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2. Effect of Convalescent Plasma on Organ Support-Free Days in Critically Ill Patients With COVID-19: A Randomized Clinical Trial

Author

Estcourt, L.J., Turgeon, A.F., McQuilten, Z.K., McVerry, B.J., Al-Beidh, F., Annane, D., Arabi, Y.M., Arnold, D.M., Beane, A., Bégin, P., Bentum-Puijk, W. van, Berry, L.R., Bhimani, Z., Birchall, J.E., Bonten, M.J.M., Bradbury, C.A., Brunkhorst, F.M., Buxton, M., Callum, J.L., Chassé, M., Cheng, A.C., Cove, M.E., Daly, J., Derde, L., Detry, M.A., Jong, Menno de, Evans, A., Fergusson, D.A., Fish, M., Fitzgerald, M., Foley, C., Goossens, H., Gordon, A.C., Gosbell, I.B., Green, C., Haniffa, R., Harvala, H., Higgins, A.M., Hills, T.E., Hoad, V.C., Horvat, C., Huang, D.T., Hudson, C.L., Ichihara, N., Laing, E., Lamikanra, A.A., Lamontagne, F., Lawler, P.R., Linstrum, K., Litton, E., Lorenzi, E., MacLennan, S., Marshall, J., McAuley, D.F., McDyer, J.F., McGlothlin, A., McGuinness, S., Miflin, G., Montgomery, S., Mouncey, P.R., Murthy, S., Nichol, A., Parke, R., Parker, J.C., Priddee, N., Purcell, D.F.J., Reyes, L.F., Richardson, P., Robitaille, N., Rowan, K.M., Rynne, J., Saito, H., Santos, M., Saunders, C.T., Neto, A. Serpa, Seymour, C.W., Silversides, J.A., Tinmouth, A.A., Triulzi, D.J., Turner, A.M., Veerdonk, F.L. van de, Walsh, T.S., Wood, E.M., Berry, S., Lewis, R.J., Menon, D.K., McArthur, C., Zarychanski, R., Angus, D.C., Webb, S.A., Roberts, D.J., Shankar-Hari, M., Estcourt, L.J., Turgeon, A.F., McQuilten, Z.K., McVerry, B.J., Al-Beidh, F., Annane, D., Arabi, Y.M., Arnold, D.M., Beane, A., Bégin, P., Bentum-Puijk, W. van, Berry, L.R., Bhimani, Z., Birchall, J.E., Bonten, M.J.M., Bradbury, C.A., Brunkhorst, F.M., Buxton, M., Callum, J.L., Chassé, M., Cheng, A.C., Cove, M.E., Daly, J., Derde, L., Detry, M.A., Jong, Menno de, Evans, A., Fergusson, D.A., Fish, M., Fitzgerald, M., Foley, C., Goossens, H., Gordon, A.C., Gosbell, I.B., Green, C., Haniffa, R., Harvala, H., Higgins, A.M., Hills, T.E., Hoad, V.C., Horvat, C., Huang, D.T., Hudson, C.L., Ichihara, N., Laing, E., Lamikanra, A.A., Lamontagne, F., Lawler, P.R., Linstrum, K., Litton, E., Lorenzi, E., MacLennan, S., Marshall, J., McAuley, D.F., McDyer, J.F., McGlothlin, A., McGuinness, S., Miflin, G., Montgomery, S., Mouncey, P.R., Murthy, S., Nichol, A., Parke, R., Parker, J.C., Priddee, N., Purcell, D.F.J., Reyes, L.F., Richardson, P., Robitaille, N., Rowan, K.M., Rynne, J., Saito, H., Santos, M., Saunders, C.T., Neto, A. Serpa, Seymour, C.W., Silversides, J.A., Tinmouth, A.A., Triulzi, D.J., Turner, A.M., Veerdonk, F.L. van de, Walsh, T.S., Wood, E.M., Berry, S., Lewis, R.J., Menon, D.K., McArthur, C., Zarychanski, R., Angus, D.C., Webb, S.A., Roberts, D.J., and Shankar-Hari, M.

Abstract

Item does not contain fulltext, IMPORTANCE: The evidence for benefit of convalescent plasma for critically ill patients with COVID-19 is inconclusive. OBJECTIVE: To determine whether convalescent plasma would improve outcomes for critically ill adults with COVID-19. DESIGN, SETTING, AND PARTICIPANTS: The ongoing Randomized, Embedded, Multifactorial, Adaptive Platform Trial for Community-Acquired Pneumonia (REMAP-CAP) enrolled and randomized 4763 adults with suspected or confirmed COVID-19 between March 9, 2020, and January 18, 2021, within at least 1 domain; 2011 critically ill adults were randomized to open-label interventions in the immunoglobulin domain at 129 sites in 4 countries. Follow-up ended on April 19, 2021. INTERVENTIONS: The immunoglobulin domain randomized participants to receive 2 units of high-titer, ABO-compatible convalescent plasma (total volume of 550 mL ± 150 mL) within 48 hours of randomization (n = 1084) or no convalescent plasma (n = 916). MAIN OUTCOMES AND MEASURES: The primary ordinal end point was organ support-free days (days alive and free of intensive care unit-based organ support) up to day 21 (range, -1 to 21 days; patients who died were assigned -1 day). The primary analysis was an adjusted bayesian cumulative logistic model. Superiority was defined as the posterior probability of an odds ratio (OR) greater than 1 (threshold for trial conclusion of superiority >99%). Futility was defined as the posterior probability of an OR less than 1.2 (threshold for trial conclusion of futility >95%). An OR greater than 1 represented improved survival, more organ support-free days, or both. The prespecified secondary outcomes included in-hospital survival; 28-day survival; 90-day survival; respiratory support-free days; cardiovascular support-free days; progression to invasive mechanical ventilation, extracorporeal mechanical oxygenation, or death; intensive care unit length of stay; hospital length of stay; World Health Organization ordinal scale score at day 14; venous thromb

Published
2021

3. Therapeutic Anticoagulation with Heparin in Critically Ill Patients with Covid-19

Author

Goligher, E.C., Bradbury, C.A., McVerry, B.J., Lawler, P.R., Berger, J.S., Gong, M.N., Carrier, M., Reynolds, H.R., Kumar, A., Turgeon, A.F., Kornblith, L.Z., Kahn, S.R., Marshall, J.C., Kim, K.S., Houston, B.L., Derde, L.P.G., Cushman, M., Tritschler, T., Angus, D.C., Godoy, L.C., McQuilten, Z., Kirwan, B.A., Farkouh, M.E., Brooks, M.M., Lewis, R.J., Berry, L.R., Lorenzi, E., Gordon, A.C., Ahuja, T., Al-Beidh, F., Annane, D., Arabi, Y.M., Aryal, D., Kreuziger, L. Baumann, Beane, A., Bhimani, Z., Bihari, S., Billett, H.H., Bond, L., Bonten, M., Brunkhorst, F., Buxton, M., Buzgau, A., Castellucci, L.A., Chekuri, S., Chen, J.T., Cheng, A.C., Chkhikvadze, T., Coiffard, B., Contreras, A., Costantini, T.W., Brouwer, S., Detry, M.A., Duggal, A., Džavík, V., Effron, M.B., Eng, H.F., Escobedo, J., Estcourt, L.J., Everett, B.M., Fergusson, D.A., Fitzgerald, M., Fowler, R.A., Froess, J.D., Fu, Z., Galanaud, J.P., Galen, B.T., Gandotra, S., Girard, T.D., Goodman, A.L., Goossens, H., Green, C., Greenstein, Y.Y., Gross, P.L., Haniffa, R., Hegde, S.M., Hendrickson, C.M., Higgins, A.M., Hindenburg, A.A., Hope, A.A., Horowitz, J.M., Horvat, C.M., Huang, D.T., Hudock, K., Hunt, B.J., Husain, M., Hyzy, R.C., Jacobson, J.R., Jayakumar, D., Keller, N.M., Khan, A., Kim, Y., Kindzelski, A., King, A.J., Knudson, M.M., Kornblith, A.E., Kutcher, M.E., Laffan, M.A., Lamontagne, F., Gal, G. Le, Veerdonk, F.L. van de, Middeldorp, S., Schouten, J.A., Pickkers, P., Webb, S.A., Zarychanski, R., Goligher, E.C., Bradbury, C.A., McVerry, B.J., Lawler, P.R., Berger, J.S., Gong, M.N., Carrier, M., Reynolds, H.R., Kumar, A., Turgeon, A.F., Kornblith, L.Z., Kahn, S.R., Marshall, J.C., Kim, K.S., Houston, B.L., Derde, L.P.G., Cushman, M., Tritschler, T., Angus, D.C., Godoy, L.C., McQuilten, Z., Kirwan, B.A., Farkouh, M.E., Brooks, M.M., Lewis, R.J., Berry, L.R., Lorenzi, E., Gordon, A.C., Ahuja, T., Al-Beidh, F., Annane, D., Arabi, Y.M., Aryal, D., Kreuziger, L. Baumann, Beane, A., Bhimani, Z., Bihari, S., Billett, H.H., Bond, L., Bonten, M., Brunkhorst, F., Buxton, M., Buzgau, A., Castellucci, L.A., Chekuri, S., Chen, J.T., Cheng, A.C., Chkhikvadze, T., Coiffard, B., Contreras, A., Costantini, T.W., Brouwer, S., Detry, M.A., Duggal, A., Džavík, V., Effron, M.B., Eng, H.F., Escobedo, J., Estcourt, L.J., Everett, B.M., Fergusson, D.A., Fitzgerald, M., Fowler, R.A., Froess, J.D., Fu, Z., Galanaud, J.P., Galen, B.T., Gandotra, S., Girard, T.D., Goodman, A.L., Goossens, H., Green, C., Greenstein, Y.Y., Gross, P.L., Haniffa, R., Hegde, S.M., Hendrickson, C.M., Higgins, A.M., Hindenburg, A.A., Hope, A.A., Horowitz, J.M., Horvat, C.M., Huang, D.T., Hudock, K., Hunt, B.J., Husain, M., Hyzy, R.C., Jacobson, J.R., Jayakumar, D., Keller, N.M., Khan, A., Kim, Y., Kindzelski, A., King, A.J., Knudson, M.M., Kornblith, A.E., Kutcher, M.E., Laffan, M.A., Lamontagne, F., Gal, G. Le, Veerdonk, F.L. van de, Middeldorp, S., Schouten, J.A., Pickkers, P., Webb, S.A., and Zarychanski, R.

