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1. Canadian Surgery Forum 2018: St. John’s, NL Sept. 13–15, 2018

Author

S, Jayaraman, L, Lee, J, Mata, R, Droeser, P, Kaneva, S, Liberman, P, Charlebois, B, Stein, G, Fried, L, Feldman, M, Schellenberg, K, Inaba, V, Cheng, J, Bardes, L, Lam, E, Benjamin, K, Matsushima, D, Demetriades, J, Cho, A, Strumwasser, D, Grabo, C, Bir, A, Eastman, N, Orozco, J, Chen, C, Park, T, Kang, J, Jung, J, Elfassy, T, Grantcharov, J, Taylor, M, Stem, D, Yu, S, Chen, S, Fang, S, Gearhart, B, Safar, J, Efron, P, Serrano, S, Parpia, D, McCarty, N, Solis, M, Valencia, S, Jibrael, A, Wei, S, Gallinger, M, Simunovic, A, Hummadi, M, Rabie, M, Al Skaini, H, Shamshad, S, Shah, K, Verhoeff, P, Glen, A, Taheri, B, Min, B, Tsang, V, Fawcett, S, Widder, M, Yang, K, Wanis, O, Gilani, K, Vogt, M, Ott, J, VanKoughnett, C, Vinden, S, Balvardi, E, St Louis, Y, Yousef, A, Toobaie, E, Guadagno, R, Baird, D, Poenaru, A, Kleiman, B, Mador, C, Moulton, E, Lee, C, Li, K, Beyfuss, H, Solomon, N, Sela, V, McAlister, A, Ritter, J, Hallet, M, Tsang, G, Martel, D, Jalink, M, Husien, C, Gu, M, Levine, S, Otiti, J, Nginyangi, C, Yeo, J, Ring, M, Holden, T, Ungi, G, Fichtinger, B, Zevin, B, Fang, J, Dang, S, Karmali, M, Kim, B, Zhang, E, Duceppe, S, Rieder, A, Maeda, A, Okrainec, T, Jackson, F, Kegel, S, Lachance, T, Landry, C, Mueller, S, Joharifard, E, Nyiemah, C, Howe, C, Dobboh, L Gizzie, Kortimai, A, Kabeto, J, Beste, N, Garraway, R, Riviello, S, Hameed, S, Shinde, G, Marcil, S, Prasad, J, Arminan, E, Debru, N, Church, R, Gill, P, Mitchell, M, Delisle, C, Chernos, J, Park, K, Hardy, A, Vergis, M, Guez, D, Hong, J, Koichopolos, R, Hilsden, D, Thompson, F, Myslik, J, Vandeline, R, Leeper, A, Doumouras, S, Govind, S, Valanci, N, Alhassan, T, Wong, N, Nadkarni, S, Chia, D, Seow, D, Carter, L, Ruo, O, Levine, L, Allen, P, Murphy, R, van Heest, F, Saleh, S, Minor, P, Engels, E, Joos, C, Wang, R, Nenshi, M, Meschino, C, Laane, N, Parry, M, Hameed, A, Lacoul, C, Chrystoja, J, Ramjist, R, Sutradhar, L, Lix, N, Baxter, D, Urbach, J, Ahlin, S, Patel, S, Nanji, S, Merchant, K, Lajkosz, S, Brogly, P, Groome, J, Sutherland, G, Liu, T, Crump, M, Bair, A, Karimuddin, A, Peterson, J, Hawel, E, Shlomovitz, I, Habaz, A, Elnahas, N, Alkhamesi, C, Schlachta, G, Akhtar-Danesh, T, Daodu, V, Nguyen, R, Dearden, I, Datta, L, Hampton, A, Kirkpatrick, J, McKee, J, Regehr, P, Brindley, D, Martin, A, LaPorta, L, Gillman, K, DeGirolamo, K, D'Souza, L, Hartford, D, Gray, C, Clarke, R, Wigen, C, Garcia-Ochoa, S, Gray, A, Maciver, J, Van Koughnett, K, Leslie, T, Zwiep, S, Ahn, J, Greenberg, F, Balaa, D, McIsaac, R, Musselman, I, Raiche, L, Williams, H, Moloo, M, Nguyen, D, Naidu, P, Karanicolas, A, Nadler, R, Raskin, V, Khokhotva, R, Poirier, C, Plourde, A, Paré, M, Marchand, M, Leclair, J, Deshaies, P, Hebbard, I, Ratnayake, K, Decker, E, MacIntosh, Z, Najarali, A, Alhusaini, A, McClure, M, Dakouo, R, Behman, A, Nathens, N