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1. Protocol implementation during the COVID-19 pandemic: experiences from a randomized trial of stress ulcer prophylaxis

Author

Dennis, Brittany, Deane, Adam, Lauzier, François, Zytaruk, Nicole, Hardie, Miranda, Hammond, Naomi, Finfer, Simon, Arabi, Yaseen, Marshall, John, Saunders, Lois, Heels-Ansdell, Diane, Myburgh, John, Knowles, Serena, Muscedere, John, Ostermann, Marlies, Rajbhandari, Dorrilyn, English, Shane, Matic, Karlo, Venkatesh, Bala, Al Fares, Abdulrahman, Guyatt, Gordon, Alhazzani, Waleed, Mumtaz, Hassan, Poole, Alexis, Xie, Feng, Thabane, Lehana, Hall, Richard, and Cook, Deborah

Published
2024
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2. Enhancing end of life care on general internal medical wards: the 3 Wishes Project

Author

Reid, Julie C, Dennis, Brittany, Hoad, Neala, Clarke, France, Hanmiah, Rajendar, Vegas, Daniel Brandt, Boyle, Anne, Toledo, Feli, Rudkowski, Jill C, Soth, Mark, Heels-Ansdell, Diane, Cheung, Andrew, Willison, Kathleen, Neville, Thanh H, Cheung, Jason, Woods, Anne, and Cook, Deborah

Subjects
Health Services and Systems, Health Sciences, Prevention, Good Health and Well Being, Humans, Pandemics, COVID-19, Terminal Care, Hospice Care, Intensive Care Units, End-of-life, Palliative care, Acute care, Compassionate care, Patient-centered care, Empathy, Nursing, Public Health and Health Services, Gerontology, Health services and systems
Abstract

BackgroundInitially developed in the intensive care unit (ICU) at St. Joseph's Healthcare Hamilton (SJHH) the 3 Wishes Project (3WP) provides personalized, compassionate care to dying patients and their families. The objective of this study was to develop and evaluate 3WP expansion strategies for patients cared for on General Internal Medicine (GIM) wards in our hospital.MethodsFrom January 2020-November 2021, we developed a phased, multicomponent approach for program expansion. We enrolled patients on the GIM wards who had a high probability of dying in hospital, then elicited, implemented, and documented wishes for them or their families. Data were analyzed descriptively.ResultsFrom March 2020 to November 2020, we implemented staff education and engagement activities, created an Expansion Coordinator position, held strategic consultations, and offered enabling resources. From March 2020 to November 2021, we enrolled 62 patients and elicited 281 wishes (median [1st, 3rd quartiles] 4 [4, 5] wishes/patient). The most common wish categories were personalizing the environment (67 wishes, 24%), rituals and spiritual support (42 wishes, 15%), and facilitating connections (39 wishes, 14%). The median [1st, 3rd] cost/patient was $0 [0, $10.00] (range $0 to $86); 91% of wishes incurred no cost to the program.ConclusionsThe formal expansion of the 3WP on GIM wards has been successful despite COVID-19 pandemic disruptions. While there is still work ahead, these data suggest that implementing the 3WP on the GIM wards is feasible and affordable. Increased engagement of the clinical team during the pandemic suggests that it is positively received.

Published
2023

3. The relative merits of using a high-sensitivity cardiac Troponin T assay compared to a nonhigh-sensitivity troponin T assay after noncardiac surgery

Author

Borges, Flavia K., Sessler, Daniel I., Tiboni, Maria, Patel, Ameen, LeManach, Yannick, Heels-Ansdell, Diane, Srinathan, Sadeesh, Wang, Chew Yin, Chow, Clara, Duceppe, Emmanuelle, Kavsak, Peter, Ofori, Sandra N., Pettit, Shirley, Berwanger, Otavio, Kurz, Andrea, Turan, Alparslan, Tonelli, Ana Claudia, and Devereaux, PJ

Published
2024
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4. Time from injury to hip-fracture surgery in low-income and middle-income regions: a secondary analysis of data from the International Orthopaedic Multicentre Study in Fracture Care (INORMUS)

Author

Guyatt, Gordon, Petrisor, Brad, Thabane, Lehana, Boniface, Respicious, Browner, Bruce, Pollak, Andrew, Slobogean, Gerard, Schemitsch, Emil, McKay, Paula, Tai, Kerry, Heels-Ansdell, Diane, Buckingham, Lisa, Norton, Robyn, Zhang, Jing, Parveen, Samina, Bhaumik, Soumyadeep, Morshed, Saam, Mackechnie, Madeline C., Zhang, Zhentao, Ma, Yinghua, Qin, Yanguo, Hu, Sanbao, Qi, Baochang, Dai, Wenjie, Cai, Xinyu, Rui, Gang, Chen, Hua, Shetty, Vijay, Dumbre Patil, Sampat, Patil, Sanjay, Shrivastava, Sandeep, Mittal, Ravi, Jepegnanam, Thilak Samuel, Mahajan, Anupam, Chhabra, Harvinder Singh, N, Rajagopalan, Amaravathi, Rajkumar S., Dhillon, Mandeep S., Chase, Asolie, Bhavsar, Neel M., Saadat, Soheil, Byanjankar, Subin, Qadir, Raja Irfan, Tabu, Irewin Alagar, Ponggsamakthai, Wanjak, Sa-ngasoongsong, Paphon, Subramanian, Panchu, Ndeleva, Benjamin Muluku, Lutomia, Mark, Otseyeno, Fred Mathew Toboso, Mwangi, Geoffrey Chege, Ndasi, Henry Tanyi, Konadu-Yeboah, Dominic, Firth, Gregory, Marealle, Paul, Temu, Rogers, Mutanda, Tony, Rio, Marcelo, Quintero, Jose Eduardo, Zuluaga, Mauricio, Minueza, Tomás, Madrigal, Ricardo, Ylizaliturri, Manuel, Garuz, Mario, Segovia Altieri, Julio, Escalante Elguezabal, Igor A., Armstrong, Elizabeth, Rogers, Kris, Li, Chuan Silvia, Jagnoor, Jagnoor, Moroz, Paul, Oguzie, Gerald Chukwuemeka, Hailu, Samuel, Miclau, Theodore, III, de la Huerta, Fernando, Martinez-Ruiz, Jose de Jesus, Bidolegui, Fernando, Zhou, Junlin, Ma, Xinlong, Wu, Bo, Sancheti, Parag, Quang, La Ngoc, Baigi, Vali, Haddadi, Mashyaneh, Tian, Maoyi, Sprague, Sheila, Devereaux, P J, Bhandari, Mohit, and Ivers, Rebecca

Published
2024
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5. Reamed compared with unreamed nailing of tibial shaft fractures: Does the initial method of nail insertion influence outcome in patients requiring reoperations?

Author

Schemitsch, Emil H., Kumar, Ashesh, Heels-Ansdell, Diane, Sprague, Sheila, Bhandari, Mohit, Guyatt, Gordon, Sanders, David W., Swiontkowski, Marc, Tornetta, Paul, III, and Walter, Stephen

Subjects
Fractures -- Patient outcomes -- Care and treatment -- Methods -- Comparative analysis, Health, Health care industry
Abstract

Background: Patients with a tibial shaft fracture experiencing their first postoperative complication following treatment with intramedullary nails may be at greater risk of subsequent complications than the whole population. We aimed to determine whether the initial method of nail insertion influences outcome in patients with a tibial shaft fracture requiring multiple reoperations. Methods: Using the Study to Prospectively Evaluate Reamed Intramedullary Nails in Tibial Shaft Fractures trial data, we categorized patients as those not requiring reoperation, those requiring a single reoperation and those requiring multiple reoperations, and we compared them by nail insertion technique (reamed v. unreamed) and fracture type (open v. closed). We then determined the number of patients whose first reoperation was in response to infection, and we compared other clinical outcomes between the reamed and unreamed groups. Results: Among 1226 patients included in this analysis, 175 (14.27%) experienced a single reoperation and 44 patients (3.59%) underwent multiple reoperations. Nail insertion techniques (reamed v. unreamed) did not play a role in the need to perform multiple reoperations. Seventy-five percent of patients requiring multiple reoperations had open tibial shaft fractures. An equal number of these were reamed and unreamed insertions. The majority of patients had their course complicated by infection and almost 50% of patients whose first reoperation was for infection required more than 2 reoperations for management. The rest required multiple procedures for nonunion or bone loss. Conclusion: Our findings corroborate those of other studies, in which open fracture type rather than nail insertion technique was found to be the cause of morbidity following intramedullary nailing of tibial fractures. Clinical trial registration: www.ClinicalTrials.gov, no. NCT00038129 Contexte : Les cas de fracture de la diaphyse tibiale qui présentent une première complication postopératoire après un enclouage centromédullaire pourraient être exposés à un risque plus grand de complications ultérieures comparativement à la population générale. Nous avons voulu déterminer si la technique initiale d'enclouage a une influence sur les résultats lorsqu'une fracture de la diaphyse tibiale requiert plusieurs réinterventions. Méthodes : À partir de l'essai intitulé Study to Prospectively Evaluate Reamed Intramedullary Nails in Tibial Shaft Fractures pour l'évaluation prospective de l'enclouage alésé des fractures de la diaphyse tibiale, nous avons établi les catégories suivantes : aucune réintervention, 1 seule réintervention et multiples réinterventions, et nous les avons comparées aux plans de la technique d'enclouage (avec c. sans alésage) et du type de fracture (ouverte c. fermée). Nous avons ensuite établi le nombre de cas pour lesquels la première réintervention découlait d'une infection, et nous avons comparé d'autres paramètres cliniques entre les groupes avec et sans alésage. Résultats : Sur les 1226 cas inclus dans cette analyse, 175 (14,27%) ont subi 1 seule réintervention et 44 (3,59%) en ont subi plusieurs. Les techniques d'enclouage (avec c. sans alésage) n'ont joué aucun rôle dans le recours à de multiples réinterventions. Soixante-quinze pour cent des cas soumis à de multiples réinterventions étaient des fractures ouvertes. Parmi ceuxci, il y avait autant d'enclouages alésés que non alésés. Dans la majorité des cas, la complication était une infection et près de 50% dont la première réintervention découlait d'une infection ont eu besoin de 2 réinterventions pour en venir à bout. Dans les autres cas, les multiples interventions étaient justifiées par des fractures non consolidées ou une perte osseuse. Conclusion : Nos observations confirment les conclusions d'autres études selon lesquelles la cause de la morbidité suivant l'enclouage centromédullaire des fractures tibiales est le type de fracture ouverte plutôt que la technique d'enclouage. Enregistrement de l'essai : www.ClinicalTrials.gov, no. NCT00038129, In the management of tibial shaft fractures, postoperative complications, specifically those that result in a reoperation, are a very important outcome to consider. The likelihood of experiencing a postoperative complication [...]