Abstract

Item does not contain fulltext, BACKGROUND: Thrombosis and inflammation may contribute to morbidity and mortality among patients with coronavirus disease 2019 (Covid-19). We hypothesized that therapeutic-dose anticoagulation would improve outcomes in critically ill patients with Covid-19. METHODS: In an open-label, adaptive, multiplatform, randomized clinical trial, critically ill patients with severe Covid-19 were randomly assigned to a pragmatically defined regimen of either therapeutic-dose anticoagulation with heparin or pharmacologic thromboprophylaxis in accordance with local usual care. The primary outcome was organ support-free days, evaluated on an ordinal scale that combined in-hospital death (assigned a value of -1) and the number of days free of cardiovascular or respiratory organ support up to day 21 among patients who survived to hospital discharge. RESULTS: The trial was stopped when the prespecified criterion for futility was met for therapeutic-dose anticoagulation. Data on the primary outcome were available for 1098 patients (534 assigned to therapeutic-dose anticoagulation and 564 assigned to usual-care thromboprophylaxis). The median value for organ support-free days was 1 (interquartile range, -1 to 16) among the patients assigned to therapeutic-dose anticoagulation and was 4 (interquartile range, -1 to 16) among the patients assigned to usual-care thromboprophylaxis (adjusted proportional odds ratio, 0.83; 95% credible interval, 0.67 to 1.03; posterior probability of futility [defined as an odds ratio <1.2], 99.9%). The percentage of patients who survived to hospital discharge was similar in the two groups (62.7% and 64.5%, respectively; adjusted odds ratio, 0.84; 95% credible interval, 0.64 to 1.11). Major bleeding occurred in 3.8% of the patients assigned to therapeutic-dose anticoagulation and in 2.3% of those assigned to usual-care pharmacologic thromboprophylaxis. CONCLUSIONS: In critically ill patients with Covid-19, an initial strategy of therapeutic-dose anticoagulati

Published
2021

4. Therapeutic Anticoagulation with Heparin in Noncritically Ill Patients with Covid-19

Author

Lawler, P.R., Goligher, E.C., Berger, J.S., Neal, M.D., McVerry, B.J., Nicolau, J.C., Gong, M.N., Carrier, M., Rosenson, R.S., Reynolds, H.R., Turgeon, A.F., Escobedo, J., Huang, D.T., Bradbury, C.A., Houston, B.L., Kornblith, L.Z., Kumar, A., Kahn, S.R., Cushman, M., McQuilten, Z., Slutsky, A.S., Kim, K.S., Gordon, A.C., Kirwan, B.A., Brooks, M.M., Higgins, A.M., Lewis, R.J., Lorenzi, E., Berry, S.M., Berry, L.R., Aday, A.W., Al-Beidh, F., Annane, D., Arabi, Y.M., Aryal, D., Kreuziger, L. Baumann, Beane, A., Bhimani, Z., Bihari, S., Billett, H.H., Bond, L., Bonten, M., Brunkhorst, F., Buxton, M., Buzgau, A., Castellucci, L.A., Chekuri, S., Chen, J.T., Cheng, A.C., Chkhikvadze, T., Coiffard, B., Costantini, T.W., Brouwer, S., Derde, L.P.G., Detry, M.A., Duggal, A., Džavík, V., Effron, M.B., Estcourt, L.J., Everett, B.M., Fergusson, D.A., Fitzgerald, M., Fowler, R.A., Galanaud, J.P., Galen, B.T., Gandotra, S., García-Madrona, S., Girard, T.D., Godoy, L.C., Goodman, A.L., Goossens, H., Green, C., Greenstein, Y.Y., Gross, P.L., Hamburg, N.M., Haniffa, R., Hanna, G., Hanna, N., Hegde, S.M., Hendrickson, C.M., Hite, R.D., Hindenburg, A.A., Hope, A.A., Horowitz, J.M., Horvat, C.M., Hudock, K., Hunt, B.J., Husain, M., Hyzy, R.C., Iyer, V.N., Jacobson, J.R., Jayakumar, D., Keller, N.M., Khan, A., Kim, Y., Kindzelski, A.L., King, A.J., Knudson, M.M., Kornblith, A.E., Krishnan, V., Veerdonk, F.L. van de, Schouten, J.A., Pickkers, P., Hochman, J.S., Zarychanski, R., Lawler, P.R., Goligher, E.C., Berger, J.S., Neal, M.D., McVerry, B.J., Nicolau, J.C., Gong, M.N., Carrier, M., Rosenson, R.S., Reynolds, H.R., Turgeon, A.F., Escobedo, J., Huang, D.T., Bradbury, C.A., Houston, B.L., Kornblith, L.Z., Kumar, A., Kahn, S.R., Cushman, M., McQuilten, Z., Slutsky, A.S., Kim, K.S., Gordon, A.C., Kirwan, B.A., Brooks, M.M., Higgins, A.M., Lewis, R.J., Lorenzi, E., Berry, S.M., Berry, L.R., Aday, A.W., Al-Beidh, F., Annane, D., Arabi, Y.M., Aryal, D., Kreuziger, L. Baumann, Beane, A., Bhimani, Z., Bihari, S., Billett, H.H., Bond, L., Bonten, M., Brunkhorst, F., Buxton, M., Buzgau, A., Castellucci, L.A., Chekuri, S., Chen, J.T., Cheng, A.C., Chkhikvadze, T., Coiffard, B., Costantini, T.W., Brouwer, S., Derde, L.P.G., Detry, M.A., Duggal, A., Džavík, V., Effron, M.B., Estcourt, L.J., Everett, B.M., Fergusson, D.A., Fitzgerald, M., Fowler, R.A., Galanaud, J.P., Galen, B.T., Gandotra, S., García-Madrona, S., Girard, T.D., Godoy, L.C., Goodman, A.L., Goossens, H., Green, C., Greenstein, Y.Y., Gross, P.L., Hamburg, N.M., Haniffa, R., Hanna, G., Hanna, N., Hegde, S.M., Hendrickson, C.M., Hite, R.D., Hindenburg, A.A., Hope, A.A., Horowitz, J.M., Horvat, C.M., Hudock, K., Hunt, B.J., Husain, M., Hyzy, R.C., Iyer, V.N., Jacobson, J.R., Jayakumar, D., Keller, N.M., Khan, A., Kim, Y., Kindzelski, A.L., King, A.J., Knudson, M.M., Kornblith, A.E., Krishnan, V., Veerdonk, F.L. van de, Schouten, J.A., Pickkers, P., Hochman, J.S., and Zarychanski, R.

Abstract

Item does not contain fulltext, BACKGROUND: Thrombosis and inflammation may contribute to the risk of death and complications among patients with coronavirus disease 2019 (Covid-19). We hypothesized that therapeutic-dose anticoagulation may improve outcomes in noncritically ill patients who are hospitalized with Covid-19. METHODS: In this open-label, adaptive, multiplatform, controlled trial, we randomly assigned patients who were hospitalized with Covid-19 and who were not critically ill (which was defined as an absence of critical care-level organ support at enrollment) to receive pragmatically defined regimens of either therapeutic-dose anticoagulation with heparin or usual-care pharmacologic thromboprophylaxis. The primary outcome was organ support-free days, evaluated on an ordinal scale that combined in-hospital death (assigned a value of -1) and the number of days free of cardiovascular or respiratory organ support up to day 21 among patients who survived to hospital discharge. This outcome was evaluated with the use of a Bayesian statistical model for all patients and according to the baseline d-dimer level. RESULTS: The trial was stopped when prespecified criteria for the superiority of therapeutic-dose anticoagulation were met. Among 2219 patients in the final analysis, the probability that therapeutic-dose anticoagulation increased organ support-free days as compared with usual-care thromboprophylaxis was 98.6% (adjusted odds ratio, 1.27; 95% credible interval, 1.03 to 1.58). The adjusted absolute between-group difference in survival until hospital discharge without organ support favoring therapeutic-dose anticoagulation was 4.0 percentage points (95% credible interval, 0.5 to 7.2). The final probability of the superiority of therapeutic-dose anticoagulation over usual-care thromboprophylaxis was 97.3% in the high d-dimer cohort, 92.9% in the low d-dimer cohort, and 97.3% in the unknown d-dimer cohort. Major bleeding occurred in 1.9% of the patients receiving therapeutic-dose anticoagul

Published
2021

5. Effect of Convalescent Plasma on Organ Support-Free Days in Critically Ill Patients with COVID-19: A Randomized Clinical Trial.

