusion: SOC waiting times and preoperative assessment were not met for both sexes, which was associated with an increased risk of MACED. Sex-specific differences in SOC attenuated but did not fully account for the increased risk of MACED in women. [ABSTRACT FROM AUTHOR]

Published
2023
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38. Endovascular strategy or open repair for ruptured abdominal aortic aneurysm: one-year outcomes from the IMPROVE randomized trial

Author

Braithwaite, Bruce, Cheshire, Nicholas J., Greenhalgh, Roger M., Grieve, Richard, Hassan, Tajek B., Hinchliffe, Robert, Howell, Simon, Moore, Fionna, Nicholson, Anthony A., Soong, Chee V., Thompson, Matt M., Thompson, Simon G., Ulug, Pinar, Heatley, Francine, Anjum, Aisha, Kalinowska, Gosia, Sweeting, Michael J., Thompson, Simon G., Gomes, Manuel, Grieve, Richard, Powell, Janet T., Ashleigh, Ray, Gomes, Manuel, Greenhalgh, Roger M., Grieve, Richard, Hinchliffe, Robert, Sweeting, Michael, Thompson, Matt M., Thompson, Simon G., Ulug, Pinar, Roberts, Ian, Bell, Peter R. F., Cheetham, Anne, Stephany, Jenny, Warlow, Charles, Lamont, Peter, Moss, Jonathan, Tijssen, Jan, Braithwaite, Bruce, Nicholson, Anthony A., Thompson, Matthew, Ashleigh, Ray, Thompson, Luke, Cheshire, Nicholas J., Boyle, Jonathan R., Serracino-Inglott, Ferdinand, Thompson, Matt M., Hinchliffe, Robert J., Bell, Rachel, Wilson, Noel, Bown, Matt, Dennis, Martin, Davis, Meryl, Ashleigh, Ray, Howell, Simon, Wyatt, Michael G., Valenti, Domenico, Bachoo, Paul, Walker, Paul, MacSweeney, Shane, Davies, Jonathan N., Rittoo, Dynesh, Parvin, Simon D., Yusuf, Waquar, Nice, Colin, Chetter, Ian, Howard, Adam, Chong, Patrick, Bhat, Raj, McLain, David, Gordon, Andrew, Lane, Ian, Hobbs, Simon, Pillay, Woolagasen, Rowlands, Timothy, El-Tahir, Amin, Asquith, John, Cavanagh, Steve, Dubois, Luc, Forbes, Thomas L., Ashworth, Emily, Baker, Sara, Barakat, Hashem, Brady, Claire, Brown, Joanne, Bufton, Christine, Chance, Tina, Chrisopoulou, Angela, Cockell, Marie, Croucher, Andrea, Dabee, Leela, Dewhirst, Nikki, Evans, Jo, Gibson, Andy, Gorst, Siobhan, Gough, Moira, Graves, Lynne, Griffin, Michelle, Hatfield, Josie, Hogg, Florence, Howard, Susannah, Hughes, Cían, Metcalfe, David, Lapworth, Michelle, Massey, Ian, Novick, Teresa, Owen, Gareth, Parr, Noala, Pintar, David, Spencer, Sarah, Thomson, Claire, Thunder, Orla, Wallace, Tom, Ward, Sue, Wealleans, Vera, Wilson, Lesley, Woods, Janet, and Zheng, Ting

Published
2015
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39. Carotid Intima-Media Thickness Progression as Surrogate Marker for Cardiovascular Risk