Published
2023
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6. Risk Factors for Hospital Readmission Following Noncardiac Surgery: International Cohort Study

Author

McGillion, Michael H., Borges, Flavia K., Conen, David, Sessler, Daniel I., Coleman, Brenda L., Marcucci, Maura, Ouellette, Carley, Bird, Marissa, Whitmore, Carly, Henry, Shaunattonie, Ofori, Sandra, Pettit, Shirley M., Bedini, Deborah M., Gauthier, Leslie P., Lounsbury, Jennifer, Carter, Nancy M., Tandon, Vikas, Patel, Ameen, Cafaro, Teresa, Simunovic, Marko R., Harlock, John A., Heels-Ansdell, Diane, Elias, Fadi, Rapanos, Theodore, Forbes, Shawn, Peter, Elizabeth, Watt-Watson, Judy, Metcalfe, Kelly, Carroll, Sandra L., and Devereaux, Philip J.

Published
2024
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8. REVISE: re-evaluating the inhibition of stress erosions in the ICU—statistical analysis plan for a randomized trial

Author

Heels-Ansdell, Diane, Billot, Laurent, Thabane, Lehana, Alhazzani, Waleed, Deane, Adam, Guyatt, Gordon, Finfer, Simon, Lauzier, François, Myburgh, John, Young, Paul, Arabi, Yaseen, Marshall, John, English, Shane, Muscedere, John, Ostermann, Marlies, Venkatesh, Bala, Zytaruk, Nicole, Hardie, Miranda, Hammond, Naomi, Knowles, Serena, Saunders, Lois, Poole, Alexis, Al-Fares, Abdulrahman, Xie, Feng, Hall, Richard, and Cook, Deborah

Published
2023
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9. Proton pump inhibitors in critically ill mechanically ventilated patients with COVID-19: protocol for a substudy of the Re-EValuating the Inhibition of Stress Erosions (REVISE) Trial

Author

Dennis, Brittany B., Thabane, Lehana, Heels-Ansdell, Diane, Dionne, Joanna C., Binnie, Alexandra, Tsang, Jennifer, Guyatt, Gordon, Ahmed, Aijaz, Lauzier, François, Deane, Adam, Arabi, Yaseen, Marshall, John, Zytaruk, Nicole, Saunders, Lois, Finfer, Simon, Myburgh, John, Muscedere, John, English, Shane, Ostermann, Marlies, Hardie, Miranda, Knowles, Serena, and Cook, Deborah

Published
2023
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12. One-year Outcomes after Discharge from Noncardiac Surgery and Association between Predischarge Complications and Death after Discharge: Analysis of the VISION Prospective Cohort Study

Author

Roshanov, Pavel S., Chan, Matthew T. V., Borges, Flavia K., Conen, David, Wang, C. Y., Xavier, Denis, Berwanger, Otavio, Marcucci, Maura, Sessler, Daniel I., Szczeklik, Wojciech, Spence, Jessica, Alonso-Coello, Pablo, Fernández, Carmen, Pearse, Rupert M., Malaga, German, Garg, Amit X., Srinathan, Sadeesh K., Jacka, Michael J., Tandon, Vikas, McGillion, Michael, Popova, Ekaterine, Sigamani, Alben, Abraham, Valsa, Biccard, Bruce M., Villar, Juan Carlos, Chow, Clara K., Polanczyk, Carísi A., Tiboni, Maria, Whitlock, Richard, Ackland, Gareth L., Panju, Mohamed, Lamy, André, Sapsford, Robert, Williams, Colin, Wu, William Ka Kei, Cortés, Olga L., MacNeil, S. Danielle, Patel, Ameen, Belley-Côté, Emilie P., Ofori, Sandra, McIntyre, William F., Leong, Darryl P., Heels-Ansdell, Diane, Gregus, Krysten, and Devereaux, P. J.

Published
2024
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13. Implementing stakeholder engagement to explore alternative models of consent: An example from the PREP-IT trials

Author

Pechero, Guillermo, Pfaff, Branden, Rao, Mayank, Pogorzelski, David, McKay, Paula, Spicer, Ella, Howe, Andrea, Demyanovich, Haley K, Sietsema, Debra L, McTague, Michael F, Ramsey, Lolita, Holden, Martha, Rudnicki, Joshua, Wells, Jeff, Medeiros, Michelle, Slobogean, Gerard P, Sprague, Sheila, Investigators, PREP-IT, Wells, Jeffrey, Bhandari, Mohit, Committee, Steering, D'Alleyrand, Jean-Claude, Harris, Anthony D, Mullins, Daniel C, Thabane, Lehana, Wood, Amber, Committee, Adjudication, Della Rocca, Gregory J, Hebden, Joan, Jeray, Kyle J, Marchand, Lucas, O'Hara, Lyndsay M, Zura, Robert, Committee, Data and Safety Monitoring, Gardner, Michael J, Blasman, Jenna, Davies, Jonah, Liang, Stephen, Taljaard, Monica, Core, Research Methodology, Devereaux, PJ, Guyatt, Gordon H, Heels-Ansdell, Diane, Core, Patient Centred Outcomes, Marvel, Debra, Palmer, Jana, Friedrich, Jeff, O'Hara, Nathan N, Grissom, Frances, Core, Orthopaedic Surgery, Gitajn, I Leah, Morshed, Saam, O'Toole, Robert V, Petrisor, Bradley A, Core, Room, Camara, Megan, Mossuto, Franca, Core, Infectious Disease, Joshi, Manjari G, Core, Fowler, Justin, Rivera, Jessica, Talbot, Max, Dodds, Shannon, Garibaldi, Alisha, Li, Silvia, Nguyen, Uyen, Rojas, Alejandra, Scott, Taryn, Del Fabbro, Gina, Szasz, Olivia Paige, Demyanovich, Haley, Little, Kelly, Mullins, C Daniel, Kettering, Eric, Hale, Diamond, Sites, PREP-IT Clinical, Eglseder, Andrew, Johnson, Aaron, Langhammer, Christopher, Lebrun, Christopher, Manson, Theodore, and Nascone, Jason

Subjects
Clinical Research, Patient Safety, Clinical Trials and Supportive Activities, Health and social care services research, 8.4 Research design and methodologies (health services), PREP-IT Investigators, Steering Committee, Adjudication Committee, Data and Safety Monitoring Committee, Research Methodology Core, Patient Centred Outcomes Core, Orthopaedic Surgery Core, Operating Room Core, Infectious Disease Core, Military Core, PREP-IT Clinical Sites, Aqueous-PREP and PREPARE, Aqueous-PREP, PREPARE, Cluster randomized crossover, Consent, Deferred consent, Patient advisors, Stakeholder engagement, Trial design
Abstract

IntroductionCluster randomized crossover trials are often faced with a dilemma when selecting an optimal model of consent, as the traditional model of obtaining informed consent from participant's before initiating any trial related activities may not be suitable. We describe our experience of engaging patient advisors to identify an optimal model of consent for the PREP-IT trials. This paper also examines surrogate measures of success for the selected model of consent.MethodsThe PREP-IT program consists of two multi-center cluster randomized crossover trials that engaged patient advisors to determine an optimal model of consent. Patient advisors and stakeholders met regularly and reached consensus on decisions related to the trial design including the model for consent. Patient advisors provided valuable insight on how key decisions on trial design and conduct would be received by participants and the impact these decisions will have.ResultsPatient advisors, together with stakeholders, reviewed the pros and cons and the requirements for the traditional model of consent, deferred consent, and waiver of consent. Collectively, they agreed upon a deferred consent model, in which patients may be approached for consent after their fracture surgery and prior to data collection. The consent rate in PREP-IT is 80.7%, and 0.67% of participants have withdrawn consent for participation.DiscussionInvolvement of patient advisors in the development of an optimal model of consent has been successful. Engagement of patient advisors is recommended for other large trials where the traditional model of consent may not be optimal.