Author

Estcourt L.J., Turgeon A.F., McQuilten Z.K., McVerry B.J., Al-Beidh F., Annane D., Arabi Y.M., Arnold D.M., Beane A., Begin P., Van Bentum-Puijk W., Berry L.R., Bhimani Z., Birchall J.E., Bonten M.J.M., Bradbury C.A., Brunkhorst F.M., Buxton M., Callum J.L., Chasse M., Cheng A.C., Cove M.E., Daly J., Derde L., Detry M.A., De Jong M., Evans A., Fergusson D.A., Fish M., Fitzgerald M., Foley C., Goossens H., Gordon A.C., Gosbell I.B., Green C., Haniffa R., Harvala H., Higgins A.M., Hills T.E., Hoad V.C., Horvat C., Huang D.T., Hudson C.L., Ichihara N., Laing E., Lamikanra A.A., Lamontagne F., Lawler P.R., Linstrum K., Litton E., Lorenzi E., Maclennan S., Marshall J., McAuley D.F., McDyer J.F., McGlothlin A., McGuinness S., Miflin G., Montgomery S., Mouncey P.R., Murthy S., Nichol A., Parke R., Parker J.C., Priddee N., Purcell D.F.J., Reyes L.F., Richardson P., Robitaille N., Rowan K.M., Rynne J., Saito H., Santos M., Saunders C.T., Serpa Neto A., Seymour C.W., Silversides J.A., Tinmouth A.A., Triulzi D.J., Turner A.M., Van De Veerdonk F., Walsh T.S., Wood E.M., Berry S., Lewis R.J., Menon D.K., McArthur C., Zarychanski R., Angus D.C., Webb S.A., Roberts D.J., Shankar-Hari M., Estcourt L.J., Turgeon A.F., McQuilten Z.K., McVerry B.J., Al-Beidh F., Annane D., Arabi Y.M., Arnold D.M., Beane A., Begin P., Van Bentum-Puijk W., Berry L.R., Bhimani Z., Birchall J.E., Bonten M.J.M., Bradbury C.A., Brunkhorst F.M., Buxton M., Callum J.L., Chasse M., Cheng A.C., Cove M.E., Daly J., Derde L., Detry M.A., De Jong M., Evans A., Fergusson D.A., Fish M., Fitzgerald M., Foley C., Goossens H., Gordon A.C., Gosbell I.B., Green C., Haniffa R., Harvala H., Higgins A.M., Hills T.E., Hoad V.C., Horvat C., Huang D.T., Hudson C.L., Ichihara N., Laing E., Lamikanra A.A., Lamontagne F., Lawler P.R., Linstrum K., Litton E., Lorenzi E., Maclennan S., Marshall J., McAuley D.F., McDyer J.F., McGlothlin A., McGuinness S., Miflin G., Montgomery S., Mouncey P.R., Murthy S., Nichol A., Parke R., Parker J.C., Priddee N., Purcell D.F.J., Reyes L.F., Richardson P., Robitaille N., Rowan K.M., Rynne J., Saito H., Santos M., Saunders C.T., Serpa Neto A., Seymour C.W., Silversides J.A., Tinmouth A.A., Triulzi D.J., Turner A.M., Van De Veerdonk F., Walsh T.S., Wood E.M., Berry S., Lewis R.J., Menon D.K., McArthur C., Zarychanski R., Angus D.C., Webb S.A., Roberts D.J., and Shankar-Hari M.

Abstract

Importance: The evidence for benefit of convalescent plasma for critically ill patients with COVID-19 is inconclusive. Objective(s): To determine whether convalescent plasma would improve outcomes for critically ill adults with COVID-19. Design, Setting, and Participant(s): The ongoing Randomized, Embedded, Multifactorial, Adaptive Platform Trial for Community-Acquired Pneumonia (REMAP-CAP) enrolled and randomized 4763 adults with suspected or confirmed COVID-19 between March 9, 2020, and January 18, 2021, within at least 1 domain; 2011 critically ill adults were randomized to open-label interventions in the immunoglobulin domain at 129 sites in 4 countries. Follow-up ended on April 19, 2021. Intervention(s): The immunoglobulin domain randomized participants to receive 2 units of high-titer, ABO-compatible convalescent plasma (total volume of 550 mL +/- 150 mL) within 48 hours of randomization (n = 1084) or no convalescent plasma (n = 916). Main Outcomes and Measures: The primary ordinal end point was organ support-free days (days alive and free of intensive care unit-based organ support) up to day 21 (range, -1 to 21 days; patients who died were assigned -1 day). The primary analysis was an adjusted bayesian cumulative logistic model. Superiority was defined as the posterior probability of an odds ratio (OR) greater than 1 (threshold for trial conclusion of superiority >99%). Futility was defined as the posterior probability of an OR less than 1.2 (threshold for trial conclusion of futility >95%). An OR greater than 1 represented improved survival, more organ support-free days, or both. The prespecified secondary outcomes included in-hospital survival; 28-day survival; 90-day survival; respiratory support-free days; cardiovascular support-free days; progression to invasive mechanical ventilation, extracorporeal mechanical oxygenation, or death; intensive care unit length of stay; hospital length of stay; World Health Organization ordinal scale score at day 14; veno

Published
2021

8. DELTA² guidance on choosing the target difference and undertaking and reporting the sample size calculation for a randomised controlled trial

Author

Cook, J.A., Julious, S.A., Sones, W., Hampson, L.V., Hewitt, C., Berlin, J.A., Ashby, D., Emsley, R., Fergusson, D.A., Walters, S.J., Wilson, E.C.F., MacLennan, G., Stallard, N., Rothwell, J.C., Bland, M., Brown, L., Ramsay, C.R., Cook, A., Armstrong, D., Altman, D., and Vale, L.D.

Abstract

Randomised controlled trials are considered to be the best method to assess comparative clinical efficacy and effectiveness, and can be a key source of data for estimating cost effectiveness. Central to the design of a randomised controlled trial is an a priori sample size calculation, which ensures that the study has a high probability of achieving its prespecified main objective. Beyond pure statistical or scientific concerns, it is ethically imperative that an appropriate number of study participants be recruited, to avoid imposing the burdens of a clinical trial on more patients than necessary. The scientific concern is satisfied and the ethical imperative is further addressed by the specification of a target difference between treatments that is considered realistic or important by one or more key stakeholder groups. The sample size calculation ensures that the trial will have the required statistical power to identify whether a difference of a particular magnitude exists. In this article, the key messages from the DELTA 2 guidance on determining the target difference and sample size calculation for a randomised controlled trial are presented. Recommendations for the subsequent reporting of the sample size calculation are also provided.

Published
2018

9. Phlebotomy resulting in controlled hypovolemia to prevent blood loss in major hepatic resections (PRICE-1): A feasibility randomized controlled trial

Author

Martel, G., primary, Wherrett, C., additional, Fergusson, D.A., additional, Saidenberg, E., additional, Workneh, A., additional, Saeed, S., additional, Baker, L., additional, Gadbois, K., additional, Jee, R., additional, McVicar, J., additional, Rao, P., additional, Thompson, C., additional, Wong, P., additional, Khalil, JAbou, additional, Bertens, K.A., additional, and Balaa, F.K., additional

Published
2019
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10. DELTA 2 guidance on choosing the target difference and undertaking and reporting the sample size calculation for a randomised controlled trial

Author

Cook, J.A., Julious, S.A., Sones, W., Hampson, L.V., Hewitt, C., Berlin, J.A., Ashby, D., Emsley, R., Fergusson, D.A., Walters, S.J., Wilson, E.C.F., MacLennan, G., Stallard, N., Rothwell, J.C., Bland, M., Brown, L., Ramsay, C.R., Cook, A., Armstrong, D., Altman, D., Vale, L.D., Cook, J.A., Julious, S.A., Sones, W., Hampson, L.V., Hewitt, C., Berlin, J.A., Ashby, D., Emsley, R., Fergusson, D.A., Walters, S.J., Wilson, E.C.F., MacLennan, G., Stallard, N., Rothwell, J.C., Bland, M., Brown, L., Ramsay, C.R., Cook, A., Armstrong, D., Altman, D., and Vale, L.D.

Abstract

Randomised controlled trials are considered to be the best method to assess comparative clinical efficacy and effectiveness, and can be a key source of data for estimating cost effectiveness. Central to the design of a randomised controlled trial is an a priori sample size calculation, which ensures that the study has a high probability of achieving its prespecified main objective. Beyond pure statistical or scientific concerns, it is ethically imperative that an appropriate number of study participants be recruited, to avoid imposing the burdens of a clinical trial on more patients than necessary. The scientific concern is satisfied and the ethical imperative is further addressed by the specification of a target difference between treatments that is considered realistic or important by one or more key stakeholder groups. The sample size calculation ensures that the trial will have the required statistical power to identify whether a difference of a particular magnitude exists. In this article, the key messages from the DELTA 2 guidance on determining the target difference and sample size calculation for a randomised controlled trial are presented. Recommendations for the subsequent reporting of the sample size calculation are also provided. © 2018 Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to.

Published
2018

11. DELTA2 guidance on choosing the target difference and undertaking and reporting the sample size calculation for a randomised controlled trial Suzie Cro

Author

Cook, J.A., Julious, S.A., Sones, W., Hampson, L.V., Hewitt, C., Berlin, J.A., Ashby, D., Emsley, R., Fergusson, D.A., Walters, S.J., Wilson, E.C.F., Maclennan, G., Stallard, N., Rothwell, J.C., Bland, M., Brown, L., Ramsay, C.R., Cook, A., Armstrong, D., Altman, D., Vale, L.D., Cook, J.A., Julious, S.A., Sones, W., Hampson, L.V., Hewitt, C., Berlin, J.A., Ashby, D., Emsley, R., Fergusson, D.A., Walters, S.J., Wilson, E.C.F., Maclennan, G., Stallard, N., Rothwell, J.C., Bland, M., Brown, L., Ramsay, C.R., Cook, A., Armstrong, D., Altman, D., and Vale, L.D.

Abstract

Background: A key step in the design of a RCT is the estimation of the number of participants needed in the study. The most common approach is to specify a target difference between the treatments for the primary outcome and then calculate the required sample size. The sample size is chosen to ensure that the trial will have a high probability (adequate statistical power) of detecting a target difference between the treatments should one exist. The sample size has many implications for the conduct and interpretation of the study. Despite the critical role that the target difference has in the design of a RCT, the way in which it is determined has received little attention. In this article, we summarise the key considerations and messages from new guidance for researchers and funders on specifying the target difference, and undertaking and reporting a RCT sample size calculation. This article on choosing the target difference for a randomised controlled trial (RCT) and undertaking and reporting the sample size calculation has been dual published in the BMJ and BMC Trials journals Methods: The DELTA2 (Difference ELicitation in TriAls) project comprised five major components: systematic literature reviews of recent methodological developments (stage 1) and existing funder guidance (stage 2); a Delphi study (stage 3); a two-day consensus meeting bringing together researchers, funders and patient representatives (stage 4); and the preparation and dissemination of a guidance document (stage 5). Results and Discussion: The key messages from the DELTA2 guidance on determining the target difference and sample size calculation for a randomised caontrolled trial are presented. Recommendations for the subsequent reporting of the sample size calculation are also provided. © 2018 The Author(s).