Look, Hong, P, Pechlivanoglou, K, Lung, P, Simone, E, Schemitsch, L, Chen, L, Rosenkrantz, N, Schuurman, R, George, E, Shavit, A, Pawliwec, Z, Rana, D, Evans, P, Dawe, R, Brown, G, Lefebvre, K, Devenny, D, Héroux, C, Bowman, R, Mimeault, L, Calder, L, Baker, R, Winter, C, Cahill, D, Fergusson, T, Schroeder, K, Kahnamoui, S, Elkheir, F, Farrokhyar, B, Wainman, O, Hershorn, S, Lim, A, Arora, F, Wright, J, Escallon, L, Gotlib, M, Allen, N, Gawad, I, Raîche, G, Jeyakumar, D, Li, M, Aarts, A, Giles, T, Dumitra, R, Alam, J, Fiore, M, Vassiliou, O, Al Busaidi, A, Brobbey, T, Stelfox, T, Chowdhury, J, Kortbeek, C, Ball, N, AlShahwan, S, Fraser, A, Tran, A, Martel, N, Manhas, D, Mannina, A, Behman, B, Haas, A, Fowler, L, Findlay-Shirras, H, Singh, N, Biswanger, A, Gosselin-Tardif, M Abou, Khalil, J Mata, Gutierrez, A, Guigui, L, Ferri, D, Roberts, L, Moore, J, Holcomb, J, Harvin, J, Sadek, P, Belanger, K, Nadeau, K, Mullen, D, Aitkens, K, Foss, D, MacIsaac, S, Zhang, M, Methot, L, Hookey, J, Yates, I, Perelman, E, Saidenberg, S, Khair, J, Lampron, A, Tinmouth, S, Hammond, D, Hochman, M, Lê, R, Rabbani, A, Abou-Setta, R, Zarychanski, B, Elsoh, B, Goldacre, G, Nash, M, Trepanier, N, Wong-Chong, C, Sabapathy, P, Chaudhury, N, Bradley, C, Dakin, N, Holm, W, Henderson, M, Roche, A, Sawka, E, Tang, B, Huang, T, Gimon, R, Rochon, M, Lipson, W, Buie, A, MacLean, E, Lau, V, Mocanu, I, Tavakoli, N, Switzer, C, Tian, C, de Gara, D, Birch, P, Young, C, Chiu, A, Meneghetti, G, Warnock, M, Meloche, O, Panton, A, Istl, A, Gan, P, Colquhoun, R, Habashi, S, Stogryn, J, Metcalfe, K, Clouston, N, Zondervan, K, McLaughlin, J, Springer, J, Lee, N, Amin, M, Caddedu, C, Eskicioglu, A, Warraich, D, Keren, N, Kloos, S, Gregg, R, Mohamed, E, Dixon, R, Rochan, A, Domouras, S, Kelly, I, Yang, S, Forbes, R, Garfinkle, S, Bhatnagar, G, Ghitulescu, C, Vasilevsky, N, Morin, M, Boutros, A, Petrucci, P, Sylla, S, Wexner, G, Sigler, J, Faria, P, Gordon, L, Azoulay, A, Liberman, S, Khorasani, A, de Buck van Overstraeten, E, Kennedy, N, Pecorelli, D, Mouldoveanu, A, Gosselin-Tardiff, J, Chau, F Rouleau, Fournier, P, Bouchard, J Abou, Khalil, J, Motter, J, Mottl, G, Hwang, J, Kelly, G, Nassif, M, Albert, J, Monson, J, McLeod, J, Cha, M, Raval, T, Phang, C, Brown, R, Robertson, F, Letarte, A, Antoun, V, Pelsser, E, Hyun, K, Clouston-Chambers, R, Helewa, S, Candy, Z, Mir, N, Hanna, A, Azin, D, Hirpara, F, Quereshy, C, O'Brien, S, Chadi, S, Punnen, H, Yoon, W, Xiong, H, Stuart, J, Andrews, R, Selvam, S, Wong, W, Hopman, P, MacDonald, F, Dossa, B, Medeiros, C, Keng, S, Acuna, J, Hamid, A, Ghuman, N, Kasteel, D, Buie, T, McMullen, A, Elwi, T, MacLean, H, Wang, F, Coutinho, Q, Le, L, Shack, H, Roy, R, Kennedy, J, Bunn, W, Chung, M, Elmi, E, Wakeam, R, Presutti, S, Keshavjee, T, Cil, D, McCready, V, Cheung, C, Schieman, J, Bailey, G, Nelson, T, Batchelor, S, Grondin, A, Graham, N, Safieddine, S, Johnson, W, Hanna, D, Low, A, Seely, E, Bedard, C, Finley, R, Nayak, D, Lougheed, D, Petsikas, A, Kinio, V