Published
2021

14. Prophylactic Antibiotic Regimens In Tumor Surgery (PARITY): a multi-center randomized controlled study comparing alternative antibiotic regimens in patients undergoing tumor resections with endoprosthetic replacements-a statistical analysis plan.

Author

Schneider, Patricia, Heels-Ansdell, Diane, Thabane, Lehana, Ghert, Michelle, and PARITY Investigators

Subjects
PARITY Investigators, Humans, Surgical Wound Infection, Bone Neoplasms, Anti-Bacterial Agents, Limb Salvage, Parity, Pregnancy, Female, Antibiotics, Bone sarcoma, Orthopedic oncology, Randomized controlled trial, Statistical analysis plan, Rare Diseases, Clinical Trials and Supportive Activities, Antimicrobial Resistance, Orphan Drug, Cancer, Clinical Research, Patient Safety, 6.4 Surgery, Musculoskeletal, Cardiovascular System & Hematology, General & Internal Medicine, Cardiorespiratory Medicine and Haematology, Clinical Sciences
Abstract

BackgroundLimb salvage with endoprosthetic reconstruction is the current standard practice for the surgical management of lower extremity bone tumors in skeletally mature patients and typically includes tumor resection followed by the functional limb reconstruction with modular metallic and polyethylene endoprosthetic implants. However, owing to the complexity and length of these procedures, as well as the immunocompromised nature of patients treated with chemotherapy, the risk of surgical site infection (SSI) is high. The primary research objective of the Prophylactic Antibiotic Regimens In Tumor Surgery (PARITY) trial is to assess whether a 5-day regimen of post-operative antibiotics decreases the risk of SSI at 1 year post-operatively compared to a 1-day regimen. This article describes the statistical analysis plan for the PARITY trial.Methods/designThe PARITY trial is an ongoing multi-center, blinded parallel two-arm randomized controlled trial (RCT) of 600 participants who have been diagnosed with a primary bone tumor, a soft tissue sarcoma that has invaded the bone or oligometastatic bone disease of the femur or tibia that requires surgical resection and endoprosthetic reconstruction. This article describes the overall analysis principles, including how participants will be included in each analysis, the presentation of results, adjustments for covariates, the primary and secondary outcomes, and their respective analyses. Additionally, we will present the planned sensitivity and sub-group analyses.DiscussionOur prior work has demonstrated (1) high rates of SSI after the treatment of lower extremity tumors by surgical excision and endoprosthetic reconstruction, (2) highly varied opinion and practice among orthopedic oncologists with respect to prophylactic antibiotic regimens, (3) an absence of applicable RCT evidence, (4) extensive support from international investigators to participate in a RCT, and (5) the feasibility of conducting a definitive RCT to evaluate a 5-day regimen of post-operative antibiotics in comparison with a 1-day regimen.Trial registrationClinicalTrials.gov NCT01479283 . Registered on 24 November 2011.

Published
2021

15. Managing work flow in high enrolling trials: The development and implementation of a sampling strategy in the PREPARE trial

Author

Pogorzelski, David, Nguyen, Uyen, McKay, Paula, Thabane, Lehana, Camara, Megan, Ramsey, Lolita, Seymour, Rachel, Goodman, J Brett, McGee, Sheketha, Fraifogl, Joanne, Hudgins, Andrea, Tanner, Stephanie L, Bhandari, Mohit, Slobogean, Gerard P, Sprague, Sheila, Committee:, on behalf of the PREP-IT Investigators Executive, Wells, Jeffrey, Committee, Steering, D'Alleyrand, Jean-Claude, Harris, Anthony D, Mullins, Daniel C, Wood, Amber, Committee, Adjudication, Della Rocca, Gregory J, Hebden, Joan, Jeray, Kyle J, Marchand, Lucas, O'Hara, Lyndsay M, Zura, Robert, Committee, Data and Safety Monitoring, Gardner, Michael J, Blasman, Jenna, Davies, Jonah, Liang, Stephen, Taljaard, Monica, Core, Research Methodology, Devereaux, PJ, Guyatt, Gordon H, Heels-Ansdell, Diane, Core, Patient Centred Outcomes, Marvel, Debra, Palmer, Jana, Friedrich, Jeff, O'Hara, Nathan N, Grissom, Frances, Core, Orthopaedic Surgery, Gitajn, I Leah, Morshed, Saam, O'Toole, Robert V, Petrisor, Bradley A, Core, Room, Mossuto, Franca, Core, Infectious Disease, Joshi, Manjari G, Core, Fowler, Justin, Rivera, Jessica, Talbot, Max, Center, McMaster University Methods, Dodds, Shannon, Garibaldi, Alisha, Li, Silvia, Rojas, Alejandra, Scott, Taryn, Del Fabbro, Gina, Szasz, Olivia Paige, Center, University of Maryland School of Medicine Administrative, Howe, Andrea, Rudnicki, Joshua, Demyanovich, Haley, Little, Kelly, School of Pharmacy, The PATIENTS Program University of Maryland, Mullins, C Daniel, Medeiros, Michelle, Kettering, Eric, Hale, Diamond, Site, PREP-IT Clinical Sites Lead Clinical, Eglseder, Andrew, Johnson, Aaron, Langhammer, Christopher, Lebrun, Christopher, Manson, Theodore, Nascone, Jason, Paryavi, Ebrahim, and Pensy, Raymond

Subjects
Health Services, Clinical Trials and Supportive Activities, Clinical Research, Good Health and Well Being, PREP-IT Investigators Executive Committee:, Steering Committee, Adjudication Committee, Data and Safety Monitoring Committee, Research Methodology Core, Patient Centred Outcomes Core, Orthopaedic Surgery Core, Operating Room Core, Infectious Disease Core, Military Core, McMaster University Methods Center, University of Maryland School of Medicine Administrative Center, University of Maryland School of Pharmacy, The PATIENTS Program, PREP-IT Clinical Sites: Lead Clinical Site, Aqueous-PREP and PREPARE, Aqueous-PREP, PREPARE, PREP-IT Investigators Executive Committee, Cluster crossover, Pragmatic, Sampling, Sampling framework, Sampling strategy, Work flow
Abstract

IntroductionPragmatic trials in comparative effectiveness research assess the effects of different treatment, therapeutic, or healthcare options in clinical practice. They are characterized by broad eligibility criteria and large sample sizes, which can lead to an unmanageable number of participants, increasing the risk of bias and affecting the integrity of the trial. We describe the development of a sampling strategy tool and its use in the PREPARE trial to circumvent the challenge of unmanageable work flow.MethodsGiven the broad eligibility criteria and high fracture volume at participating clinical sites in the PREPARE trial, a pragmatic sampling strategy was needed. Using data from PREPARE, descriptive statistics were used to describe the use of the sampling strategy across clinical sites. A Chi-square test was performed to explore whether use of the sampling strategy was associated with a reduction in the number of missed eligible patients.Results7 of 20 clinical sites (35%) elected to adopt a sampling strategy. There were 1539 patients excluded due to the use of the sampling strategy, which represents 30% of all excluded patients and 20% of all patients screened for participation. Use of the sampling strategy was associated with lower odds of missed eligible patients (297/4545 (6.5%) versus 341/3200 (10.7%) p

Published
2021

17. Risk Factors Associated With Infection in Open Fractures of the Upper and Lower Extremities.

Author

Tornetta, Paul, Della Rocca, Gregory J, Morshed, Saam, Jones, Clifford, Heels-Ansdell, Diane, Sprague, Sheila, Petrisor, Brad, Jeray, Kyle J, Del Fabbro, Gina, Bzovsky, Sofia, Bhandari, Mohit, and FLOW Investigators

Subjects
FLOW Investigators
Abstract

IntroductionOpen fractures are associated with a high risk of infection. The prevention of infection is the single most important goal, influencing perioperative care of patients with open fractures. Using data from 2,500 participants with open fracture wounds enrolled in the Fluid Lavage of Open Wounds trial, we conducted a multivariable analysis to determine the factors that are associated with infections 12 months postfracture.MethodsEighteen predictor variables were identified for infection a priori from baseline data, fracture characteristics, and surgical data from the Fluid Lavage of Open Wounds trial. Twelve predictor variables were identified for deep infection, which included both surgically and nonoperatively managed infections. We used multivariable Cox proportional hazards regression analyses to identify the factors associated with infection. Irrigation solution and pressure were included as variables in the analysis. The results were reported as adjusted hazard ratios (HRs), 95% confidence intervals (CIs), and associated P values. All tests were two tailed with alpha = 0.05.ResultsFactors associated with any infection were fracture location (tibia: HR 5.13 versus upper extremity, 95% CI 3.28 to 8.02; other lower extremity: HR 3.63 versus upper extremity, 95% CI 2.38 to 5.55; overall P < 0.001), low energy injury (HR 1.64, 95% CI 1.08 to 2.46; P = 0.019), degree of wound contamination (severe: HR 2.12 versus mild, 95% CI 1.35 to 3.32; moderate: HR 1.08 versus mild, 95% CI 0.78 to 1.49; overall P = 0.004), and need for flap coverage (HR 1.82, 95% CI 1.11 to 2.99; P = 0.017).DiscussionThe results of this study provide a better understanding of which factors are associated with a greater risk of infection in open fractures. In addition, it can allow for surgeons to better counsel patients regarding prognosis, helping patients to understand their individual risk of infection.