Published
2018

12. Choosing the target difference and undertaking and reporting the sample size calculation for a randomised controlled trial - The development of the DELTA2 guidance

Author

Sones, W., Julious, S.A., Rothwell, J.C., Ramsay, C.R., Hampson, L.V., Emsley, R., Walters, S.J., Hewitt, C., Bland, M., Fergusson, D.A., Berlin, J.A., Altman, D., Vale, L.D., Cook, J.A., Sones, W., Julious, S.A., Rothwell, J.C., Ramsay, C.R., Hampson, L.V., Emsley, R., Walters, S.J., Hewitt, C., Bland, M., Fergusson, D.A., Berlin, J.A., Altman, D., Vale, L.D., and Cook, J.A.

Abstract

Background: A key step in the design of a randomised controlled trial is the estimation of the number of participants needed. The most common approach is to specify a target difference in the primary outcome between the randomised groups and then estimate the corresponding sample size. The sample size is chosen to provide reassurance that the trial will have high statistical power to detect the target difference at the planned statistical significance level. Alternative approaches are also available, though most still require specification of a target difference. The sample size has many implications for the conduct of the study, as well as incurring scientific and ethical aspects. Despite the critical role of the target difference for the primary outcome in the design of a randomised controlled trial (RCT), the manner in which it is determined has received little attention. This article reports the development of the DELTA2 guidance on the specification and reporting of the target difference for the primary outcome in a sample size calculation for a RCT. Methods: The DELTA2 (Difference ELicitation in TriAls) project has five components comprising systematic literature reviews of recent methodological developments (stage 1) and existing funder guidance (stage 2), a Delphi study (stage 3), a 2-day consensus meeting bringing together researchers, funders and patient representatives (stage 4), and the preparation and dissemination of a guidance document (stage 5). Results: The project started in April 2016. The literature search identified 28 articles of methodological developments relevant to a method for specifying a target difference. A Delphi study involving 69 participants, along with a 2-day consensus meeting were conducted. In addition, further engagement sessions were held at two international conferences. The main guidance text was finalised on April 18, 2018, after revision informed by feedback gathered from stages 2 and 3 and from funder representatives. Dis

Published
2018

14. Substantial risks associated with few clusters in cluster randomized and stepped wedge designs

Author

Taljaard, M., Teerenstra, S., Ivers, N.M., Fergusson, D.A., Taljaard, M., Teerenstra, S., Ivers, N.M., and Fergusson, D.A.

Abstract

Item does not contain fulltext, Given the growing attention to quality improvement, comparative effectiveness research, and pragmatic trials embedded within learning health systems, the use of the cluster randomization design is bound to increase. The number of clusters available for randomization is often limited in such trials. Designs that incorporate pre-intervention measurements (e.g. cluster cross-over, repeated parallel arm, and stepped wedge designs) can substantially reduce the required numbers of clusters by decreasing between-cluster sources of variation. However, there are substantial risks associated with few clusters, including increased probability of chance imbalances and type I and type II error, limited perceived or actual generalizability, and fewer options for statistical analysis. Furthermore, current sample size methods for the stepped wedge design make a strong underlying assumption with respect to the correlation structure-in particular, that the intracluster and inter-period correlations are equal. This is in contrast with methods for the cluster cross-over design that explicitly allow for a smaller inter-period correlation. Failing to similarly allow for the inter-period correlation in the design of a stepped wedge trial may yield perilously low sample sizes. Further methodological and empirical work is required to inform sample size methods and guidance for the stepped wedge trial and to provide minimum thresholds for this design.

Published
2016

15. Using decision aids may improve informed consent for research.

Author

Brehaut, J.C., Fergusson, D.A., Kimmelman, J., Shojania, K.G., Saginur, R., Elwyn, G., Brehaut, J.C., Fergusson, D.A., Kimmelman, J., Shojania, K.G., Saginur, R., and Elwyn, G.

Abstract

1 mei 2010, Contains fulltext : 87549.pdf (publisher's version ) (Closed access), This commentary argues that the existing approach towards obtaining informed consent for clinical research may be improved by using decision aids. Problems with the current approach include i) an emphasis on documentation to the detriment of good quality decision-making; ii) ad hoc rather than theory-based research studying how to improve informed consent; and iii) a lack of clarity around what is meant by 'comprehension' and how to measure it. Decision aids, which clearly improve patient treatment decisions but are new to decisions surrounding study participation, have strengths in precisely the areas where the informed consent literature is weak. Decision aids facilitate a process of decision-making, combining clear documentation, exercises to facilitate decision-making, and consultation. They are increasingly informed by theory and clear, empirically-derived standards. Furthermore, decision aid research has clearly defined and operationalized three indicators of good quality decision-making in situations where there is no objectively correct answer: demonstrable knowledge of key aspects of the decision, accurate perceptions of the probabilities of various outcomes, and a match between preferred outcomes and the choice made. We identify outstanding issues and propose a research approach that will determine whether the use of decision aids can improve the informed consent process.