Author

Willeit, Peter, Tschiderer, Lena, Allara, Elias, Reuber, Kathrin, Seekircher, Lisa, Gao, Lu, Liao, Ximing, Lonn, Eva, Gerstein, Hertzel C, Yusuf, Salim, Brouwers, Frank P, Asselbergs, Folkert W, Van Gilst, Wiek, Anderssen, Sigmund A, Grobbee, Diederick E, Kastelein, John JP, Visseren, Frank LJ, Ntaios, George, Hatzitolios, Apostolos I, Savopoulos, Christos, Nieuwkerk, Pythia T, Stroes, Erik, Walters, Matthew, Higgins, Peter, Dawson, Jesse, Gresele, Paolo, Guglielmini, Giuseppe, Migliacci, Rino, Ezhov, Marat, Safarova, Maya, Balakhonova, Tatyana, Sato, Eiichi, Amaha, Mayuko, Nakamura, Tsukasa, Kapellas, Kostas, Jamieson, Lisa M, Skilton, Michael, Blumenthal, James A, Hinderliter, Alan, Sherwood, Andrew, Smith, Patrick J, Van Agtmael, Michiel A, Reiss, Peter, Van Vonderen, Marit GA, Kiechl, Stefan, Klingenschmid, Gerhard, Sitzer, Matthias, Stehouwer, Coen DA, Uthoff, Heiko, Zou, Zhi-Yong, Cunha, Ana R, Neves, Mario F, Witham, Miles D, Park, Hyun-Woong, Lee, Moo-Sik, Bae, Jang-Ho, Bernal, Enrique, Wachtell, Kristian, Kjeldsen, Sverre E, Olsen, Michael H, Preiss, David, Sattar, Naveed, Beishuizen, Edith, Huisman, Menno V, Espeland, Mark A, Schmidt, Caroline, Agewall, Stefan, Ok, Ercan, Aşçi, Gülay, De Groot, Eric, Grooteman, Muriel PC, Blankestijn, Peter J, Bots, Michiel L, Sweeting, Michael J, Thompson, Simon G, Lorenz, Matthias W, PROG-IMT And The Proof-ATHERO Study Groups, Group, PROG-IMT Study, Group, Proof-ATHERO Study, Vascular Medicine, Medical Psychology, APH - Mental Health, APH - Personalized Medicine, Experimental Vascular Medicine, ACS - Atherosclerosis & ischemic syndromes, Global Health, APH - Aging & Later Life, AGEM - Amsterdam Gastroenterology Endocrinology Metabolism, ACS - Pulmonary hypertension & thrombosis, Ege Üniversitesi, MUMC+: Centrum voor Chronische Zieken (3), MUMC+: MA Med Staf Artsass Interne Geneeskunde (9), RS: Carim - V01 Vascular complications of diabetes and metabolic syndrome, MUMC+: HVC Pieken Maastricht Studie (9), Interne Geneeskunde, MUMC+: MA Interne Geneeskunde (3), Allara, Elias [0000-0002-1634-8330], Apollo - University of Cambridge Repository, Cardiovascular Centre (CVC), Internal medicine, Nephrology, and ACS - Diabetes & metabolism

Subjects
Male, medicine.medical_specialty, Carotid Artery, Common, carotid intima-media thickness, LDL TREATMENT STRATEGIES, Myocardial Infarction, surrogate marker, TYPE-2 DIABETES-MELLITUS, HIV-INFECTED PATIENTS, 030204 cardiovascular system & hematology, Impaired glucose tolerance, EXTENDED-RELEASE NIACIN, 03 medical and health sciences, 0302 clinical medicine, IMPAIRED GLUCOSE-TOLERANCE, ESTROGEN PLUS PROGESTIN, cardiovascular disease, Physiology (medical), Internal medicine, BASE-LINE CHARACTERISTICS, medicine, Humans, CORONARY-HEART-DISEASE, 030212 general & internal medicine, Myocardial infarction, cardiovascular diseases, Stroke, Randomized Controlled Trials as Topic, clinical trials as topic, business.industry, Surrogate endpoint, Middle Aged, medicine.disease, Common, Clinical trial, meta-analysis, ARTERIAL-WALL THICKNESS, Intima-media thickness, JAPAN STATIN TREATMENT, Heart Disease Risk Factors, Relative risk, Meta-analysis, Cardiology, cardiovascular system, Female, Carotid Artery, Cardiology and Cardiovascular Medicine, business
Abstract