Published
2020

18. Health economic evaluation alongside the Probiotics to Prevent Severe Pneumonia and Endotracheal Colonization Trial (E-PROSPECT): a cost-effectiveness analysis

Author

Lau, Vincent I., Xie, Feng, Fowler, Robert A., Rochwerg, Bram, Johnstone, Jennie, Lauzier, François, Marshall, John C., Basmaji, John, Henderson, William, Khwaja, Kosar, Loubani, Osama, Niven, Daniel J., Zarychanski, Ryan, Arabi, Yaseen M., Cartin-Ceba, Rodrigo, Thabane, Lehana, Heels-Ansdell, Diane, and Cook, Deborah J.

Published
2022
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19. Definitions, rates and associated mortality of ICU-acquired pneumonia: A multicenter cohort study

Author

Johnstone, Jennie, Muscedere, John, Dionne, Joanna, Duan, Erick, Rochwerg, Bram, Centofanti, John, Oczkowski, Simon, Lauzier, Francois, Marshall, John, Heels-Ansdell, Diane, Daneman, Nick, Mehta, Sangeeta, Arabi, Yaseen, Zytaruk, Nicole, Dodek, Peter, Adhikari, Neill K., Karachi, Tim, Charbonney, Emmanuel, Stelfox, Henry T., Kristof, Arnold S., Ball, Ian, Hand, Lori, Fowler, Rob, Zarychanski, Ryan, Arnaud, Charles St, Takaoka, Alyson, Kutsogiannis, James, Khwaja, Kosar, Sligl, Wendy, Loubani, Osama, Tsang, Jennifer, Lamarche, Daphnee, Bowdish, Dawn, Surette, Michael, and Cook, Deborah

Published
2023
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21. The impact of heterotopic ossification prophylaxis after surgical fixation of acetabular fractures: national treatment patterns and related outcomes

Author

Slobogean, Gerard P., Sprague, Sheila, Wells, Jeffrey, Bhandari, Mohit, Harris, Anthony D., Mullins, C. Daniel, Thabane, Lehana, Wood, Amber, Rocca, Gregory J. Della, Hebden, Joan, Jeray, Kyle J., Marchand, Lucas S., O'Hara, Lyndsay M., Zura, Robert, Lee, Christopher, Patterson, Joseph, Gardner, Michael J., Blasman, Jenna, Davies, Jonah, Liang, Stephen, Taljaard, Monica, Devereaux, PJ, Guyatt, Gordon H., Heels-Ansdell, Diane, Marvel, Debra, Wells, Jana Palmer Jeffrey, Friedrich, Jeff, O'Hara, Nathan N., Grissom, Frances, Gitajn, I. Leah, Morshed, Saam, O'Toole, Robert V., Petrisor, Bradley A., Mossuto, Franca, Joshi, Manjari G., D'Alleyrand, Jean-Claude, Fowler, Justin, Rivera, Jessica, Talbot, Max, Pogorzelski, David, Dodds, Shannon, Li, Silvia, Rojas, Alejandra, Fabbro, Gina Del, Szasz, Olivia Paige, McKay, Paula, Minea, Alexandra, Howe, Andrea, Demyanovich, Haley, Medeiros, Michelle, Polk, Genevieve, Kettering, Eric, Mahal, Nirmen, Eglseder, Andrew, Johnson, Aaron, Langhammer, Christopher, Lebrun, Christopher, Nascone, Jason, Pensy, Raymond, Pollak, Andrew, Sciadini, Marcus, Degani, Yasmin, Demyanovich, Haley K., Phipps, Heather, Hempen, Eric, Holler, Christine, Petrisor, Brad A., Johal, Herman, Ristevski, Bill, Williams, Dale, Denkers, Matthew, Rajaratnam, Krishan, Al-Asiri, Jamal, Gallant, Jodi, Pusztai, Kaitlyn, MacRae, Sarah, Renaud, Sara, Adams, John D., Beckish, Michael L., Bray, Christopher C., Brown, Timothy R., Cross, Andrew W., Dew, Timothy, Faucher, Gregory K., Gurich, Richard W., Jr, Lazarus, David E., Millon, S. John, Moody, M. Christian, Palmer, M. Jason, Porter, Scott E., Schaller, Thomas M., Sridhar, Michael S., Sanders, John L., Rudisill, L. Edwin, Jr, Garitty, Michael J., Poole, Andrew S., Sims, Michael L., Walker, Clark M., Carlisle, Robert, Hofer, Erin A., Huggins, Brandon, Hunter, Michael, Marshall, William, Ray, Shea B., Smith, Cory, Altman, Kyle M., Pichiotino, Erin, Quirion, Julia C., Loeffler, Markus F., Pichiotino, Erin R., Cole, Austin A., Maltz, Ethan J., Parker, Wesley, Ramsey, T. Bennett, Burnikel, Alex, Colello, Michael, Stewart, Russell, Wise, Jeremy, Anderson, Matthew, Eskew, Joshua, Judkins, Benjamin, Miller, James M., Tanner, Stephanie L., Snider, Rebecca G., Townsend, Christine E., Pham, Kayla H., Martin, Abigail, Robertson, Emily, Bray, Emily, Sykes, J. Wilson, Yoder, Krystina, Conner, Kelsey, Abbott, Harper, Natoli, Roman M., McKinley, Todd O., Virkus, Walter W., Sorkin, Anthony T., Szatkowski, Jan P., Mullis, Brian H., Jang, Yohan, Lopas, Luke A., Hill, Lauren C., Fentz, Courteney L., Diaz, Maricela M., Brown, Krista, Garst, Katelyn M., Denari, Emma W., Osborn, Patrick, Pierrie, Sarah, Herrera, Maria, Miclau, Theodore, Marmor, Meir, Matityahu, Amir, McClellan, R. Trigg, Shearer, David, Toogood, Paul, Ding, Anthony, Murali, Jothi, Naga, Ashraf El, Tangtiphaiboontana, Jennifer, Belaye, Tigist, Berhaneselase, Eleni, Pokhvashchev, Dmitry, Obremskey, William T, Jahangir, Amir Alex, Sethi, Manish, Boyce, Robert, Stinner, Daniel J., Mitchell, Phillip, Trochez, Karen, Rodriguez, Elsa, Pritchett, Charles, Hogan, Natalie, Moreno, A. Fidel, Hagen, Jennifer E., Patrick, Matthew, Vlasak, Richard, Krupko, Thomas, Talerico, Michael, Horodyski, Marybeth, Pazik, Marissa, Lossada-Soto, Elizabeth, Gary, Joshua L., Warner, Stephen J, Munz, John W., Choo, Andrew M., Achor, Timothy S., Routt, Milton L. “Chip”, Kutzler, Michael, Boutte, Sterling, Warth, Ryan J., Prayson, Michael, Venkatarayappa, Indresh, Horne, Brandon, Jerele, Jennifer, Clark, Linda, Boulton, Christina, Lowe, Jason, Ruth, John T., Askam, Brad, Seach, Andrea, Cruz, Alejandro, Featherston, Breanna, Carlson, Robin, Romero, Iliana, Zarif, Isaac, Dehghan, Niloofar, McKee, Michael, Jones, Clifford B, Sietsema, Debra L, Williams, Alyse, Dykes, Tayler, Guerra-Farfan, Ernesto, Tomas-Hernandez, Jordi, Teixidor-Serra, Jordi, Molero-Garcia, Vicente, Selga-Marsa, Jordi, Porcel-Vazquez, Juan Antonio, Andres-Peiro, Jose Vicente, Esteban-Feliu, Ignacio, Vidal-Tarrason, Nuria, Serracanta, Jordi, Nuñez-Camarena, Jorge, del Mar Villar-Casares, Maria, Mestre-Torres, Jaume, Lalueza-Broto, Pilar, Moreira-Borim, Felipe, Garcia-Sanchez, Yaiza, Marcano-Fernández, Francesc, Martínez-Carreres, Laia, Martí-Garín, David, Serrano-Sanz, Jorge, Sánchez-Fernández, Joel, Sanz-Molero, Matsuyama, Carballo, Alejandro, Pelfort, Xavier, Acerboni-Flores, Francesc, Alavedra-Massana, Anna, Anglada-Torres, Neus, Berenguer, Alexandre, Cámara-Cabrera, Jaume, Caparros-García, Ariadna, Fillat-Gomà, Ferran, Fuentes-López, Ruben, Garcia-Rodriguez, Ramona, Gimeno-Calavia, Nuria, Martínez-Álvarez, Marta, Martínez-Grau, Patricia, Pellejero-García, Raúl, Ràfols-Perramon, Ona, Peñalver, Juan Manuel, Domènech, Mònica Salomó, Soler-Cano, Albert, Velasco-Barrera, Aldo, Yela-Verdú, Christian, Bueno-Ruiz, Mercedes, Sánchez-Palomino, Estrella, Andriola, Vito, Molina-Corbacho, Matilde, Maldonado-Sotoca, Yeray, Gasset-Teixidor, Alfons, Blasco-Moreu, Jorge, Fernández-Poch, Núria, Rodoreda-Puigdemasa, Josep, Verdaguer-Figuerola, Arnau, Cueva-Sevieri, Heber Enrique, Garcia-Gimenez, Santiago, Viskontas, Darius G., Apostle, Kelly L., Boyer, Dory S., Moola, Farhad O., Perey, Bertrand H., Stone, Trevor B., Lemke, H. Michael, Spicer, Ella, Payne, Kyrsten, Hymes, Robert A., Schwartzbach, Cary C., Schulman, Jeff E., Malekzadeh, A. Stephen, Holzman, Michael A., Gaski, Greg E., Wills, Jonathan, Pilson, Holly, Carroll, Eben A., Halvorson, Jason J., Babcock, Sharon, Goodman, J. Brett, Holden, Martha B., Williams, Wendy, Hill, Taylor, Brotherton, Ariel, Romeo, Nicholas M., Vallier, Heather A, Vergon, Anna, Higgins, Thomas F., Haller, Justin M., Rothberg, David L., Olsen, Zachary M., McGowan, Abby V., Hill, Sophia, Dauk, Morgan K., Bergin, Patrick F., Russell, George V., Graves, Matthew L., Morellato, John, McGee, Sheketha L., Bhanat, Eldrin L., Yener, Ugur, Khanna, Rajinder, Nehete, Priyanka, Potter, Dr. David, VanDemark, Dr. Robert, III, Seabold, Kyle, Staudenmier, Nicholas, Coe, Marcus, Dwyer, Kevin, Mullin, Devin S., Chockbengboun, Theresa A., DePalo, Peter A., Sr., Phelps, Kevin, Bosse, Michael, Karunakar, Madhav, Kempton, Laurence, Sims, Stephen, Hsu, Joseph, Seymour, Rachel, Churchill, Christine, Mayfield, Ada, Sweeney, Juliette, Jaeblon, Todd, Beer, Robert, Bauer, Brent, Meredith, Sean, Talwar, Sneh, Domes, Christopher M., Gage, Mark J., Reilly, Rachel M., Paniagua, Ariana, Dupree, JaNell, Weaver, Michael J., von Keudell, Arvind G., Sagona, Abigail E., Mehta, Samir, Donegan, Derek, Horan, Annamarie, Dooley, Mary, Heng, Marilyn, Harris, Mitchel B., Lhowe, David W., Esposito, John G., Alnasser, Ahmad, Shannon, Steven F., Scott, Alesha N., Clinch, Bobbi, Weber, Becky, Beltran, Michael J., Archdeacon, Michael T., Sagi, Henry Claude, Wyrick, John D., Le, Theodore Toan, Laughlin, Richard T., Thomson, Cameron G., Hasselfeld, Kimberly, Lin, Carol A., Vrahas, Mark S., Moon, Charles N., Little, Milton T., Marecek, Geoffrey S., Dubuclet, Denice M., Scolaro, John A., Learned, James R., Lim, Philip K., Demas, Susan, Amirhekmat, Arya, Dela Cruz, Yan Marco, Boissonneault, Adam, O Hara, Nathan, Marchand, Lucas, Higgins, Thomas, Gitajn, Leah, Sharma, Ishani, O’Toole, Robert V, and Slobogean, Gerard