Ferreira, Resende, C, Anstee, D, Maziak, S, Gilbert, F, Shamji, S, Sundaresan, P, Villeneuve, J, Ojah, A, Ashrafi, A, Najjar, I, Yamani, S, Sersar, A, Batouk, D, Parente, A, Laliberte, M, McInnis, C, McDonald, Y, Hasnain, K, Yasufuku, T, Waddell, N, Chopra, C, Nicholson-Smith, R, Malthaner, R, Patel, M, Doubova, H, Robaidi, E, Delic, A, Fazekas, K, Hughes, P, Pinkney, Y, Lopez-Hernandez, M, Coret, L, Schneider, J, Agzarian, Y, Shargall, M, Mehta, K, Pearce, V, Gupta, N, Coburn, B, Kidane, K, Hess, C, Compton, J, Ringash, G, Darling, A, Mahar, P, Thomas, J, Vernon, J, Spicer, S, Renaud, J, Seitlinger, Y, Al Lawati, F, Guerrera, P, Falcoz, G, Massard, D, Hylton, J, Huang, S, Turner, D, French, C, Wen, J, Masters, C, Fahim, D, St-Pierre, E, Ruffini, M, Inra, Z, Abdelsattar, S, Cassivi, F, Nichols, D, Wigle, S, Blackmon, K, Shen, S, Gowing, F Sadegh, Beigee, K, Sheikhy, A Abbasi, Dezfouli, T, Schnurr, L, Linkins, M, Crowther, M, de Perrot, S, Uddin, J, Douketis, L, Angka, A, Jeong, M, Sadiq, M, Kilgour, C Tanese, de Souza, M, Kennedy, R, Auer, R, Adam, R, Memeo, D, Goéré, T, Piardi, E, Lermite, O, Turrini, M, Lemke, J, Li, M, Tun-Abraham, R, Hernandez-Alejandro, S, Bennett, F, Navarro, A, Sa Cunha, P, Pessaux, E, Isenberg-Grzeda, J, Kazdan, S, Myrehaug, S, Singh, D, Chan, C, Law, C, Nessim, G, Paull, A, Ibrahim, E, Sabri, S, Rodriguez-Qizilbash, D, Berger-Richardson, R, Younan, J, Hétu, S, Johnson-Obaseki, F, Angarita, Y, Zhang, A, Govindarajan, E, Taylor, Z, Bayat, D, Bischof, A, McCart, S, Sequeira, S, Samman, S, Cornacchi, G, Foster, L, Thabane, S, Thomson, O, Lovrics, S, Martin, P, Lovrics, N, Latchana, L, Davis, Y, Liu, A, Hammad, D, Kagedan, C, Earle, G, Pang, S, Kupper, M, Quan, R, Hsiao, P, Bongers, M, Lustgarten, D, Goldstein, P, Dhar, L, Rotstein, J, Pasternak, J, Nostedt, L, Gibson-Brokop, M, McCall, D, Schiller, S, Mukhi, L, Mack, N, Singh, M, Chanco, A, Hilchie-Pye, C, Kenyon, A, Mathieson, J, Burke, R, Nason, J, Austin, M, Brar, S, Hurton, S, Kong, Y, Xu, M, Thibedeau, W, Cheung, J, Dort, S, Karim, A, Bouchard-Fortier, Y, Jeong, Q, Li, L, Bubis, C, O'Rourke, N, Dharampal, K, Smith, A, Harvey, R, Pashcke, L, Rudmik, S, Chandarana, S, Buac, S, Latosinsky, N, Shahvary, M, Gervais, G, Leblanc, M, Brackstone, K, Guidolin, B, Yaremko, S, Gaede, K, Lynn, A, Kornecki, G, Muscedere, O, Shmuilovich, I, BenNachum, M, Mouawad, N, Gelman, M, Lock, J, Daza, M, Horkoff, F, Sutherland, O, Bathe, M, Moser, J, Shaw, G, Beck, Y, Luo, S, Ahmed, C, Wall, T, Domes, K, Jana, E, Waugh, J, Baird, P, Newell, P, Hansen, M, Gough, E, McArthur, A, Skaro, G, Gauvin, N, Goel, D, Mutabdzic, F, Lambreton, M, Kilcoyne, K, Ang, A, Karachristos, H, Cooper, J, Hoffman, S, Reddy, L, Park, R, Gilbert, R, Shorr, A, Workneh, K, Bertens, J, Abou-Khalil, H, Smith, J, Levy, J, Ellis, B, Bakanisi, M, Sadeghi, S, Michaelson, V, Tandan, M, Marcaccio, D, Dath, M, Connell, A, Bennett, N, Wasey, R, Sorial, S, Macdonald, D, Johnson, D, Klassen, C, Leung, C, Botkin, M, Bahasadri, S, MacLellan, J, Tan, H, Jun, H, Cheah, K, Wong, N, Harvey, A, Smith, S, Cassie, S, Sun, J, Vallis, L, Twells, K, Lester, D, Gregory, W, Sun, F, Raghavji, M, Laffin, J, Bourget-Murray, A, Reso, A, Jarrar, N, Eipe, A, Budiansky, C, Walsh, J, Mamazza, and M, Rashid