Published
2010

16. Canadian Surgery Forum1 Is laparoscopic sleeve gastrectomy a reasonable stand-alone procedure for super morbidly obese patients?2 Postoperative monitoring requirements of patients with obstructive sleep apnea undergoing bariatric surgery3 Role of relaparoscopy in the diagnosis and treatment of bariatric complications in the early postoperative period4 Changes of active and total ghrelin, GLP-1 and PYY following restrictive bariatric surgery and their impact on satiety: comparison of sleeve gastrectomy and adjustable gastric banding5 Prioritization and willingness to pay for bariatric surgery: the patient perspective6 Ventral hernia at the time of laparoscopic gastric bypass surgery: Should it be repaired?7 Linear stapled gastrojejunostomy with transverse handsewn enterotomy closure significantly reduces strictures for laparoscopic Roux-en-Y bypass8 Laparoscopic biliopancreatic diversion with duodenal switch as second stage for super super morbidly obese patients. Do all patients benefit?9 Sleeve gastrectomy in the super super morbidly obese (BMI > 60 kg/m2): a Canadian experience10 Laparoscopic gastric bypass for the treatment of refractory idiopathic gastroparesis: a report of 2 cases11 Duodeno-ileal switch as a primary bariatric and metabolic surgical option for the severely obese patient with comorbidities: review of a single-institution case series of duodeno-ileal intestinal bypass12 Management of large paraesophageal hernias in morbidly obese patients with laparoscopic sleeve gastrectomy: a case series13 Early results of the Ontario bariatric surgical program: using the bariatric registry14 Improving access to bariatric surgical care: Is universal health care the answer?15 Early and liberal postoperative exploration can reduce morbidity and mortality in patients undergoing bariatric surgery16 Withdrawn17 Identification and assessment of technical errors in laparoscopic Roux-en-Y gastric bypass18 A valid and reliable tool for assessment of surgical skill in laparoscopic Roux-en-Y gastric bypass19 Psychiatric predictors of presurgery drop-out following suitability assessment for bariatric surgery20 Predictors of outcomes following Roux-en-Y gastric bypass surgery at The Ottawa Hospital21 Prophylactic management of cholelithiasis in bariatric patients: Is routine cholecystectomy warranted?22 Early outcomes of Roux-en-Y gastric bypass in a publicly funded obesity program23 Similar incidence of gastrojejunal anastomotic stricture formation with hand-sewn and 21 mm circular stapler techniques during Roux-en-Y gastric bypass24 (CAGS Basic Science Award) Exogenous glucagon-like peptide-1 improves clinical, morphological and histological outcomes of intestinal adaptation in a distal-intestinal resection piglet model of short bowel syndrome25 (CAGS Clinical Research Award) Development and validation of a comprehensive curriculum to teach an advanced minimally invasive procedure: a randomized controlled trial26 Negative-pressure wound therapy (iVAC) on closed, high-risk incisions following abdominal wall reconstruction27 The impact of seed granting on research in the University of British Columbia Department of Surgery28 Quality of surgical care is inadequate for elderly patients29 Recurrence of inguinal hernia in general and hernia specialty hospitals in Ontario, Canada30 Oncostatin M receptor deficiency results in increased mortality in an intestinal ischemia reperfusion model in mice31 Laparoscopic repair of large paraesophageal hernias with anterior gastropexy: a multicentre trial32 Response to preoperative medical therapy predicts success of laparoscopic splenectomy for immune thrombocytopenic purpura33 Perioperative sepsis, but not hemorrhagic shock, promotes the development of cancer metastases in a murine model34 Measuring the impact of implementing an acute care surgery service on the management of acute biliary disease35 Patient flow and efficiency in an acute care surgery service36 The relationship between treatment factors and postoperative complications after radical surgery for rectal cancer37 Risk of ventral hernia after laparoscopic colon surgery38 Urinary metabolomics as a tool for early detection of Barrett’s and esophageal cancer39 Construct validity of individual and summary performance metrics associated with a computer-based laparo-scopic simulator40 Impact of a city-wide health system reorganization on emergency department visits in hospitals in surrounding communities41 Transcatheter aortic valve implantation for the nonoperative management of aortic stenosis: a cost-effectiveness analysis42 Breast cancer: racial differences in age of onset. A potential confounder in Canadian screening recommendations43 Risk taking in surgery: in and out of the comfort zone44 A tumour board in the office: Track those cancer patients!45 Increased patient BMI is not associated with advanced colon cancer stage or grade on presentation: a retrospective chart review46 Consensus statements regarding the multidisciplinary care of limb amputation patients in disasters or humanitarian emergencies. Report of the 2011 Humanitarian Action Summit Surgical Working Group on amputations following disasters or conflict47 Learning the CanMEDS role of professional: a pilot project of supervised discussion groups addressing the hidden curriculum48 Assessing the changing scope of training in Canadian general surgery programs: expected versus actual experience49 Predicting need for surgical management for massive gastrointestinal hemorrhage50 International health care experience: using CanMEDS to evaluate learning outcomes following a surgical mission in Mampong, Ghana51 The open abdomen: risk factors for mortality and rates of closure52 How surgeons think: an exploration of mental practice in surgical preparation53 The surgery wiki: a novel method for delivery of under-graduate surgical education54 Understanding surgical residents’ postoperative practices before implementing an enhanced recovery after surgery (ERAS) guideline at the University of Toronto55 From laparoscopic transabdominal to posterior retroperitoneal adrenalectomy: a paradigm shift in operative approach56 A retrospective audit of outcomes in patients over the age of 80 undergoing acute care abdominal surgery57 Canadian general surgery residents’ perspectives on work-hour regulations58 Timing of surgical intervention and its outcomes in acute appendicitis59 Preparing surgical trainees to deal with adverse events. An outline of learning issues60 Acute care surgical service: surgeon agreement at the time of handover61 Predicting discharge of elderly patients to prehospitalization residence following emergency general surgery62 Morbidity and mortality after emergency abdominal surgery in octo- and nonagenarians63 The impact of acute abdominal illness and urgent admission to hospital on the living situation of elderly patients64 A comparison of laparoscopic versus open subtotal gastrectomy for antral gastric adenocarcinoma: a North American perspective65 Minimally invasive excision of ectopic mediastinal parathyroid adenomas66 Perioperative outcomes of laparoscopic hernia repair in a tertiary care centre: a single institution’s experience67 Evaluation of a student-run, practical and didactic curriculum for preclerkship medical students68 Joseph Lister: Father of Modern Surgery69 Comparisons of melanoma sentinel lymph node biopsy prediction nomograms in a cohort of Canadian patients70 Local experience with myocutaneous flaps after extensive pelvic surgery71 The treatment of noncirrhotic splanchnic vein thrombosis: Is anticoagulation enough?72 Implementation of an acute care surgery service does not affect wait-times for elective cancer surgeries: an institutional experience73 Use of human collagen mesh for closure of a large abdominal wall defect, after colon cancer surgery, a case report74 The role of miR-200b in pulmonary hypoplasia associated with congenital diaphragmatic hernia75 Systematic review and meta-analysis of electrocautery versus scalpel for incising epidermis and dermis76 Accuracy of sentinel lymph node biopsy for early breast cancer in the community setting in St. John’s, New-foundland: results of a retrospective review77 Acute surgical outcomes in the 80 plus population78 The liberal use of platelets transfusions in the acute phase of trauma resuscitation: a systematic review79 Implementation of an acute care surgical on call program in a Canadian community hospital80 Short-term outcomes following paraesophageal hernia repair in the elderly patient81 First experience with single incision surgery: feasibility in the pediatric population and cost evaluation82 The impact of the establishment of an acute care surgery unit on the outcomes of appendectomies and cholecystectomies83 Description and preliminary evaluation of a low-cost simulator for training and evaluation of flexible endoscopic skills84 Tumour lysis syndrome in metastatic colon cancer: a case report85 Acute care surgery service model implementation study at a single institution86 Colonic disasters approached by emergent subtotal and total colectomy: lessons learned from 120 consecutive cases87 Acellular collagen matrix stent to protect bowel anastomoses88 Lessons we learned from preoperative MRI-guided wire localization of breast lesions: the University Health Network (UHN) experience89 Interim cost comparison for the use of platinum micro-coils in the operative localization of small peripheral lung nodules90 Routine barium esophagram has minimal impact on the postoperative management of patients undergoing esophagectomy for esophageal cancer91 Iron deficiency anemia is a common presenting issue with giant paraesophageal hernia and resolves following repair92 A randomized comparison of different ventilation strategies during thoracotomy and lung resection93 The Canadian Lung Volume Reduction Surgery study: an 8-year follow-up94 A comparison of minimally invasive versus open Ivor-Lewis esophagectomy95 A new paradigm in the follow-up after curative resection for lung cancer: minimal-dose CT scan allows for early detection of asymptomatic cancer activity96 Predictors of lymph node metastasis in early esophageal adenocarcinoma: Is endoscopic resection worth the risk?97 How well can thoracic surgery residents operate? Comparing resident and program director opinions98 The impact of extremes of age on short- and long-term outcomes following surgical resection of esophageal malignancy99 Epidermal growth factor receptor targeted gold nanoparticles for the enhanced radiation treatment of non–small cell lung cancer100 Laparoscopic Heller myotomy results in excellent outcomes in all subtypes of achalasia as defined by the Chicago classification101 Neoadjuvant chemoradiation versus surgery in managing esophageal cancer102 Quality of life postesophagectomy for cancer!103 The implementation, evolution and translocation of standardized clinical pathways can improve perioperative outcomes following surgical treatment of esophageal cancer104 A tissue-mimicking phantom for applications in thoracic surgical simulation105 Sublobar resection compared with lobectomy for early stage non–small cell lung cancer: a single institution study106 Not all reviews are equal: the quality of systematic reviews and meta-analyses in thoracic surgery107 Do postoperative complications affect health-related quality of life after video-assisted thoracoscopic lobectomy for patients with lung cancer? A cohort study108 Thoracoscopic plication for palliation of dyspnea secondary to unilateral diaphragmatic paralysis: A worthwhile venture?109 Thoracic surgery experience in Canadian general surgery residency programs110 Perioperative morbidity and pathologic response rates following neoadjuvant chemotherapy and chemoradiation for locally advanced esophageal carcinoma111 An enhanced recovery pathway reduces length of stay after esophagectomy112 Predictors of dysplastic and neoplastic progression of Barrett’s esophagus113 Recurrent esophageal cancer complicated by tracheoesophageal fistula: management by means of palliative airway stenting114 Pancreaticopleural fistula-induced empyema thoracis: principles and results of surgical management115 Prognostic factors of early postoperative mortality following right extended hepatectomy116 Optimizing steatotic livers for transplantation using a cell-penetrating peptide CPP-fused heme oxygenase117 Video outlining the technical steps for a robot-assisted laparoscopic pancreaticoduodenectomy118 Establishment of a collaborative group to conduct innovative clinical trials in Canada119 Hepatic resection for metastatic malignant melanoma: a systematic review and meta-analysis120 Acellular normothermic ex vivo liver perfusion for donor liver preservation121 Pancreatic cancer and predictors of survival: comparing the CA 19–9/bilirubin ratio with the McGill Brisbane Scoring System122 Staged liver resections for bilobar hepatic colorectal metastases: a single centre experience123 Economic model of observation versus immediate resection of hepatic adenomas124 Resection of colorectal liver metastasis in the elderly125 Acceptable long-term survival in patients undergoing liver resection for metastases from noncolorectal, non-neuroendocrine, nonsarcoma malignancies126 Patient and clinicopathological features and prognosis of CK19+ hepatocellular carcinomas: a case–control study127 The management of blunt hepatic trauma in the age of angioembolization: a single centre experience128 Liver resections for noncolorectal and non-neuroendocrine metastases: an evaluation of oncologic outcomes129 Developing an evidence-based clinical pathway for patients undergoing pancreaticoduodenectomy130 Hepatitis C infection and hepatocellular carcinoma in liver transplant: a 20 year experience131 The effect of medication on the risk of post-ERCP pancreatitis132 Temporal trends in the use of diagnostic imaging for patients with hepato-pancreato-biliary (HPB) conditions: How much ionizing radiation are we really using?196 A phase II study of aggressive metastasectomy for intra-and extrahepatic metastases from colorectal cancer133 Why do women choose mastectomy for breast cancer treatment? A conceptual framework for understanding surgical decision-making in early-stage breast cancer134 Synoptic operative reporting: documentation of quality of care data for rectal cancer surgery135 Learning curve analysis for cytoreductive surgery: a useful application of the cumulative sum (CUSUM) method136 Pancreatic cancer is strongly associated with a unique urinary metabolomic signature137 Concurrent neoadjuvant chemo/radiation in locally advanced breast cancer138 Impact of positron emission tomography on clinical staging of newly diagnosed rectal cancer: a specialized single centre retrospective study139 An evaluation of intraoperative Faxitron microradiography versus conventional specimen radiography for the excision of nonpalpable breast lesions140 Comparison of breast cancer treatment wait-times in the Southern Interior of British Columbia in 2006 and 2010141 Factors affecting lymph nodes harvest in colorectal carcinoma142 Laparoscopic adrenalectomy for metastases143 You have a message! Social networking as a motivator for fundamentals of laparoscopic surgery (FLS) training144 The evaluation and validation of a rapid diagnostic and support clinic for women assessment for breast cancer145 Oncoplastic breast surgery: oncologic benefits and limitations146 A qualitative study on rectal cancer patients’ preferences for location of surgical care147 The effect of surgery on local recurrence in young women with breast cancer148 Elevated IL-6 and IL-8 levels in tumour microenvironment is not associated with increased serum levels in humans with Pseudomyxoma peritonei and peritoneal mesothelioma149 Conversion from laparoscopic to open approach during gastrectomy: a population-based analysis150 A scoping review of surgical process improvement tools (SPITs) in cancer surgery151 Splenectomy during gastric cancer surgery: a population-based study152 Defining the polo-like kinase 4 (Plk4) interactome in cancer cell protrusions153 Neoadjuvant imatinib mesylate for locally advanced gastrointestinal stromal tumours154 Implementing results from ACOSOG Z0011: Practice-changing or practice-affirming?155 Should lymph node retrieval be a surgical quality indicator in colon cancer?156 Long-term outcomes following resection of retroperitoneal recurrence of colorectal cancer157 Clinical research in surgical oncology: an analysis of clinicaltrials.gov158 Radiation therapy after breast conserving surgery: When are we missing the mark?159 The accuracy of endorectal ultrasound in staging rectal lesions in patients undergoing transanal endoscopic microsurgery160 Quality improvement in gastrointestinal cancer surgery: expert panel recommendations for priority research areas161 Factors influencing the quality of local management of ductal carcinoma in situ: a cohort study162 Papillary thyroid microcarcinoma: Does size matter?163 Hyperthermic isolated limb perfusion for extremity soft tissue sarcomas: systematic review of clinical efficacy and quality assessment of reported trials164 Adherence to antiestrogen therapy in seniors with breast cancer: How well are we doing?165 Parathyroid carcinoma: Challenging the surgical dogma?166 A qualitative assessment of the journey to delayed breast reconstruction195 The role of yoga therapy in breast cancer patients167 Outcomes reported in comparative studies of surgical interventions168 Enhanced recovery pathways decrease length of stay following colorectal surgery, but how quickly do patients actually recover?169 The impact of complications on bed utilization after elective colorectal resection170 Impact of trimodal prehabilitation program on functional recovery after colorectal cancer surgery: a pilot study171 Complex fistula-in-ano: Should the plug be abandoned in favour of the LIFT or BioLIFT?172 Prognostic utility of cyclooxygenase-2 expression by colon and rectal cancer173 Laparoscopic right hemicolectomy with complete mesocolic excision provides acceptable perioperative outcomes but is complex and time-consuming: analysis of learning curves for a novice minimally invasive surgeon174 Intraoperative quality assessment following double stapled circular colorectal anastomosis175 Improving patient outcomes through quality assessment of rectal cancer care176 Are physicians willing to accept a decrease in treatment effectiveness for improved functional outcomes for low rectal cancer?177 Turnbull-Cutait delayed coloanal anastomosis for the treatment of distal rectal cancer: a prospective cohort study178 Preoperative high-dose rate brachytherapy in preparation for sphincter preservation surgery for patients with advanced cancer of the lower rectum179 Impact of an enhanced recovery program on short-term outcomes after scheduled laparoscopic colon resection180 The clinical results of the Turnbull-Cutait delayed coloanal anastomosis: a systematic review181 Is a vertical rectus abdominus flap (VRAM) necessary? An analysis of perineal wound complications182 Fistula plug versus endorectal anal advancement flap for the treatment of high transsphincteric cryptoglandular anal fistulas: a systematic review and meta-analysis183 Maternal and neonatal outcomes following colorectal cancer surgery184 Transanal drainage to treat anastomotic leaks after low anterior resection for rectal cancer: a valuable option185 Trends in colon cancer in Ontario: 2002–2009186 Validation of electronically derived short-term outcomes in colorectal surgery187 A population-based assessment of transanal and endoscopic resection for adenocarcinoma of the rectum188 Laparoscopic colorectal surgery in the emergency setting: trends in the province of Ontario from 2002 to 2009189 Prevention of perineal hernia after laparoscopic and robotic abdominoperineal resection: review with case series of internal hernia through pelvic mesh which was placed in attempt to prevent perineal hernia190 Effect of rectal cancer treatments on quality of life191 The use of antibacterial sutures as an adjunctive preventative strategy for surgical site infection in Canada: an economic analysis192 Impact of socioeconomic status on colorectal cancer screening and stage at presentation: preliminary results of a population-based study from an urban Canadian centre193 Initial perioperative results of the first transanal endoscopic microsurgery (TEM) program in the province of Quebec194 Use of negative pressure wound therapy decreases perineal wound infections following abdominal perineal resection