Published
2023
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22. Fixation using alternative implants for the treatment of hip fractures (FAITH-2): design and rationale for a pilot multi-centre 2 × 2 factorial randomized controlled trial in young femoral neck fracture patients

Author

Slobogean, Gerard P, Sprague, Sheila, Bzovsky, Sofia, Heels-Ansdell, Diane, Thabane, Lehana, Scott, Taryn, and Bhandari, Mohit

Subjects
Allied Health and Rehabilitation Science, Health Sciences, Osteoporosis, Clinical Research, Complementary and Integrative Health, Clinical Trials and Supportive Activities, Nutrition, Physical Injury - Accidents and Adverse Effects, Aging, 6.1 Pharmaceuticals, 6.4 Surgery, Evaluation of treatments and therapeutic interventions, Injuries and accidents, Musculoskeletal, FAITH-2 Investigators, Clinical protocols, Femoral neck fractures, Fracture fixation, internal, Randomized controlled trial, Vitamin D, Health services and systems
Abstract

BackgroundFemoral neck fractures in patients ≤ 60 years of age are often very different injuries compared to low-energy, hip fractures in elderly patients and are difficult to manage because of inherent problems associated with high-energy trauma mechanisms and increased functional demands for recovery. Internal fixation, with multiple cancellous screws or a sliding hip screw (SHS), is the most common treatment for this injury in young patients. However, there is no clinical consensus regarding which surgical technique is optimal. Additionally, there is compelling rationale to use vitamin D supplementation to nutritionally optimize bone healing in young patients. This pilot trial will determine feasibility and provide preliminary clinical data for a larger definitive trial.MethodsWe will conduct a multicenter, concealed randomized controlled pilot study, using a 2 × 2 factorial design in 60 patients aged 18-60 years with a femoral neck fracture. Eligible patients will be randomized in equal proportions to one of four groups: 1) SHS and vitamin D supplementation (4000 international units (IU) daily dose) for 6 months, 2) cancellous screws and vitamin D supplementation (4000 IU daily dose) for 6 months, 3) SHS and placebo, and 4) cancellous screws and placebo. Participants will be followed for 12 months post-fracture. Feasibility outcomes include initiation of clinical sites, recruitment, follow-up, data quality, and protocol adherence. Clinical outcomes, for both the pilot and planned definitive trials, include a composite of patient-important outcomes (re-operation, femoral head osteonecrosis, severe femoral neck malunion, and nonunion), health-related quality of life and patient-reported function, fracture healing complications, and radiographic fracture healing. A priori success criteria have been established. If the pilot study is deemed successful, study participants will be included in the definitive trial and clinical outcomes for the pilot will not be analyzed. If the pilot study is not deemed successful, clinical outcome data will be analyzed.DiscussionResults of this study will inform the feasibility of a definitive trial. If clinical outcome data are analyzed, they will be disseminated through a publication and presentations.Trial registrationThe FAITH-2 trial, described as a definitive trial, was registered at ClinicalTrials.gov (NCT01908751) prior to enrollment of the first participant.

Published
2019

23. Early In-Bed Cycle Ergometry in Mechanically Ventilated Patients

Author

Kho, Michelle E., primary, Berney, Susan, additional, Pastva, Amy M., additional, Kelly, Laurel, additional, Reid, Julie C., additional, Burns, Karen E. A., additional, Seely, Andrew J., additional, D’Aragon, Frédérick, additional, Rochwerg, Bram, additional, Ball, Ian, additional, Fox-Robichaud, Alison E., additional, Karachi, Tim, additional, Lamontagne, Francois, additional, Archambault, Patrick M., additional, Tsang, Jennifer L., additional, Duan, Erick H., additional, Muscedere, John, additional, Verceles, Avelino C., additional, Serri, Karim, additional, English, Shane W., additional, Reeve, Brenda K., additional, Mehta, Sangeeta, additional, Rudkowski, Jill C., additional, Heels-Ansdell, Diane, additional, O’Grady, Heather K., additional, Strong, Geoff, additional, Obrovac, Kristy, additional, Ajami, Daana, additional, Camposilvan, Laura, additional, Tarride, Jean-Eric, additional, Thabane, Lehana, additional, Herridge, Margaret S., additional, and Cook, Deborah J., additional

Published
2024
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24. The relative merits of using a high-sensitivity cardiac Troponin T assay compared to a non-high-sensitivity Troponin T assay after noncardiac surgery

Author

Borges, Flavia K., primary, Sessler, Daniel I., additional, Tiboni, Maria, additional, Patel, Ameen, additional, LeManach, Yannick, additional, Heels-Ansdell, Diane, additional, Srinathan, Sadeesh, additional, Wang, Chew Yin, additional, Chow, Clara, additional, Duceppe, Emmanuelle, additional, Kavsak, Peter, additional, Ofori, Sandra N., additional, Pettit, Shirley, additional, Berwanger, Otavio, additional, Kurz, Andrea, additional, Turan, Alparslan, additional, Tonelli, Ana Claudia, additional, and Devereaux, PJ, additional

Published
2024
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25. Aqueous skin antisepsis before surgical fixation of open fractures (Aqueous-PREP): a multiple-period, cluster-randomised, crossover trial