Background: To quantify the association between effects of interventions on carotid intima-media thickness (cIMT) progression and their effects on cardiovascular disease (CVD) risk. Methods: We systematically collated data from randomized, controlled trials. cIMT was assessed as the mean value at the common-carotid-artery; if unavailable, the maximum value at the common-carotid-artery or other cIMT measures were used. the primary outcome was a combined CVD end point defined as myocardial infarction, stroke, revascularization procedures, or fatal CVD. We estimated intervention effects on cIMT progression and incident CVD for each trial, before relating the 2 using a Bayesian meta-regression approach. Results: We analyzed data of 119 randomized, controlled trials involving 100 667 patients (mean age 62 years, 42% female). Over an average follow-up of 3.7 years, 12 038 patients developed the combined CVD end point. Across all interventions, each 10 mu m/y reduction of cIMT progression resulted in a relative risk for CVD of 0.91 (95% Credible Interval, 0.87-0.94), with an additional relative risk for CVD of 0.92 (0.87-0.97) being achieved independent of cIMT progression. Taken together, we estimated that interventions reducing cIMT progression by 10, 20, 30, or 40 mu m/y would yield relative risks of 0.84 (0.75-0.93), 0.76 (0.67-0.85), 0.69 (0.59-0.79), or 0.63 (0.52-0.74), respectively. Results were similar when grouping trials by type of intervention, time of conduct, time to ultrasound follow-up, availability of individual-participant data, primary versus secondary prevention trials, type of cIMT measurement, and proportion of female patients. Conclusions: the extent of intervention effects on cIMT progression predicted the degree of CVD risk reduction. This provides a missing link supporting the usefulness of cIMT progression as a surrogate marker for CVD risk in clinical trials., Austrian Science Fund (FWF)Austrian Science Fund (FWF) [P 32488]; Dr-Johannes-and-Hertha-Tuba Foundation; German Research FoundationGerman Research Foundation (DFG) [DFG Lo 1569/2-1, DFG Lo 1569/2-3]; excellence initiative "Competence Centers for Excellent Technologies" (COMET) of the Austrian Research Promotion Agency (FFG) "Research Center of Excellence in Vascular Ageing: Tyrol, VAS-Cage" - Bundesministerium fur Verkehr, Innovation und Technologie (B [843536]; Bundesministerium fur Bildung, Wissenschaft und Forschung (BMWFW); Wirtschaftsagentur Wien; Standortagentur Tirol, This work was supported by the Austrian Science Fund (FWF; P 32488); the Dr-Johannes-and-Hertha-Tuba Foundation; the German Research Foundation (DFG Lo 1569/2-1 and DFG Lo 1569/2-3); and the excellence initiative "Competence Centers for Excellent Technologies" (COMET) of the Austrian Research Promotion Agency (FFG) "Research Center of Excellence in Vascular Ageing: Tyrol, VAS-Cage" (K-Project No. 843536), funded by Bundesministerium fur Verkehr, Innovation und Technologie (BMVIT), Bundesministerium fur Bildung, Wissenschaft und Forschung (BMWFW), Wirtschaftsagentur Wien, and Standortagentur Tirol.

Published
2020
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41. Impact of a post‐donation hemoglobin testing strategy on efficiency and safety of whole blood donation in England: A modeling study.

Author

Kim, Lois G., Bolton, Thomas, Sweeting, Michael J., Bell, Steven, Fahle, Sarah, McMahon, Amy, Walker, Matthew, Ferguson, Eamonn, Miflin, Gail, Roberts, David J., Di Angelantonio, Emanuele, and Wood, Angela M.