Author

Fayez, R., primary, AlMuntashery, A., primary, Bodie, G., primary, Almamar, A., primary, Gill, R.S., primary, Raîche, I., primary, Mueller, C.L., primary, Moustarah, F., primary, Khokhotva, M., primary, Anvari, M., primary, Kwong, J., primary, Elkassem, S., primary, Bonrath, E., primary, Zevin, B., primary, Sockalingam, S., primary, Smith, C., primary, Whitlock, K.A., primary, Suri, M., primary, Palter, V.N., primary, Wakeam, E., primary, Khan, R.S.A., primary, Martelli, V., primary, Malik, A., primary, Young, P.Y., primary, Daigle, C., primary, McCreery, G., primary, Seth, R., primary, Paskar, D., primary, Sudarshan, M., primary, Richardson, D., primary, Haggar, F., primary, Davis, V.W., primary, Rivard, J., primary, Agzarian, J., primary, Racz, J., primary, Winocour, J., primary, Zilbert, N.R., primary, Decker, C., primary, Neumann, K., primary, Gosney, J.E., primary, Wissanji, H., primary, Chadi, S.A., primary, Alhabboubi, M., primary, Partridge, E., primary, Olszewski, M., primary, Chan, R., primary, Nadler, A., primary, Hameed, U., primary, Brotherhood, H., primary, Menezes, A.S., primary, MacDonald, B., primary, Rakovich, G., primary, Hilsden, R., primary, Merani, S., primary, Davis, P., primary, Davis, P.J.B., primary, Cools-Lartigue, J., primary, Ojah, J., primary, Julien, F., primary, Carter, D., primary, Pitt, D., primary, Banks, B.A., primary, Rudovics, A., primary, Ravichandran, P., primary, Anantha, R., primary, Aad, I., primary, Kholdebarin, R., primary, Aird, L.N.F., primary, Wong, S.L., primary, Payne, J.R.M., primary, Hallet, J., primary, Farries, L., primary, Raiche, I., primary, Botkin, C., primary, Morency, D., primary, Berger-Richardson, D., primary, Isa, A.D., primary, Dupuis, I, primary, Schweigert, M., primary, Koubi, S., primary, Ernjakovic, M., primary, Grant, K., primary, Carrott, P., primary, Stafford, T., primary, Malthaner, R., primary, Hanna, W.C., primary, Lee, L., primary, Markar, S., primary, Razzak, R., primary, Bharadwaj, S.C., primary, Ashrafi, A.S., primary, Ouellette, D., primary, Bottoni, D.A., primary, Knickle, C., primary, Coughlin, S., primary, Gazala, S., primary, Donahoe, L., primary, Walker, K., primary, Li, C., primary, Alnasser, S., primary, Zhuruk, A., primary, Hanouf, A., primary, Vanounou, T., primary, Karanicolas, P., primary, Aubin, J.-M., primary, Yeung, J.C., primary, Dumitra, S., primary, Simoneau, E., primary, Vanounou, T.T., primary, Howe, B., primary, Hawel, J., primary, Jang, J.-H., primary, Bertens, K., primary, Rekman, J.F., primary, Wei, A.C., primary, Ouellet, J.-F., primary, Covelli, A., primary, Maniar, R., primary, Sun, S., primary, Brackstone, M., primary, Boissonneault, R., primary, Kim, S.H.H., primary, Baliski, C., primary, Arnaout, A., primary, Wedman, D., primary, Nostedt, M., primary, Hebbard, P., primary, Shetty, S.J., primary, Dixon, M., primary, Kazazian, K., primary, Lemke, M., primary, Wells, B., primary, Musselman, R.P., primary, Zih, F. Si Wai, primary, Nassif, M., primary, Leon-Carlyle, M., primary, Krotneva, S., primary, Bradley, N.L., primary, Trabulsi, N., primary, Chin-Lenn, L., primary, Cheng, H., primary, Petrucci, A.M., primary, Sandhu, L., primary, Neville, A., primary, Yang, I., primary, Prabhu, K. Lobo, primary, Melich, G., primary, Knowles, S., primary, Borowiec, A.M., primary, Kolozsvari, N.O., primary, Tuttle, P., primary, VanHouwelingen, L., primary, Boulanger-Gobeil, C., primary, Chan, B.P., primary, Phang, P.T., primary, Goldstein, L.J., primary, Wen, C., primary, Lebrun, A., primary, Roy, M., additional, Villeneuve, S., additional, AlMuntashery, A., additional, Demyttenaere, S., additional, Christou, N., additional, Court, O., additional, Fayez, R., additional, Bonrath, E., additional, Hagen, J., additional, Okrainec, A., additional, Sullivan, P., additional, Grantcharov, T., additional, Sharma, A., additional, Karmali, S., additional, Birch, D.W., additional, Majumdar, S.R., additional, Wang, X., additional, Tuepah, R., additional, Klarenbach, S.W., additional, Sharma, A.M., additional, Padwal, R.J., additional, Smith, C., additional, Haggar, F., additional, Moloo, H., additional, Poulin, E.C., additional, Martel, G., additional, Yelle, J.-D., additional, Mamazza, J., additional, Jackson, T.D., additional, Penner, T., additional, Pitzul, K., additional, Urbach, D.R., additional, Biertho, L., additional, Hould, F.-S., additional, Lebel, S., additional, Lescelleur, O., additional, Marceau, S., additional, Marceau, P., additional, Biron, S., additional, Yusuf, S., additional, Pitzul, K.B., additional, Jackson, T., additional, Lindsay, D., additional, Smith, L., additional, Zevin, B., additional, Dedy, N., additional, Grantcharov, T.P., additional, Bonrath, E.M., additional, Aggarwal, R., additional, Cassin, S., additional, Crawford, S., additional, Khan, A., additional, Hawa, R., additional, Brar, B., additional, Raîche, I., additional, Dent, R., additional, Gill, R.S., additional, Ali, T., additional, Shi, X., additional, Whitlock, K.A., additional, Sarkhosh, K., additional, Turner, J.M., additional, Nation, P.N., additional, Wizzard, P., additional, Brubaker, P.L., additional, Gisalet, D.L., additional, Wales, P.W., additional, Tien, H., additional, Spencer, F., additional, Brenneman, F., additional, Kowal, J., additional, Wiseman, S.M., additional, Fraser, S.A., additional, Vedel, I., additional, Deban, M., additional, Holcroft, C., additional, Monette, M., additional, Monette, J., additional, Bergman, S., additional, Bell, C., additional, Stukel, T., additional, Mueller, T.F., additional, Lucykx, V.A., additional, Lukowski, C.M., additional, Compston, C.A., additional, Churchill, T.A., additional, Khadaroo, R.G., additional, Vogt, K., additional, Dubois, L., additional, Gray, D., additional, Ananth, A., additional, Tai, L.-H., additional, Lam, T., additional, Falls, T., additional, Souza, C., additional, Bell, J., additional, Auer, R., additional, Parry, N., additional, Leslie, K., additional, Alhabboubi, M., additional, St-Louis, E., additional, Deckelbaum, D., additional, Razek, T., additional, Feldman, L.S., additional, Khwaja, K., additional, Porter, G., additional, Johnson, P., additional, Boushey, R., additional, Raiche, 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additional, Aikins, C., additional, Roberts, N., additional, Cil, T., additional, Marshall, J., additional, Pederson, K., additional, Erichsen, S., additional, White, J., additional, Aarts, M.-A., additional, Victor, J.C., additional, Pearsall, E., additional, McLeod, R.S., additional, Penner, T.P., additional, Karimuddin, A., additional, Hall, C., additional, Bawan, S., additional, Malik, S., additional, Hayashi, A., additional, McAlister, C., additional, Zhang, N., additional, DesRosiers, Emilie, additional, Mills, A., additional, Crozier, M., additional, Lee, L., additional, Maxwell, J., additional, Partridge, E., additional, Chad, S., additional, Steigerwald, S., additional, Mapiour, D., additional, Roberts, D., additional, MacPherson, C., additional, Donahoe, L., additional, Mercer, D., additional, Hopman, W., additional, Latulippe, J.-F., additional, Knowles, S., additional, Moffat, B., additional, Switzer, N., additional, Tul, Y., additional, Widder, S., additional, Molinari, M., additional, Levy, A., additional, Bailey, J., additional, Hayden, J., additional, Benlolo, S., additional, Marcus, V., additional, Ferri, L., additional, Finley, R., additional, Anderson, D., additional, Gagné, J.-P., additional, Chan, S., additional, Wong, S., additional, Li, J., additional, Michael, A., additional, Choi, D., additional, Liu, E., additional, Hoogenes, J., additional, Dath, D., additional, Aubin, J.-M., additional, Mew, D., additional, McConnell, Y., additional, Classen, D., additional, Kanthan, S., additional, Croome, K.P., additional, Kovacs, M.J., additional, Lazo-Langner, A., additional, Hernandez-Alejandro, R., additional, Khoshgoo, N., additional, Iwasiow, B.M., additional, Keijzer, R., additional, Brown, C.J., additional, Isa, D., additional, Pace, D., additional, Primrose, M., additional, Hudson, D., additional, Lauzier, F., additional, Mailloux, O., additional, Trottier, V., additional, ARchambault, P., additional, Zarychanski, R., additional, Turgeon, A.F., additional, Hardy, P., additional, Muirhead, R.M., additional, Masters, J., additional, Poulin, H. Moloo. E.C., additional, Milbrandt, C., additional, Sideris, L., additional, Grenier-Vallée, P., additional, Dubé, P., additional, Kurashima, Y., additional, Kaneva, P., additional, Fried, G.M., additional, Vassiliou, M.C., additional, Kwan, A.H.