Author

Slobogean, Gerard P., Sprague, Sheila, Wells, Jeffrey L., Bhandari, Mohit, Harris, Anthony D., Mullins, C. Daniel, Thabane, Lehana, Wood, Amber, Della Rocca, Gregory J., Hebden, Joan N., Jeray, Kyle J., Marchand, Lucas S., O'Hara, Lyndsay M., Zura, Robert D., Lee, Christopher, Patterson, Joseph T., Gardner, Michael J., Blasman, Jenna, Davies, Jonah, Liang, Stephen, Taljaard, Monica, Devereaux, PJ, Guyatt, Gordon, Heels-Ansdell, Diane, Marvel, Debra, Palmer, Jana E., Friedrich, Jeff, O'Hara, Nathan N., Grissom, Frances, Gitajn, I. Leah, Morshed, Saam, O'Toole, Robert V., Petrisor, Bradley, Mossuto, Franca, Joshi, Manjari G., D'Alleyrand, Jean-Claude G., Fowler, Justin, Rivera, Jessica C., Talbot, Max, Pogorzelski, David, Dodds, Shannon, Li, Silvia, Del Fabbro, Gina, Szasz, Olivia Paige, Bzovsky, Sofia, McKay, Paula, Minea, Alexandra, Murphy, Kevin, Howe, Andrea L., Demyanovich, Haley K., Hoskins, Wayne, Medeiros, Michelle, Polk, Genevieve, Kettering, Eric, Mahal, Nirmen, Eglseder, Andrew, Johnson, Aaron, Langhammer, Christopher, Lebrun, Christopher, Nascone, Jason, Pensy, Raymond, Pollak, Andrew, Sciadini, Marcus, Degani, Yasmin, Phipps, Heather, Hempen, Eric, Johal, Herman, Ristevski, Bill, Williams, Dale, Denkers, Matthew, Rajaratnam, Krishan, Al-Asiri, Jamal, Gallant, Jodi L., Pusztai, Kaitlyn, MacRae, Sarah, Renaud, Sara, Adams, John D., Beckish, Michael L., Bray, Christopher C., Brown, Timothy R., Cross, Andrew W., Dew, Timothy, Faucher, Gregory K., Gurich Jr, Richard W., Lazarus, David E., Millon, S. John, Moody, M. Christian, Palmer, M. Jason, Porter, Scott E., Schaller, Thomas M., Sridhar, Michael S., Sanders, John L., Rudisill Jr, L. Edwin, Garitty, Michael J., Poole, Andrew S., Sims, Michael L., Walker, Clark M., Carlisle, Robert, Hofer, Erin A., Huggins, Brandon, Hunter, Michael, Marshall, William, Ray, Shea B., Smith, Cory, Altman, Kyle M., Pichiotino, Erin R., Quirion, Julia C., Loeffler, Markus F., Cole, Austin A., Maltz, Ethan J., Parker, Wesley, Ramsey, T. Bennett, Burnikel, Alex, Colello, Michael, Stewart, Russell, Wise, Jeremy, Anderson, Matthew, Eskew, Joshua, Judkins, Benjamin, Miller, James M., Tanner, Stephanie L., Snider, Rebecca G., Townsend, Christine E., Pham, Kayla H., Martin, Abigail, Robertson, Emily, Bray, Emily, Sykes, J. Wilson, Yoder, Krystina, Conner, Kelsey, Abbott, Harper, Natoli, Roman M., McKinley, Todd O., Virkus, Walter W., Sorkin, Anthony T., Szatkowski, Jan P., Mullis, Brian H., Jang, Yohan, Lopas, Luke A., Hill, Lauren C., Fentz, Courteney L., Diaz, Maricela M., Brown, Krista, Garst, Katelyn M., Denari, Emma W., Osborn, Patrick, Pierrie, Sarah N., Kessler, Bradley, Herrera, Maria, Miclau, Theodore, Marmor, Meir T., Matityahu, Amir, McClellan, R. Trigg, Shearer, David, Toogood, Paul, Ding, Anthony, Murali, Jothi, El Naga, Ashraf, Tangtiphaiboontana, Jennifer, Belaye, Tigist, Berhaneselase, Eleni, Pokhvashchev, Dmitry, Obremskey, William T., Jahangir, Amir Alex, Sethi, Manish, Boyce, Robert, Stinner, Daniel J., Mitchell, Phillip P., Trochez, Karen, Rodriguez, Elsa, Pritchett, Charles, Hogan, Natalie, Fidel Moreno, A., Hagen, Jennifer E., Patrick, Matthew, Vlasak, Richard, Krupko, Thomas, Talerico, Michael, Horodyski, Marybeth, Pazik, Marissa, Lossada-Soto, Elizabeth, Gary, Joshua L., Warner, Stephen J., Munz, John W., Choo, Andrew M., Achor, Timothy S., Routt, Milton L. “Chip”, Kutzler, Michael, Boutte, Sterling, Warth, Ryan J., Prayson, Michael J., Venkatarayappa, Indresh, Horne, Brandon, Jerele, Jennifer, Clark, Linda, Boulton, Christina, Lowe, Jason, Ruth, John T., Askam, Brad, Seach, Andrea, Cruz, Alejandro, Featherston, Breanna, Carlson, Robin, Romero, Iliana, Zarif, Isaac, Dehghan, Niloofar, McKee, Michael, Jones, Clifford B., Sietsema, Debra L., Williams, Alyse, Dykes, Tayler, Guerra-Farfan, Ernesto, Tomas-Hernandez, Jordi, Teixidor-Serra, Jordi, Molero-Garcia, Vicente, Selga-Marsa, Jordi, Porcel-Vazquez, Juan Antonio, Andres-Peiro, Jose Vicente, Esteban-Feliu, Ignacio, Vidal-Tarrason, Nuria, Serracanta, Jordi, Nuñez-Camarena, Jorge, del Mar Villar-Casares, Maria, Mestre-Torres, Jaume, Lalueza-Broto, Pilar, Moreira-Borim, Felipe, Garcia-Sanchez, Yaiza, Marcano-Fernández, Francesc, Martínez-Carreres, Laia, Martí-Garín, David, Serrano-Sanz, Jorge, Sánchez-Fernández, Joel, Sanz-Molero, Matsuyama, Carballo, Alejandro, Pelfort, Xavier, Acerboni-Flores, Francesc, Alavedra-Massana, Anna, Anglada-Torres, Neus, Berenguer, Alexandre, Cámara-Cabrera, Jaume, Caparros-García, Ariadna, Fillat-Gomà, Ferran, Fuentes-López, Ruben, Garcia-Rodriguez, Ramona, Gimeno-Calavia, Nuria, Martínez-Álvarez, Marta, Martínez-Grau, Patricia, Pellejero-García, Raúl, Ràfols-Perramon, Ona, Peñalver, Juan Manuel, Salomó Domènech, Mònica, Soler-Cano, Albert, Velasco-Barrera, Aldo, Yela-Verdú, Christian, Bueno-Ruiz, Mercedes, Sánchez-Palomino, Estrella, Andriola, Vito, Molina-Corbacho, Matilde, Maldonado-Sotoca, Yeray, Gasset-Teixidor, Alfons, Blasco-Moreu, Jorge, Fernández-Poch, Núria, Rodoreda-Puigdemasa, Josep, Verdaguer-Figuerola, Arnau, Cueva-Sevieri, Heber Enrique, Garcia-Gimenez, Santiago, Viskontas, Darius G., Apostle, Kelly L., Boyer, Dory S., Moola, Farhad O., Perey, Bertrand H., Stone, Trevor B., Lemke, H. Michael, Spicer, Ella, Payne, Kyrsten, Hymes, Robert A., Schwartzbach, Cary C., Schulman, Jeff E., Malekzadeh, A. Stephen, Holzman, Michael A., Gaski, Greg E., Wills, Jonathan, Pilson, Holly, Carroll, Eben A., Halvorson, Jason J., Babcock, Sharon, Goodman, J. Brett, Holden, Martha B., Williams, Wendy, Hill, Taylor, Brotherton, Ariel, Romeo, Nicholas M., Vallier, Heather A., Vergon, Anna, Higgins, Thomas F., Haller, Justin M., Rothberg, David L., Olsen, Zachary M., McGowan, Abby V., Hill, Sophia, Dauk, Morgan K., Bergin, Patrick F., Russell, George V., Graves, Matthew L., Morellato, John, McGee, Sheketha L., Bhanat, Eldrin L., Yener, Ugur, Khanna, Rajinder, Nehete, Priyanka, Potter, David, VanDemark III, Robert, Seabold, Kyle, Staudenmier, Nicholas, Coe, Marcus, Dwyer, Kevin, Mullin, Devin S., Chockbengboun, Theresa A., DePalo Sr., Peter A., Phelps, Kevin, Bosse, Michael, Karunakar, Madhav, Kempton, Laurence, Sims, Stephen, Hsu, Joseph, Seymour, Rachel, Churchill, Christine, Mayfield, Ada, Sweeney, Juliette, Jaeblon, Todd, Beer, Robert, Bauer, Brent, Meredith, Sean, Talwar, Sneh, Domes, Christopher M., Gage, Mark J., Reilly, Rachel M., Paniagua, Ariana, Dupree, JaNell, Weaver, Michael J., von Keudell, Arvind G., Sagona, Abigail E., Mehta, Samir, Donegan, Derek, Horan, Annamarie, Dooley, Mary, Heng, Marilyn, Harris, Mitchel B., Lhowe, David W., Esposito, John G., Alnasser, Ahmad, Shannon, Steven F., Scott, Alesha N., Clinch, Bobbi, Weber, Becky, Beltran, Michael J., Archdeacon, Michael T., Sagi, Henry Claude, Wyrick, John D., Le, Theodore Toan, Laughlin, Richard T., Thomson, Cameron G., Hasselfeld, Kimberly, Lin, Carol A., Vrahas, Mark S., Moon, Charles N., Little, Milton T., Marecek, Geoffrey S., Dubuclet, Denice M., Scolaro, John A., Learned, James R., Lim, Philip K., Demas, Susan, Amirhekmat, Arya, and Dela Cruz, Yan Marco

Published
2022
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27. Association of Preoperative Growth Differentiation Factor-15 Concentrations and Postoperative Cardiovascular Events after Major Noncardiac Surgery

Author

Duceppe, Emmanuelle, Borges, Flavia K., Conen, David, Tiboni, Maria, Chan, Matthew T. V., Patel, Ameen, Sessler, Daniel I., Kavsak, Peter A., Ofori, Sandra, Srinathan, Sadeesh, Pearse, Rupert, Jaffe, Allan S., Heels-Ansdell, Diane, Garg, Amit X., Pettit, Shirley, Sapsford, Robert, and Devereaux, P. J.