Subjects
Abstracts
Published
2018

2. Exploring human factors in the operating room: scoping review of training offerings for healthcare professionals.

Author

Lee A, Finstad A, Tipney B, Lamb T, Rahman A, Devenny K, Abou Khalil J, Kuziemsky C, and Balaa F

Subjects
Clinical Competence, Delivery of Health Care, Humans, Patient Safety, Operating Rooms, Surgeons
Abstract

Background: Human factors (HF) integration can improve patient safety in the operating room (OR), but the depth of current knowledge remains unknown. This study aimed to explore the content of HF training for the operative environment., Methods: We searched six bibliographic databases for studies describing HF interventions for the OR. Skills taught were classified using the Chartered Institute of Ergonomics and Human Factors (CIEHF) framework, consisting of 67 knowledge areas belonging to five categories: psychology; people and systems; methods and tools; anatomy and physiology; and work environment., Results: Of 1851 results, 28 studies were included, representing 27 unique interventions. HF training was mostly delivered to interdisciplinary groups (n = 19; 70 per cent) of surgeons (n = 16; 59 per cent), nurses (n = 15; 56 per cent), and postgraduate surgical trainees (n = 11; 41 per cent). Interactive methods (multimedia, simulation) were used for teaching in all studies. Of the CIEHF knowledge areas, all 27 interventions taught 'behaviours and attitudes' (psychology) and 'team work' (people and systems). Other skills included 'communication' (n = 25; 93 per cent), 'situation awareness' (n = 23; 85 per cent), and 'leadership' (n = 20; 74 per cent). Anatomy and physiology were taught by one intervention, while none taught knowledge areas under work environment., Conclusion: Expanding HF education requires a broader inclusion of the entirety of sociotechnical factors such as contributions of the work environment, technology, and broader organizational culture on OR safety to a wider range of stakeholders., (© The Author(s) 2022. Published by Oxford University Press on behalf of BJS Society Ltd.)

Published
2022
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3. Exploring human factors in the operating room: a protocol for a scoping review of training offerings for healthcare professionals.