Subjects
HEMOGLOBINS, DISCRETE event simulation
Abstract

Background: Deferrals due to low hemoglobin are time‐consuming and costly for blood donors and donation services. Furthermore, accepting donations from those with low hemoglobin could represent a significant safety issue. One approach to reduce them is to use hemoglobin concentration alongside donor characteristics to inform personalized inter‐donation intervals. Study Design and Methods: We used data from 17,308 donors to inform a discrete event simulation model comparing personalized inter‐donation intervals using "post‐donation" testing (i.e., estimating current hemoglobin from that measured by a hematology analyzer at last donation) versus the current approach in England (i.e., pre‐donation testing with fixed intervals of 12‐weeks for men and 16‐weeks for women). We reported the impact on total donations, low hemoglobin deferrals, inappropriate bleeds, and blood service costs. Personalized inter‐donation intervals were defined using mixed‐effects modeling to estimate hemoglobin trajectories and probability of crossing hemoglobin donation thresholds. Results: The model had generally good internal validation, with predicted events similar to those observed. Over 1 year, a personalized strategy requiring ≥90% probability of being over the hemoglobin threshold, minimized adverse events (low hemoglobin deferrals and inappropriate bleeds) in both sexes and costs in women. Donations per adverse event improved from 3.4 (95% uncertainty interval 2.8, 3.7) under the current strategy to 14.8 (11.6, 19.2) in women, and from 7.1 (6.1, 8.5) to 26.9 (20.8, 42.6) in men. In comparison, a strategy incorporating early returns for those with high certainty of being over the threshold maximized total donations in both men and women, but was less favorable in terms of adverse events, with 8.4 donations per adverse event in women (7.0, 10,1) and 14.8 (12.1, 21.0) in men. Discussion: Personalized inter‐donation intervals using post‐donation testing combined with modeling of hemoglobin trajectories can help reduce deferrals, inappropriate bleeds, and costs. [ABSTRACT FROM AUTHOR]

Published
2023
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42. Cancer history as a predictor in cardiovascular risk scores: a primary care cohort study.

Author

Strongman, Helen, Herrett, Emily, Jackson, Rod, Sweeting, Michael, Lyon, Alexander R, Stanway, Susannah, Lawson, Claire, Kadam, Umesh, Smeeth, Liam, and Bhaskaran, Krishnan

Subjects
DISEASE risk factors, CARDIOVASCULAR diseases risk factors, PROPORTIONAL hazards models, CEREBROVASCULAR disease, COHORT analysis, PRIMARY care
Abstract

Background: Cardiovascular risks are raised in cancer survivors but cancer history is not included in cardiovascular risk scores that inform preventive decisions. Aim: To assess whether cancer diagnosis should be included in cardiovascular risk scores. Design and setting: Cohort study using data from English general practices linked to hospital, cancer registration, and death registration data from 1990 to 2015. Method: Adults alive 1 year after a first cancer diagnosis and age, sex, general practice, and calendar- time matched cancer-free individuals were included. Individuals with <2 years of follow-up before index, recent statin prescriptions, or pre-existing coronary heart or cerebrovascular disease were excluded. Cox proportional hazard models used to develop QRISK3 scores were replicated with added cancer history variables. Whether independent hazard ratios for these variables met thresholds for inclusion in QRISK3 (>10% relative difference with P<0.01) was assessed. Results: In total, 81 420 cancer survivors and 413 547 cancer-free individuals were followed for a median 5.2 years (interquartile range [IQR] 2.8– 9.1) and 6.3 years (IQR 3.5–10.2), respectively. Including a 1-year cancer survivorship variable in a QRISK3-based model met the threshold for inclusion for males (independent hazard ratio [iHR] 1.16, 95% confidence interval [CI] = 1.11 to 1.20, P<0.001) but not females (iHR 1.07, 95% CI = 1.01 to 1.14, P = 0.02). When including cancer type, the threshold was met for both sexes with history of haematological cancer (males: iHR 1.27, 95% CI = 1.16 to 1.40, P <0.001; females: iHR 1.59, 95% CI = 1.32 to 1.91, P<0.001) and for males but not females with history of solid cancers (males: iHR 1.13, 95% CI = 1.08 to 1.18, P <0.001; females: iHR 1.04, 95% CI = 0.98 to 1.10, P = 0.19). Conclusion: Developers should consider including cancer history variables in future cardiovascular risk models. [ABSTRACT FROM AUTHOR]

Published
2023
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44. The effect of aortic morphology on peri-operative mortality of ruptured abdominal aortic aneurysm