Published
2023
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29. Osteochondroplasty Benefits the Pragmatic Patient With Femoroacetabular Impingement: Analysis From the Embedded Prospective Cohort of the Femoroacetabular Impingement RandomiSed Controlled Trial (FIRST)

Author

Ayeni, Olufemi R., Bhandari, Mohit, Bedi, Asheesh, Järvinen, Teppo, Musahl, Volker, Naudie, Douglas, Seppänen, Matti, Slobogean, Gerard, Thabane, Lehana, Simunovic, Nicole, Duong, Andrew, Skelly, Matthew, Shanmugaraj, Ajay, Crouch, Sarah, Sprague, Sheila, Heels-Ansdell, Diane, Buckingham, Lisa, Ramsay, Tim, Lee, John, Kousa, Petteri, Carsen, Sasha, Choudur, Hema, Sim, Yan, Johnston, Kelly, Wong, Ivan, Murphy, Ryland, Sparavalo, Sara, Whelan, Daniel, Khan, Ryan, Wood, Gavin C.A., Howells, Fiona, Grant, Heather, Zomar, Bryn, Pollock, Michael, Willits, Kevin, Firth, Andrew, Wanlin, Stacey, Remtulla, Alliya, Kaniki, Nicole, Belzile, Etienne L., Turmel, Sylvie, Jørgensen, Uffe, Gam-Pedersen, Annie, Hatanpää, Tays, Sihvonen, Raine, Raivio, Marko, Toivonen, Pirjo, Routapohja, Mari Pirjetta, Almasri, Mahmoud, and Ayenil, Olufemi R.

Published
2022
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30. Proton pump inhibitors for gastrointestinal bleeding prophylaxis in critically ill patients: A systematic review protocol.

Author

Wang, Ying, Heels‐Ansdell, Diane, Ge, Long, Parpia, Sameer, Ibrahim, Quazi, Cook, Deborah, Deane, Adam, Lauzier, Francois, Hammond, Naomi, Møller, Morten H., Krag, Mette, Perner, Anders, and Guyatt, Gordon H.

Subjects
*PROTON pump inhibitors, *GASTROINTESTINAL hemorrhage, *CRITICALLY ill, *PREVENTIVE medicine, *CLOSTRIDIOIDES difficile
Abstract

Background: Proton pump inhibitors (PPIs) are the most commonly prescribed drugs for preventing upper gastrointestinal bleeding in critically ill patients. However, concerns have arisen about the possible harms of using PPIs, including potentially increased risk of pneumonia, Clostridioides difficile infection, and more seriously, an increased risk of death in the most severely ill patients. Triggered by the REVISE trial, which is a forthcoming large randomized trial comparing pantoprazole to placebo in invasively mechanically ventilated patients, we will conduct this systematic review to evaluate the efficacy and safety of PPIs versus no prophylaxis for critically ill patients. Methods: We will systematically search randomized trials that compared gastrointestinal bleeding prophylaxis with PPIs versus placebo or no prophylaxis in adults in the intensive care unit (ICU). Pairs of reviewers will independently screen the literature, and for those eligible trials, extract data and assess risk of bias. We will perform meta‐analyses using a random‐effects model, and calculate relative risks for dichotomous outcomes and mean differences for continuous outcomes, and the associated 95% confidence intervals. We will conduct subgroup analysis to explore whether the impact of PPIs on mortality differs in more and less severely ill patients. We will assess certainty of evidence using the GRADE approach. Discussion: This systematic review will provide the most up‐to‐date evidence regarding the merits and limitations of stress ulcer prophylaxis with PPIs in critically ill patients in contemporary practice. [ABSTRACT FROM AUTHOR]

Published
2024
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31. Proton-Pump Inhibitors to Prevent Gastrointestinal Bleeding -- An Updated Meta-Analysis.

Author

Ying Wang, Parpia, Sameer, Long Ge, Heels-Ansdell, Diane, Honghao Lai, Esfahani, Meisam Abdar, Bei Pan, Alhazzani, Waleed, Schandelmaier, Stefan, Lauzier, Francois, Arabi, Yaseen, Barletta, Jeffrey, Deane, Adam, Finfer, Simon, Williamson, David, Kanji, Salmaan, Møller, Morten H., Perner, Anders, Krag, Mette, and Young, Paul J.

Subjects
PATIENT safety, GASTROINTESTINAL hemorrhage, PEPTIC ulcer, TREATMENT effectiveness, META-analysis, SEVERITY of illness index, RELATIVE medical risk, PRE-exposure prophylaxis, PROTON pump inhibitors, CONFIDENCE intervals, CRITICALLY ill patient psychology
Abstract

Background: The goal of this systematic review was to examine the efficacy and safety of proton-pump inhibitors for stress ulcer prophylaxis in critically ill patients. Methods: We included randomized trials comparing proton-pump inhibitors versus placebo or no prophylaxis in critically ill adults, performed meta-analyses, and assessed certainty of evidence using the Grading of Recommendations, Assessment, Development, and Evaluations approach. To explore the effect of proton-pump inhibitors on mortality based on disease severity, a subgroup analysis was conducted combining within-trial subgroup data from the two largest trials and assessed credibility using the Instrument for Assessing the Credibility of Effect Modification Analyses. Results: Twelve trials that enrolled 9533 patients were included. Proton-pump inhibitors were associated with a reduced incidence of clinically important upper gastrointestinal bleeding (relative risk [RR], 0.51 [95% confidence interval (CI), 0.34 to 0.76]; high certainty evidence). Proton-pump inhibitors may have little or no effect on mortality (RR, 0.99 [95% CI, 0.93 to 1.05]; low certainty). Within-trial subgroup analysis with intermediate credibility suggested that the effect of proton-pump inhibitors on mortality may differ based on disease severity. Subgroup results raise the possibility that proton-pump inhibitors may decrease 90-day mortality in less severely ill patients (RR, 0.89; 95% CI, 0.80 to 0.98) and may increase mortality in more severely ill patients (RR, 1.08; 95% CI, 0.96 to 1.20]. Proton-pump inhibitors may have no effect on pneumonia and little or no effect on Clostridioides difficile infection (low certainty). Conclusions: High certainty evidence supports the association of proton-pump inhibitors with decreased upper gastrointestinal bleeding. Proton-pump inhibitors may have little or no effect on mortality, although a decrease in mortality in less severely ill patients and an increase in mortality in more severely ill patients remain possible. (PROSPERO number CRD42023461695.) [ABSTRACT FROM AUTHOR]

Published
2024
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33. Impact of centre volume, surgeon volume, surgeon experience and geographic location on reoperation after intramedullary nailing of tibial shaft fractures

Author

Swiontkowski, Marc, Teague, David, Sprague, Sheila, Bzovsky, Sofia, Heels-Ansdell, Diane, Bhandari, Mohit, Schemitsch, Emil H., Sanders, David W., Tornetta, Paul, III, and Walter, Stephen D.

Subjects
Leg -- Injuries, Internal fixation in fractures -- Statistics -- Patient outcomes, Surgeons -- Statistics -- Supply and demand, Reoperation -- Statistics -- Patient outcomes, Health, Health care industry
Abstract