Author

Lee A, Tipney B, Finstad A, Rahman A, Devenny K, Abou Khalil J, Kuziemsky C, and Balaa F

Subjects
Humans, Peer Review, Research Design, Review Literature as Topic, Systematic Reviews as Topic, Delivery of Health Care, Operating Rooms
Abstract

Introduction: Applying human factors principles in surgical care has potential benefits for patient safety and care delivery. Although different theoretical frameworks of human factors exist, how providers are being trained in human factors and how human factors are being understood in vivo in the operating room (OR) remain unknown. The aim of this scoping review is to evaluate the application of human factors for the OR environment as described by education and training offerings for healthcare professionals., Methods and Analysis: This scoping review will follow the Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews guidelines. MEDLINE, Embase, PsycINFO, CINAHL, Health and Psychosocial Instruments and ERIC databases were searched on August 2020 from inception to identify relevant studies that describe the content, application and impact of human factors training for healthcare professionals or trainees who work in or interface with the OR environment. Titles, abstracts and full texts will be independently screened by two authors for eligible studies. Any disagreements will be resolved by discussion or by a third author when disagreement persists. Study information and training characteristics, such as the training tool used and type of learners and teachers, will be charted and summarised, and key themes in human factors training will be identified. Each training offering will be classified under the appropriate knowledge area(s) of human factors described by the Chartered Institute of Ergonomics & Human Factors (CIEHF). Themes that are not captured by the CIEHF framework will be independently recorded by two authors and included based on group discussion and consensus., Ethics and Dissemination: Research ethics board approval is not required for this scoping review. The findings of this study will be disseminated at local and national conferences and will be published in a peer-reviewed journal., Competing Interests: Competing interests: FB is the Director at Saegis, a subsidiary of the Canadian Medical Protective Association. KD is the Programme Lead at Saegis. BT is the Founder and Managing Director at MedLed Ltd., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Published
2021
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4. Using medicolegal data to support safe medical care: A contributing factor coding framework.

Author

McCleery A, Devenny K, Ogilby C, Dunn C, Steen A, Whyte E, Darling R, VanderHoek R, MacIntyre A, Carpenter S, Wallace G, and Calder L

Subjects
Clinical Coding statistics & numerical data, Humans, Medical Records statistics & numerical data, Patient Safety statistics & numerical data, Clinical Coding standards, Data Accuracy, Medical Records standards, Patient Safety standards, Risk Management methods
Abstract

Objective: Traditional medicolegal data analysis focuses on physician care, without a full acknowledgment of the effects of team, organizational, and system factors. We developed a patient safety-informed contributing factor framework to strengthen the coding and analysis of medicolegal data., Materials and Methods: We incorporated patient safety theory and human factors science into our medicolegal case coding practices to improve our understanding of the many factors that contribute to medicolegal events., Results and Discussion: A new framework was developed that has at its core, patients and their experience, and looks beyond the provider factors that are often the focus of medicolegal analysis to give greater consideration to the influence of team, organizational, and system factors. We anticipate that this substantial shift will strengthen our knowledge translation efforts to help improve the safety of medical care., Conclusion: We believe that reframing medicolegal case coding systems to better identify the influence of team, organizational, and system factors will increase the utility of this analysis in patient safety research, and health care quality improvement., (© 2018 American Society for Health Care Risk Management of the American Hospital Association.)

Published
2019
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5. Canadian Surgery Forum 2018: St. John's, NL Sept. 13-15, 2018.