Author

Anjum, A., Thompson, L., Azhar, B., Hughes, C., Karthikesalingam, A., Ashleigh, R., Thompson, M.M., Cheshire, Nicholas J., Boyle, Jonathan R., Serracino-Inglott, Ferdinand, Vince Smyth, J., Thompson, Matt M., Hinchliffe, Robert J., Bell, Rachel, Wilson, Noel, Bown, Matt, Dennis, Martin, Davis, Meryl, Ashleigh, Ray, Howell, Simon, Wyatt, Michael G., Valenti, Domenico, Bachoo, Paul, Walker, Paul, MacSweeney, Shane, Davies, Jonathan N., Rittoo, Dynesh, Parvin, Simon D., Yusuf, Waquar, Nice, Colin, Chetter, Ian, Howard, Adam, Chong, Patrick, Bhat, Raj, McLain, David, Gordon, Andrew, Lane, Ian, Hobbs, Simon, Pillay, Woolagasen, Rowlands, Timothy, El-Tahir, Amin, Asquith, John, Cavanagh, Steve, Forbes, Thomas L., Awopetu, Ayoola, Baker, Sara, Bourke, Patricia, Brady, Claire, Brown, Joanne, Bryce, Jennie, Bufton, Christine, Chance, Tina, Chrisopoulou, Angela, Cockell, Marie, Croucher, Andrea, Curran, Gail, Dabee, Leela, Dewhirst, Nikki, Evans, Jo, Gibson, Andy, Gorst, Siobhan, Gough, Moira, Graves, Lynne, Griffin, Michelle, Hatfield, Josie, Hogg, Florence, Howard, Susannah, Hughes, Thomas, James, Alex, Metcalfe, David, Lapworth, Michelle, Massey, Ian, Mohalhal, Awad, Novick, Teresa, Owen, Gareth, Parr, Noala, Pintar, David, Smith, Tom, Spencer, Sarah, Thomson, Claire, Thunder, Orla, Wallace, Tom, Ward, Sue, Wealleans, Vera, Wilson, Lesley, Woods, Janet, Zachariah, Manu, Zheng, Ting, Powell, Janet T., Sweeting, Michael J., Thompson, Matthew M., Hinchliffe, Robert J., Ashleigh, Ray, Bell, Rachel, Greenhalgh, Roger M., Thompson, Simon G., and Ulug, Pinar

Published
2015
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46. Case-ascertainment of acute myocardial infarction hospitalizations in cancer patients: a cohort study using English linked electronic health data

Author

Coles, Briana, Teece, Lucy, Weston, Clive, de Belder, Mark A, Oliver-Williams, Clare, Welch, Catherine A, Rutherford, Mark J, Lambert, Paul C, Bidulka, Patrick, Paley, Lizz, Nitsch, Dorothea, Deanfield, John, Peake, Mick D, Adlam, David, and Sweeting, Michael J

Subjects
cardiovascular diseases
Abstract

AIMS: To assess the recording and accuracy of acute myocardial infarction (AMI) hospital admissions between two electronic health record databases within an English cancer population over time and understand the factors that affect case-ascertainment. METHODS AND RESULTS: We identified 112 502 hospital admissions for AMI in England 2010-2017 from the Myocardial Ischaemia National Audit Project (MINAP) disease registry and hospital episode statistics (HES) for 95 509 patients with a previous cancer diagnosis up to 15 years prior to admission. Cancer diagnoses were identified from the National Cancer Registration Dataset (NCRD). We calculated the percentage of AMI admissions captured by each source and examined patient characteristics associated with source of ascertainment. Survival analysis assessed whether differences in survival between case-ascertainment sources could be explained by patient characteristics. A total of 57 265 (50.9%) AMI admissions in patients with a prior diagnosis of cancer were captured in both MINAP and HES. Patients captured in both sources were younger, more likely to have ST-segment elevation myocardial infarction and had better prognosis, with lower mortality rates up to 9 years after AMI admission compared with patients captured in only one source. The percentage of admissions captured in both data sources improved over time. Cancer characteristics (site, stage, and grade) had little effect on how AMI was captured. CONCLUSION: MINAP and HES define different populations of patients with AMI. However, cancer characteristics do not substantially impact on case-ascertainment. These findings support a strategy of using multiple linked data sources for observational cardio-oncological research into AMI.