-L., additional, Solymosi, N., additional, Rauh, N., additional, Dubecz, A., additional, Renz, M., additional, Ofner, D., additional, Stein, H.J., additional, Borgaonkar, M., additional, Crystal, P., additional, Easson, A., additional, Escallon, J., additional, Reedijk, M., additional, Leong, W.L., additional, McCready, D.R., additional, Clifton, J., additional, Mayo, J., additional, Noreau-Nguyen, M., additional, Mulder, D.S., additional, Ferri, L.E., additional, Markar, S., additional, Hong, J., additional, Low, D.E., additional, Maslow, A., additional, Davignon, K., additional, Ng, T., additional, Tan, L., additional, Aruranian, J., additional, Kosa, S., additional, Murphy, G., additional, Allison, F., additional, Moshonov, H., additional, Darling, G.E., additional, Waddell, T.K., additional, De Perrot, M., additional, Cypel, M., additional, Yasufuku, K., additional, Keshavjee, S., additional, Paul, N.S., additional, Pierre, A.F., additional, Darling, G., additional, Pedneault, C., additional, Low, D., additional, Roa, W., additional, Löbenberg, R., additional, McEwan, S., additional, Bédard, E.L., additional, Louie, B.E., additional, Farivar, A.S., additional, McHugh, S.P., additional, Aye, R.W., additional, Tan-Tam, C., additional, De Vera, M., additional, Bond, R.J., additional, Ong, S.R., additional, Johal, B., additional, Schellenberg, D., additional, Po, M., additional, Nissar, S., additional, Lund, C., additional, Ahmadi, S.Y., additional, Wakil, N., additional, Rakovich, G., additional, Beauchamps, G., additional, Preston, S., additional, Baker, C., additional, Campbell, G., additional, Malthaner, R.A., additional, Bethune, D., additional, Henteleff, H., additional, Johnston, M., additional, Buduhan, G., additional, Coughlin, H. Emmerton, additional, Roth, L., additional, Bhandari, M., additional, Malthaner, R., additional, Johnson, J., additional, Kutsogiannis, J., additional, Bédard, E., additional, Rammohan, K., additional, Stewart, K., additional, Gruchy, J., additional, Xu, Z., additional, Ncuti, A., additional, Neville, A., additional, Watson, D., additional, Vassiliou, M., additional, Carli, F., additional, Av, R., additional, Mayrand, S., additional, Franco, E., additional, Stadlhuber, R.J., additional, Thumfart, L., additional, Croome, K., additional, Leeper, R., additional, Hernandez, R., additional, Livingstone, S., additional, Sapp, J., additional, Woodhall, D., additional, Alwayn, I., additional, Lam-McCulloch, J., additional, Balaa, F., additional, Jayaraman, S., additional, Quan, D., additional, Wei, A., additional, Guyatt, G., additional, Rekman, J.F., additional, Fairfull-Smith, R.J., additional, Mimeault, R., additional, Balaa, F.K., additional, Boehnert, M.S., additional, Bazerbachi, F., additional, Knaak, J.M., additional, Selzner, Nazia, additional, McGilvray, I.D., additional, Rotstein, O.D., additional, Adeyi, O.A., additional, Levy, G.A., additional, Grant, D.R., additional, Selzner, M., additional, Khalil, J. Abou, additional, Jamal, M., additional, Chaudhury, P., additional, Zogopoulos, G., additional, Petrakos, P., additional, Tchervenkov, J., additional, Barkun, J., additional, Jamal, M.H., additional, Hassanain, M., additional, Salman, A., additional, Tran, T., additional, Metrakos, P., additional, Groeschl, R.T., additional, Geller, D.A., additional, Marsh, J.W., additional, Gamblin, T.C., additional, Kim, P.T.W., additional, Greig, P. D., additional, Gallinger, S., additional, Wei, A.C., additional, Fischer, S.E., additional, Cleary, S.P., additional, Vogt, K.N., additional, Gray, D.K., additional, Aubin, J.M., additional, Fairfull-Smith, J.J., additional, Devitt, K.S., additional, Ramjaun, A., additional, Gallingher, S., additional, Alabbad, S., additional, Constantinos, D., additional, Hassanein, M., additional, Paraskevas, S., additional, Tanyingoh, D., additional, Dixon, E., additional, Kaplan, G.G., additional, Myers, R.P., additional, Howard, T.J., additional, Sutherland, F.R., additional, Zyromski, N.J., additional, Ball, C.G., additional, Coburn, N., additional, Law, C.H., additional, Greig, P., additional, Steven, G., additional, Baxter, N., additional, Fitch, M., additional, Wright, F., additional, Hochman, D.J., additional, Wirtzfeld, D.A., additional, Yaffe, C.S., additional, Yip, B., additional, Silverman, R., additional, McConnell, Y.J., additional, Temple, W.J., additional, Mack, L.A., additional, Bathe, O.F., additional, Scott, L., additional, Vandenberg, T., additional, Perera, F., additional, Potvin, K., additional, Chambers, A., additional, Loungnarath, R., additional, DeBroux, É., additional, Lavertu, S., additional, Donath, D., additional, Ayoub, J.-P., additional, Tehfé, M., additional, Richard, C., additional, Cornacchi, S.D., additional, Heller, B., additional, Farrokhyar, F., additional, Babra, M., additional, Lovrics, P.J., additional, Liberto, C., additional, Ghosh, S., additional, McLean, R., additional, Schiller, D., additional, Dumitra, S., additional, Duplisea, J., additional, Wexler, S., additional, Seely, J., additional, Smylie, J., additional, Knight, K., additional, Robertson, S., additional, Watters, J., additional, Zhang, T., additional, Arneout, A., additional, Wirtzfeld, D., additional, Yun, L., additional, Rakovitch, E., additional, Warner, E., additional, McCready, D., additional, Hodgson, N., additional, Quan, M.L., additional, Natarajan, B., additional, Govindarajan, V., additional, Thomas, P., additional, Loggie, B.W., additional, Brar, S., additional, Mahar, A., additional, Law, C., additional, Wiebe, M., additional, Baxter, N.N., additional, Gagliardi, A.R., additional, Kennedy, E.D., additional, Zih, F., additional, Rosario, C., additional, Dennis, J., additional, Gingras, A.-C., additional, Swallow, C., additional, Ko, Y.-J., additional, Rowsell, C., additional, Law, C.H.L., additional, Saskin, R., additional, Quan, M.-L., additional, Xie, M., additional, McLaughlin, K., additional, Marginean, C., additional, Moyana, T.N., additional, Boushey, R.P., additional, Auer, R.C., additional, Razik, R., additional, Haase, E., additional, Mathieson, A., additional, Smith, A.J., additional, Swallow, C.J., additional, Barnes, A., additional, Scheer, A.S., additional, Sabri, E., additional, Auer, R.A.C., additional, Reidel, K., additional, Trabulsi, N., additional, Meterissian, S., additional, Tamblyn, R., additional, Mayo, N., additional, Meguerditchian, A.N., additional, Brown, J.A., additional, Hamm, J., additional, Phang, P.T., additional, Raval, M.J., additional, Taylor, B., additional, Meguerditchian, A., additional, Hamm, J.D., additional, Patakfalvi, L., additional, Nassif, M., additional, Turcotte, R., additional, Nichols, A., additional, Riedel, K.E., additional, Winslade, N.E., additional, Grégoire, J.-P., additional, Abrahamovicz, M., additional, Megueerditchian, A., additional, Pasieka, J., additional, McMillan, C., additional, Lipa, J., additional, Snell, L., additional, Tomlinson, G., additional, Liberman, A.S., additional, Charlebois, P., additional, Stein, B., additional, Capretti, G., additional, Power, A., additional, Augustin, B., additional, Gamsa, A., additional, Kim, D.-J., additional, Feldman, L., additional, Vu, L., additional, Gown, A., additional, Jones, S., additional, Wiseman, S., additional, Jeong, D. Hyoun, additional, Hur, H., additional, Baik, S. Hyuk, additional, Kim, N. Kyu, additional, Faria, J., additional, Min, B. Soh, additional, Lumb, K., additional, Colquhoun, P., additional, Schmocker, S., additional, Huang, H., additional, Krzyzanowska, M. K., additional, Brierley, J., additional, Milot, H., additional, Lebrun, A., additional, Drolet, S., additional, Bouchard, A., additional, Grégoire, R.C., additional, Vuong, T., additional, DeBroux, E., additional, Liberman, S., additional, Powell, R., additional, Fowler, A., additional, Martin, K., additional, Pereira, G., additional, Einarsdottir, K., additional, Gagné, J.P., additional, Thibault, C., additional, Bouchard, P., additional, Gomes, T., additional, Musselman, R.P., additional, Mamdani, M., additional, Al-Omran, M., additional, AlObeed, O., additional, Armstrong, J.B.P., additional, Fergusson, D.A., additional, Forster, A.J., additional, Gomes, Tara, additional, Chan, B.P., additional, Al-Obaid, O., additional, Lim, D. Ro, additional, Gordon, P.H., additional, Lo, A., additional, Pinsk, I., additional, Brown, C., additional, Raval, M., additional, Cheng, H., additional, Wong, C., additional, Johnston, N., additional, Stephen, W., additional, Lindsay, L., additional, Forbes, S., additional, and Parry, N.G., additional

Published
2012
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18. High resolution seismic reflection and its implications for mine risk management: a case study from the Huntly coalfield, New Zealand.