Author

Jayaraman S, Lee L, Mata J, Droeser R, Kaneva P, Liberman S, Charlebois P, Stein B, Fried G, Feldman L, Schellenberg M, Inaba K, Cheng V, Bardes J, Lam L, Benjamin E, Matsushima K, Demetriades D, Schellenberg M, Inaba K, Cho J, Strumwasser A, Grabo D, Bir C, Eastman A, Demetriades D, Schellenberg M, Inaba K, Bardes J, Orozco N, Chen J, Park C, Kang T, Demetriades D, Jung J, Elfassy J, Grantcharov T, Jung J, Grantcharov T, Jung J, Grantcharov T, Taylor J, Stem M, Yu D, Chen S, Fang S, Gearhart S, Safar B, Efron J, Serrano P, Parpia S, McCarty D, Solis N, Valencia M, Jibrael S, Wei A, Gallinger S, Simunovic M, Hummadi A, Rabie M, Al Skaini M, Shamshad H, Shah S, Verhoeff K, Glen P, Taheri A, Min B, Tsang B, Fawcett V, Widder S, Yang M, Wanis K, Gilani O, Vogt K, Ott M, VanKoughnett J, Vinden C, Balvardi S, St Louis E, Yousef Y, Toobaie A, Guadagno E, Baird R, Poenaru D, Kleiman A, Mador B, Widder S, Serrano P, Moulton C, Lee E, Li C, Beyfuss K, Solomon H, Sela N, McAlister V, Ritter A, Gallinger S, Hallet J, Tsang M, Martel G, Jalink D, Husien M, Gu C, Levine M, Otiti S, Nginyangi J, Yeo C, Ring J, Holden M, Ungi T, Fichtinger G, Zevin B, Fang B, Dang J, Karmali S, Serrano P, Kim M, Zhang B, Duceppe E, Rieder S, Maeda A, Okrainec A, Jackson T, Kegel F, Lachance S, Landry T, Feldman L, Fried G, Mueller C, Lee L, Kegel F, Kegel F, Lachance S, Lee L, Joharifard S, Nyiemah E, Howe C, Dobboh C, Kortimai LG, Kabeto A, Beste J, Garraway N, Riviello R, Hameed S, Shinde S, Marcil G, Prasad S, Arminan J, Debru E, Church N, Gill R, Mitchell P, Delisle M, Chernos C, Park J, Hardy K, Vergis A, Guez M, Hong D, Guez M, Hong D, Koichopolos J, Hilsden R, Thompson D, Myslik F, Vandeline J, Leeper R, Doumouras A, Govind S, Hong D, Govind S, Valanci S, Alhassan N, Lee L, Feldman L, Fried G, Mueller C, Wong T, Nadkarni N, Chia S, Seow D, Carter D, Li C, Valencia M, Ruo L, Parpia S, Simunovic M, Levine O, Serrano P, Vogt K, Allen L, Murphy P, van Heest R, Saleh F, Widder S, Minor S, Engels P, Joos E, Wang C, Nenshi R, Meschino M, Laane C, Parry N, Hameed M, Lacoul A, Lee L, Chrystoja C, Ramjist J, Sutradhar R, Lix L, Simunovic M, Baxter N, Urbach D, Ahlin J, Patel S, Nanji S, Merchant S, Lajkosz K, Brogly S, Groome P, Sutherland J, Liu G, Crump T, Bair M, Karimuddin A, Sutherland J, Peterson A, Karimuddin A, Liu G, Crump T, Koichopolos J, Hawel J, Shlomovitz E, Habaz I, Elnahas A, Alkhamesi N, Schlachta C, Akhtar-Danesh G, Doumouras A, Hong D, Daodu T, Nguyen V, Dearden R, Datta I, Hampton L, Kirkpatrick A, McKee J, Regehr J, Brindley P, Martin D, LaPorta A, Park J, Vergis A, Gillman L, DeGirolamo K, Hameed M, D'Souza K, Hartford L, Gray D, Murphy P, Hilsden R, Clarke C, Vogt K, Wigen R, Allen L, Garcia-Ochoa C, Gray S, Maciver A, Parry N, Van Koughnett J, Leslie K, Zwiep T, Ahn S, Greenberg J, Balaa F, McIsaac D, Musselman R, Raiche I, Williams L, Moloo H, Nguyen M, Naidu D, Karanicolas P, Nadler A, Raskin R, Khokhotva V, Poirier R, Plourde C, Paré A, Marchand M, Leclair M, Deshaies J, Hebbard P, Ratnayake I, Decker K, MacIntosh E, Najarali Z, Valencia M, Zhang B, Alhusaini A, Solis N, Duceppe E, Parpia S, Ruo L, Simunovic M, Serrano P, Murphy P, Murphy P, McClure A, Dakouo M, Vogt K, Vinden C, Behman R, Nathens A, Hong NL, Pechlivanoglou P, Karanicolas P, Lung K, Leslie K, Parry N, Vogt K, Leeper R, Simone P, Leslie K, Schemitsch E, Laane C, Chen L, Rosenkrantz L, Schuurman N, Hameed M, Joos E, George R, Shavit E, Pawliwec A, Rana Z, Laane C, Joos E, Evans D, Dawe P, Brown R, Hameed M, Lefebvre G, Devenny K, Héroux D, Bowman C, Mimeault R, Calder L, Baker L, Winter R, Cahill C, Fergusson D, Williams L, Schroeder T, Kahnamoui K, Elkheir S, Farrokhyar F, Wainman B, Hershorn O, Lim S, Hardy K, Vergis A, Arora A, Wright F, Nadler A, Escallon J, Gotlib L, Allen M, Gawad N, Raîche I, Jeyakumar G, Li D, Aarts M, Meschino M, Giles A, Dumitra T, Alam R, Fiore J, Mata J, Fried G, Vassiliou M, Mueller C, Lee L, Feldman L, Al Busaidi O, Brobbey A, Stelfox T, Chowdhury T, Kortbeek J, Ball C, AlShahwan N, Fraser S, Gawad N, Tran A, Martel A, Baxter N, Allen M, Manhas N, Balaa F, Mannina D, Khokhotva V, Tran A, Gawad N, Martel A, Manhas N, Allen M, Balaa F, Behman R, Behman A, Haas B, Hong NL, Pechlivanoglou P, Karanicolas P, Gawad N, Fowler A, Mimeault R, Raiche I, Findlay-Shirras L, Decker K, Singh H, Biswanger N, Park J, Gosselin-Tardif A, Khalil MA, Gutierrez JM, Guigui A, Feldman L, Lee L, Mueller C, Ferri L, Roberts D, Stelfox T, Moore L, Holcomb J, Harvin J, Sadek J, Belanger P, Nadeau K, Mullen K, Aitkens D, Foss K, MacIsaac D, Williams L, Musselman R, Raiche I, Moloo H, Zhang S, Ring J, Methot M, Zevin B, Yu D, Hookey L, Patel S, Yates J, Perelman I, Saidenberg E, Khair S, Taylor J, Lampron J, Tinmouth A, Lim S, Hammond S, Park J, Hochman D, Lê M, Rabbani R, Abou-Setta A, Zarychanski R, Patel S, Yu D, Elsoh B, Goldacre B, Nash G, Trepanier M, Alhassan N, Wong-Chong N, Sabapathy C, Chaudhury P, Liberman S, Charlebois P, Stein B, 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Published
2018
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6. Dabigatran versus warfarin in patients with mechanical heart valves.