Published
2021

47. The Validity of Surrogate Endpoints in Sub Groups of Metastatic Colorectal Cancer Patients Defined by Treatment Class and KRAS Status.

Author

Poad, Heather, Khan, Sam, Wheaton, Lorna, Thomas, Anne, Sweeting, Michael, and Bujkiewicz, Sylwia

Subjects
THERAPEUTIC use of antineoplastic agents, GENETIC mutation, META-analysis, SYSTEMATIC reviews, CANCER chemotherapy, EPIDERMAL growth factor receptors, METASTASIS, ANTINEOPLASTIC agents, COLORECTAL cancer, TREATMENT effectiveness, SURVIVAL analysis (Biometry), TUMOR markers, PROGRESSION-free survival, EVALUATION
Abstract

Simple Summary: When evaluating new cancer therapies in clinical trials, it may take a long time to estimate their effectiveness on overall survival, an outcome typically of main interest to regulatory decision-makers. To expedite access to new therapies for patients, regulatory agencies often make their decisions based on treatment effectiveness measured on surrogate outcomes; for example looking at the impact of treatment on delaying cancer recurrence, which can be measured earlier. For such decisions to be robust, a surrogate endpoint needs to be a valid predictor of overall survival. The validation can be complex and previous research in advanced colorectal cancer has suggested that the validity of a surrogate endpoint may depend on treatment class. We have investigated this and our results indicated that the validity of surrogate endpoints is stronger within some treatment classes compared to when ignoring the treatment class. Surrogate's validity needs careful consideration to ensure appropriate regulatory decisions. Background and Aim: Findings from the literature suggest that the validity of surrogate endpoints in metastatic colorectal cancer (mCRC) may depend on a treatments' mechanism of action. We explore this and the impact of Kirsten rat sarcoma (KRAS) status on surrogacy patterns in mCRC. Methods: A systematic review was undertaken to identify randomized controlled trials (RCTs) for pharmacological therapies in mCRC. Bayesian meta-analytic methods for surrogate endpoint evaluation were used to evaluate surrogate relationships across all RCTs, by KRAS status and treatment class. Surrogate endpoints explored were progression free survival (PFS) as a surrogate endpoint for overall survival (OS), and tumour response (TR) as a surrogate for PFS and OS. Results: 66 RCTs were identified from the systematic review. PFS showed a strong surrogate relationship with OS across all data and in subgroups by KRAS status. The relationship appeared stronger within individual treatment classes compared to the overall analysis. The TR-PFS and TR-OS relationships were found to be weak overall but stronger within the Epidermal Growth Factor Receptor + Chemotherapy (EGFR + Chemo) treatment class; both overall and in the wild type (WT) patients for TR-PFS, but not in patients with the mutant (MT) KRAS status where data were limited. Conclusions: PFS appeared to be a good surrogate endpoint for OS. TR showed a moderate surrogate relationship with PFS and OS for the EGFR + Chemo treatment class. There was some evidence of impact of the mechanism of action on the strength of the surrogacy patterns in mCRC, but little evidence of the impact of KRAS status on the validity of surrogate endpoints. [ABSTRACT FROM AUTHOR]

Published
2022
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48. Using predictions from a joint model for longitudinal and survival data to inform the optimal time of intervention in an abdominal aortic aneurysm screening programme

Author

Sweeting, Michael J., Sweeting, Michael [0000-0003-0980-8965], and Apollo - University of Cambridge Repository

Subjects
Male, Risk, Biometry, Models, Statistical, Time Factors, Aortic Rupture, Survival Analysis, Decision Support Techniques, Joint Modeling of Longitudinal and Time‐to‐Event Data and Beyond, Elective Surgical Procedures, Disease Progression, Abdominal aortic aneurysm, Humans, Mass Screening, Personalised medicine, Longitudinal Studies, Dynamic predictions, Joint modelling, Decision making, Research Paper, Aged, Aortic Aneurysm, Abdominal
Abstract