Author

Fergusson D.A., 1997 New Zealand minerals and mining conference Auckland 17-Nov-9719-Nov-97, Fergusson D.A., and 1997 New Zealand minerals and mining conference Auckland 17-Nov-9719-Nov-97

Abstract

Geological hazards such as faulting, basement ridges and zones of thin (less than 6 m) coal have a major impact on mining economics of underground operations in the Huntly coalfield. Drillhole-based investigations do not give sufficiently detailed models of the coal seam. Consequently, operational performance is affected by unplanned costs associated with lower productivity, loss of coal reserves and expensive strata control remedies. It is difficult to obtain good quality seismic reflection data in the area due to the very thick (10-85 m) weathering layer. Since 1994, however, successful acquisition of 2D and 3D data has been achieved through a combination of careful testing of technical parameters and experimental trials prior to committing to production recording. High resolution seismic reflection has been found to generate accurate and reliable models of the coal seam and associated structures. Results of a recent 3D survey at Huntly East mine have shown that the technique can be used successfully for risk management in mine planning., Geological hazards such as faulting, basement ridges and zones of thin (less than 6 m) coal have a major impact on mining economics of underground operations in the Huntly coalfield. Drillhole-based investigations do not give sufficiently detailed models of the coal seam. Consequently, operational performance is affected by unplanned costs associated with lower productivity, loss of coal reserves and expensive strata control remedies. It is difficult to obtain good quality seismic reflection data in the area due to the very thick (10-85 m) weathering layer. Since 1994, however, successful acquisition of 2D and 3D data has been achieved through a combination of careful testing of technical parameters and experimental trials prior to committing to production recording. High resolution seismic reflection has been found to generate accurate and reliable models of the coal seam and associated structures. Results of a recent 3D survey at Huntly East mine have shown that the technique can be used successfully for risk management in mine planning.

Published
1997

19. Cost Effectiveness of Epoetin-α to Augment Preoperative Autologous Blood Donation in Elective Cardiac Surgery.

Author

Coyle, D., Lee, K.M., Fergusson, D.A., and Laupacis, A.

Subjects
COST effectiveness, CARDIAC surgery
Abstract

Objective: The objective of this study was to assess the cost effectiveness of using epoetin-α (erythropoietin) to augment preoperative autologous donation (PAD) of blood prior to elective cardiac surgery. Design and setting: We designed a decision-analytic model incorporating the risk of receiving allogeneic blood, the costs of blood products, the likelihood of developing transfusion-related diseases, the costs of transfusion-related diseases and their impact on life expectancy, and the effect of epoetin-α on the probability of transfusion. Interventions: The efficacy of epoetin-α was derived from data from a meta-analysis of published randomised trials comparing the use of epoetin-α to augment PAD with the use of PAD alone. Estimates for the other parameters were obtained by a systematic review of the literature. Main outcome measures and results: The use of epoetin-α reduced the proportion of patients receiving allogeneic transfusions by 60% (from 31.6 to 12.7%). However, this led to only a modest benefit of 0.000035 life years gained per patient and an incremental cost per life year gained of $Can44.6 million (1998 Canadian dollars). A detailed sensitivity analysis confirmed that the cost-effectiveness ratio was larger than that which is generally considered acceptable. Conclusions: Our study indicates that the use of epoetin-α to reduce perioperative allogeneic transfusions in cardiac surgery is not cost effective. [ABSTRACT FROM AUTHOR]

Published
2000
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20. Long-term risk for major bleeding during extended oral anticoagulant therapy for first unprovoked venous thromboembolism: A systematic review and meta-analysis

Author

Sabine Eichinger, Geert-Jan Geersing, Cecilia Becattini, Walter Ageno, Tobias Tritschler, Grégoire Le Gal, Benilde Cosmi, Paolo Prandoni, Ranjeeta Mallick, Francis Couturaud, Clive Kearon, Kednapa Thavorn, Gary E. Raskob, Charlotte Bradbury, Paul A. Kyrle, Dean Fergusson, Gualtiero Palareti, Harry R. Büller, Letizia Marconi, Philip S. Wells, Lisbeth Eischer, Sameer Parpia, Marc A. Rodger, Giancarlo Agnelli, Cristina Legnani, Michael A. Grosso, Jeffrey I. Weitz, Maria Cristina Vedovati, Antonio Palla, Drahomir Aujesky, Martin Gebel, Faizan Khan, Brian Hutton, Sergio Siragusa, Toshihiko Takada, Miriam Kimpton, Anthonie W. A. Lensing, Khan F., Tritschler T., Kimpton M., Wells P.S., Kearon C., Weitz J.I., Buller H.R., Raskob G.E., Ageno W., Couturaud F., Prandoni P., Palareti G., Legnani C., Kyrle P.A., Eichinger S., Eischer L., Becattini C., Agnelli G., Vedovati M.C., Geersing G.-J., Takada T., Cosmi B., Aujesky D., Marconi L., Palla A., Siragusa S., Bradbury C.A., Parpia S., Mallick R., Lensing A.W.A., Gebel M., Grosso M.A., Thavorn K., Hutton B., Le Gal G., Fergusson D.A., Rodger M.A., Khan, F., Tritschler, T., Kimpton, M., Wells, P.S., Kearon, C., Weitz, J.I., Büller, H.R., Raskob, G.E., Ageno, W., Couturaud, F., Prandoni, P., Palareti, G., Legnani, C., Kyrle, P.A., Eichinger, S., Eischer, L., Becattini, C., Agnelli, G., Vedovati, M.C., Geersing, G.-J., Takada, T., Cosmi, B., Aujesky, D., Marconi, L., Palla, A., Siragusa, S., Bradbury, C.A., Parpia, S., Mallick, R., Lensing, A.W.A., Gebel, M., Grosso, M.A., Thavorn, K., Hutton, B., Le Gal, G., Fergusson, D.A., and Rodger, M.A.

Subjects
Oral, medicine.medical_specialty, medicine.drug_class, Administration, Oral, Hemorrhage, 030204 cardiovascular system & hematology, law.invention, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, law, Risk Factors, Internal medicine, Internal Medicine, Medicine, Humans, Cumulative incidence, Age Factor, 030212 general & internal medicine, Prospective cohort study, 610 Medicine & health, Administration, Oral, Age Factors, Aged, Anticoagulants, Hemorrhage, Humans, Middle Aged, Risk Factors, Venous Thromboembolism, Aged, business.industry, Incidence (epidemiology), Risk Factor, Anticoagulant, Age Factors, Anticoagulants, General Medicine, Venous Thromboembolism, Vitamin K antagonist, Middle Aged, 3. Good health, Concomitant, Meta-analysis, Administration, business, Cohort study, Human
Abstract

BACKGROUND The long-term risk for major bleeding in patients receiving extended (beyond the initial 3 to 6 months) anticoagulant therapy for a first unprovoked venous thromboembolism (VTE) is uncertain. PURPOSE To determine the incidence of major bleeding during extended anticoagulation of up to 5 years among patients with a first unprovoked VTE, overall, and in clinically important subgroups. DATA SOURCES MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials from inception to 23 July 2021. STUDY SELECTION Randomized controlled trials (RCTs) and prospective cohort studies reporting major bleeding among patients with a first unprovoked VTE who were to receive oral anticoagulation for a minimum of 6 additional months after completing at least 3 months of initial anticoagulant treatment. DATA EXTRACTION Two reviewers independently abstracted data and assessed study quality. Unpublished data required for analyses were obtained from authors of included studies. DATA SYNTHESIS Among the 14 RCTs and 13 cohort studies included in the analysis, 9982 patients received a vitamin K antagonist (VKA) and 7220 received a direct oral anticoagulant (DOAC). The incidence of major bleeding per 100 person-years was 1.74 events (95% CI, 1.34 to 2.20 events) with VKAs and 1.12 events (CI, 0.72 to 1.62 events) with DOACs. The 5-year cumulative incidence of major bleeding with VKAs was 6.3% (CI, 3.6% to 10.0%). Among patients receiving either a VKA or a DOAC, the incidence of major bleeding was statistically significantly higher among those who were older than 65 years or had creatinine clearance less than 50 mL/min, a history of bleeding, concomitant use of antiplatelet therapy, or a hemoglobin level less than 100 g/L. The case-fatality rate of major bleeding was 8.3% (CI, 5.1% to 12.2%) with VKAs and 9.7% (CI, 3.2% to 19.2%) with DOACs. LIMITATION Data were insufficient to estimate incidence of major bleeding beyond 1 year of extended anticoagulation with DOACs. CONCLUSION In patients with a first unprovoked VTE, the long-term risks and consequences of anticoagulant-related major bleeding are considerable. This information will help inform patient prognosis and guide decision making about treatment duration for unprovoked VTE. PRIMARY FUNDING SOURCE Canadian Institutes of Health Research. (PROSPERO: CRD42019128597).

Published
2021

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