Author

Eikelboom JW, Connolly SJ, Brueckmann M, Granger CB, Kappetein AP, Mack MJ, Blatchford J, Devenny K, Friedman J, Guiver K, Harper R, Khder Y, Lobmeyer MT, Maas H, Voigt JU, Simoons ML, and Van de Werf F

Subjects
Aged, Anticoagulants adverse effects, Benzimidazoles adverse effects, Dabigatran, Female, Hemorrhage chemically induced, Humans, Male, Middle Aged, Thromboembolism chemically induced, Warfarin adverse effects, beta-Alanine administration & dosage, beta-Alanine adverse effects, Anticoagulants administration & dosage, Atrial Fibrillation drug therapy, Benzimidazoles administration & dosage, Heart Valve Prosthesis, Stroke prevention & control, Thromboembolism prevention & control, Warfarin administration & dosage, beta-Alanine analogs & derivatives
Abstract

Background: Dabigatran is an oral direct thrombin inhibitor that has been shown to be an effective alternative to warfarin in patients with atrial fibrillation. We evaluated the use of dabigatran in patients with mechanical heart valves., Methods: In this phase 2 dose-validation study, we studied two populations of patients: those who had undergone aortic- or mitral-valve replacement within the past 7 days and those who had undergone such replacement at least 3 months earlier. Patients were randomly assigned in a 2:1 ratio to receive either dabigatran or warfarin. The selection of the initial dabigatran dose (150, 220, or 300 mg twice daily) was based on kidney function. Doses were adjusted to obtain a trough plasma level of at least 50 ng per milliliter. The warfarin dose was adjusted to obtain an international normalized ratio of 2 to 3 or 2.5 to 3.5 on the basis of thromboembolic risk. The primary end point was the trough plasma level of dabigatran., Results: The trial was terminated prematurely after the enrollment of 252 patients because of an excess of thromboembolic and bleeding events among patients in the dabigatran group. In the as-treated analysis, dose adjustment or discontinuation of dabigatran was required in 52 of 162 patients (32%). Ischemic or unspecified stroke occurred in 9 patients (5%) in the dabigatran group and in no patients in the warfarin group; major bleeding occurred in 7 patients (4%) and 2 patients (2%), respectively. All patients with major bleeding had pericardial bleeding., Conclusions: The use of dabigatran in patients with mechanical heart valves was associated with increased rates of thromboembolic and bleeding complications, as compared with warfarin, thus showing no benefit and an excess risk. (Funded by Boehringer Ingelheim; ClinicalTrials.gov numbers, NCT01452347 and NCT01505881.).

Published
2013
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