Joint models of longitudinal and survival data can be used to predict the risk of a future event occurring based on the evolution of an endogenous biomarker measured repeatedly over time. This has led naturally to the use of dynamic predictions that update each time a new longitudinal measurement is provided. In this paper, we show how such predictions can be utilised within a fuller decision modelling framework, in particular to allow planning of future interventions for patients under a ‘watchful waiting’ care pathway. Through the objective of maximising expected life‐years, the predicted risks associated with not intervening (e.g. the occurrence of severe sequelae) are balanced against risks associated with the intervention (e.g. operative risks). Our example involves patients under surveillance in an abdominal aortic aneurysm screening programme where a joint longitudinal and survival model is used to associate longitudinal measurements of aortic diameter with the risk of aneurysm rupture. We illustrate how the decision to intervene, which is currently based on a diameter measurement greater than a certain threshold, could be made more personalised and dynamic through the application of a decision modelling approach.

Published
2017

50. Interleukin-6 Receptor Signaling and Abdominal Aortic Aneurysm Growth Rates

Author

Paige, Ellie, Clément, Marc, Lareyre, Fabien, Sweeting, Michael, Raffort, Juliette, Grenier, Céline, Finigan, Alison, Harrison, James, Peters, James E, Sun, Benjamin B, Butterworth, Adam S, Harrison, Seamus C, Bown, Matthew J, Lindholt, Jes S, Badger, Stephen A, Kullo, Iftikhar J, Powell, Janet, Norman, Paul E, Scott, D Julian A, Bailey, Marc A, Rose-John, Stefan, Danesh, John, Freitag, Daniel F, Paul, Dirk S, Mallat, Ziad, Sweeting, Michael [0000-0003-0980-8965], Harrison, James [0000-0003-4960-5062], Sun, Ben [0000-0001-6347-2281], Butterworth, Adam [0000-0002-6915-9015], Harrison, Seamus Conor [0000-0003-1480-1143], Danesh, John [0000-0003-1158-6791], Paul, Dirk [0000-0002-8230-0116], Mallat, Ziad [0000-0003-0443-7878], and Apollo - University of Cambridge Repository

Subjects
Polymorphism, Single Nucleotide, Antibodies, Mice, Transforming Growth Factor beta, Animals, Humans, genetics, Interleukin-6, Angiotensin II, Original Articles, Receptors, Interleukin-6, Survival Rate, Disease Models, Animal, interleukins, inflammation, alleles, ComputingMethodologies_DOCUMENTANDTEXTPROCESSING, Linear Models, cardiovascular system, aortic aneurysm, Biomarkers, Aortic Aneurysm, Abdominal, Signal Transduction
Abstract

Supplemental Digital Content is available in the text., Background: The Asp358Ala variant (rs2228145; A>C) in the IL (interleukin)-6 receptor (IL6R) gene has been implicated in the development of abdominal aortic aneurysms (AAAs), but its effect on AAA growth over time is not known. We aimed to investigate the clinical association between the IL6R-Asp358Ala variant and AAA growth and to assess the effect of blocking the IL-6 signaling pathway in mouse models of aortic aneurysm rupture or dissection. Methods: Using data from 2863 participants with AAA from 9 prospective cohorts, age- and sex-adjusted mixed-effects linear regression models were used to estimate the association between the IL6R-Asp358Ala variant and annual change in AAA diameter (mm/y). In a series of complementary randomized trials in mice, the effect of blocking the IL-6 signaling pathways was assessed on plasma biomarkers, systolic blood pressure, aneurysm diameter, and time to aortic rupture and death. Results: After adjusting for age and sex, baseline aneurysm size was 0.55 mm (95% CI, 0.13–0.98 mm) smaller per copy of the minor allele [C] of the Asp358Ala variant. Change in AAA growth was −0.06 mm per year (−0.18 to 0.06) per copy of the minor allele; a result that was not statistically significant. Although all available worldwide data were used, the genetic analyses were not powered for an effect size as small as that observed. In 2 mouse models of AAA, selective blockage of the IL-6 trans-signaling pathway, but not combined blockage of both, the classical and trans-signaling pathways, was associated with improved survival (P

Published
2019
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