Background: Tibial shaft fractures are the most common long-bone injury, with a reported annual incidence of more than 75 000 in the United States. This study aimed to determine whether patients with tibial fractures managed with intramedullary nails experience a lower rate of reoperation if treated at higher-volume hospitals, or by higher-volume or more experienced surgeons. Methods: The Study to Prospectively Evaluate Reamed Intramedullary Nails in Patients with Tibial Fractures (SPRINT) was a multicentre randomized clinical trial comparing reamed and nonreamed intramedullary nailing on rates of reoperation to promote fracture union, treat infection or preserve the limb in patients with open and closed fractures of the tibial shaft. Using data from SPRINT, we quantified centre and surgeon volumes into quintiles. We performed analyses adjusted for type of fracture (open v. closed), type of injury (isolated v. multitrauma), gender and age for the primary outcome of reoperation using multivariable logistic regression. Results: There were no significant differences in the odds of reoperation between high-and low-volume centres (p = 0.9). Overall, surgeon volume significantly affected the odds of reoperation (p = 0.03). The odds of reoperation among patients treated by moderate-volume surgeons were 50% less than those among patients treated by very-low-volume surgeons (odds ratio [OR] 0.50, 95% confidence interval [CI] 0.28-0.88), and the odds of reoperation among patients treated by high-volume surgeons were 47% less than those among patients treated by very-low-volume surgeons (OR 0.53, 95% CI 0.30-0.93). Conclusion: There appears to be no significant additional patient benefit in treatment by a higher-volume centre for intramedullary fixation of tibial shaft fractures. Additional research on the effects of surgical and clinical site volume in tibial shaft fracture management is needed to confirm this finding. The odds of reoperation were higher in patients treated by very-low-volume surgeons; this finding may be used to optimize the results of tibial shaft fracture management. Clinical trial registration: ClinicalTrials.gov, NCT00038129 Contexte: La fracture de la diaphyse tibiale est la plus commune des fractures des os longs, avec une incidence annuelle declaree de plus 75 000 cas aux Etats-Unis. Cette etude visait a determiner si les patients traites par enclouage intra-medullaire pour une fracture du tibia sont moins souvent reoperes quand l'intervention est effectuee dans des etablissements qui traitent de plus forts volumes de cas ou par des chirurgiens operant un plus fort volume de cas ou plus experimentes. Methodes: L'etude SPRINT (Study to Prospectively Evaluate Reamed Intramedullary Nails in Patients with Tibial Fractures) est un essai clinique multicentrique randomise qui a compare l'effet de l'enclouage alese c. non alese sur le taux des reinterventions visant a promouvoir la consolidation osseuse de la fracture, a traiter une infection ou a preserver le membre chez des patients victimes de fractures fermees ou ouvertes de la diaphyse tibiale. A partir des donnees de l'etude SPRINT, nous avons classe les etablissements et les chirurgiens en quintiles selon les volumes de cas traites. Nous avons effectue des analyses ajustees en fonction du type de fracture (ouverte c. fermee), du type de blessure (isolee c. polytraumatisme), du sexe et de l'age, pour etablir le taux de reintervention (parametre principal), en utilisant la regression logistique multivariee. Resultats: On n'a note aucune difference significative quant au risque de reinter-vention entre les centres qui traitaient des volumes eleves c. bas (p = 0,9). Dans l'ensemble le volume d'operations des chirurgiens a significativement influe sur le risque de reintervention (p = 0,03). Le risque de reintervention chez les patients traites par des chirurgiens dont le volume d'interventions etait moyen etait de 50 % de moins que chez les patients traites par des chirurgiens dont le volume etait tres bas (risque relatif [RR] 0,50, intervalle de confiance [IC] a 95 % 0,28-0,88) et le risque de reinter-vention chez les patients traites par des chirurgiens dont le volume etait tres eleve etait de 47 % de moins que chez les patients traites par des chirurgiens dont le volume etait tres bas (RR 0,53, IC a 95 % 0,30-0,93). Conclusion: Il ne semble y avoir aucun bienfait additionnel significatif au fait d'etre opere dans un centre ou le volume d'interventions pour enclouage intra-medullaire des fractures de la diaphyse tibiale est eleve. Il faudra approfondir la recherche sur les effets du volume chirurgical et de l'experience clinique des etablissements pour confirmer cette observation. Le risque de reintervention a ete plus eleve chez les patients traites par des chirurgiens dont le volume d'interventions etait tres bas; cette observation pourrait etre utilisee pour optimiser l'issue du traite-ment des fractures de la diaphyse tibiale. Enregistrement de l'essai clinique: ClinicalTrials.gov, NCT00038129., Tibial shaft fractures are the most common long-bone injury, with a reported annual incidence of more than 75 000 in the United States. (1) Treatment aims to achieve union of [...]

Published
2021
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34. Drug treatments for covid-19 : living systematic review and network meta-analysis

Author

Siemieniuk, Reed AC, Bartoszko, Jessica J, Ge, Long, Zeraatkar, Dena, Izcovich, Ariel, Kum, Elena, Pardo-Hernandez, Hector, Rochwerg, Bram, Lamontagne, Francois, Han, Mi Ah, Liu, Qin, Agarwal, Arnav, Agoritsas, Thomas, Chu, Derek K, Couban, Rachel, Darzi, Andrea, Devji, Tahira, Fang, Bo, Fang, Carmen, Flottorp, Signe Agnes, Foroutan, Farid, Ghadimi, Maryam, Heels-Ansdell, Diane, Honarmand, Kimia, Hou, Liangying, Hou, Xiaorong, Ibrahim, Quazi, Khamis, Assem, Lam, Bonnie, Loeb, Mark, Marcucci, Maura, McLeod, Shelley L, Motaghi, Sharhzad, Murthy, Srinivas, Mustafa, Reem A, Neary, John D, Qasim, Anila, Rada, Gabriel, Riaz, Irbaz Bin, Sadeghirad, Behnam, Sekercioglu, Nigar, Sheng, Lulu, Sreekanta, Ashwini, Switzer, Charlotte, Tendal, Britta, Thabane, Lehana, Tomlinson, George, Turner, Tari, Vandvik, Per O, Vernooij, RobinWM, Viteri-García, Andrés, Wang, Ying, Yao, Liang, Ye, Zhikang, Guyatt, Gordon H, and Brignardello-Petersen, Romina

Published
2020

35. Implementing stakeholder engagement to explore alternative models of consent: An example from the PREP-IT trials

Author

Slobogean, Gerard P., Bhandari, Mohit, Sprague, Sheila, D'Alleyrand, Jean-Claude, Harris, Anthony D., Mullins, Daniel C., Thabane, Lehana, Wells, Jeffrey, Wood, Amber, Della Rocca, Gregory J., Hebden, Joan, Jeray, Kyle J., Marchand, Lucas, O'Hara, Lyndsay M., Zura, Robert, Gardner, Michael J., Blasman, Jenna, Davies, Jonah, Liang, Stephen, Taljaard, Monica, Devereaux, P.J., Guyatt, Gordon H., Heels-Ansdell, Diane, Marvel, Debra, Palmer, Jana, Friedrich, Jeff, O'Hara, Nathan N., Grissom, Ms Frances, Gitajn, I. Leah, Morshed, Saam, O'Toole, Robert V., Petrisor, Bradley A., Camara, Megan, Mossuto, Franca, Joshi, Manjari G., Fowler, Justin, Rivera, Jessica, Talbot, Max, Dodds, Shannon, Garibaldi, Alisha, Li, Silvia, Nguyen, Uyen, Pogorzelski, David, Rojas, Alejandra, Scott, Taryn, Del Fabbro, Gina, Szasz, Olivia Paige, McKay, Paula, Howe, Andrea, Rudnicki, Joshua, Demyanovich, Haley, Little, Kelly, Mullins, C. Daniel, Medeiros, Michelle, Kettering, Eric, Hale, Diamond, Petrisor, Brad A., Johal, Herman, Ristevski, Bill, Williams, Dale, Denkers, Matthew, Rajaratnam, Krishan, Al-Asiri, Jamal, Leonard, Jordan, Marcano-Fernández, Francesc A., Gallant, Jodi, Persico, Federico, Gjorgjievski, Marko, George, Annie, Natoli, Roman M., Gaski, Greg E., McKinley, Todd O., Virkus, Walter W., Sorkin, Anthony T., Szatkowski, Jan P., Baele, Joseph R., Mullis, Brian H., Hill, Lauren C., Hudgins, Andrea, Osborn, Patrick, Pierrie, Sarah, Martinez, Eric, Kimmel, Joseph, Adams, John D., Beckish, Michael L., Bray, Christopher C., Brown, Timothy R., Cross, Andrew W., Dew, Timothy, Faucher, Gregory K., Gurich, Richard W., Jr., Lazarus, David E., Millon, S. John, Palmer, M. Jason, Porter, Scott E., Schaller, Thomas M., Sridhar, Michael S., Sanders, John L., Rudisill, L. Edwin, Jr., Garitty, Michael J., Poole, Andrew S., Sims, Michael L., Walker, Clark M., Carlisle, Robert M., II, Hofer, Erin Adams, Huggins, Brandon S., Hunter, Michael D., Marshall, William A., Ray, Shea Bielby, Smith, Cory D., Altman, Kyle M., Bedard, Julia C., Loeffler, Markus F., Pichiotino, Erin R., Cole, Austin A., Maltz, Ethan J., Parker, Wesley, Ramsey, T. Bennett, Burnikel, Alex, Colello, Michael, Stewart, Russell, Wise, Jeremy, Moody, M. Christian, Tanner, Stephanie L., Snider, Rebecca G., Townsend, Christine E., Pham, Kayla H., Martin, Abigail, Robertson, Emily, Miclau, Theodore, Kandemir, Utku, Marmor, Meir, Matityahu, Amir, McClellan, R. Trigg, Meinberg, Eric, Shearer, David, Toogood, Paul, Ding, Anthony, Donohoe, Erin, Murali, Jothi, Belaye, Tigist, Berhaneselase, Eleni, Paul, Alexandra, Garg, Kartik, Gary, Joshua L., Warner, Stephen J., Munz, John W., Choo, Andrew M., Achor, Timothy S., “Chip” Routt, Milton L., Rao, Mayank, Pechero, Guillermo, Miller, Adam, Hagen, Jennifer E., Patrick, Matthew, Vlasak, Richard, Krupko, Thomas, Sadasivan, Kalia, Koenig, Chris, Bailey, Daniel, Wentworth, Daniel, Van, Chi, Schwartz, Justin, Dehghan, Niloofar, Jones, Clifford B., Tracy Watson, J., McKee, Michael, Karim, Ammar, Talerico, Michael, Sietsema, Debra L., Williams, Alyse, Dykes, Tayler, Obremskey, William T., Jahangir, Amir Alex, Sethi, Manish, Boyce, Robert, Stinner, Daniel J., Mitchell, Phillip, Trochez, Karen, Rodriguez, Andres, Gajari, Vamshi, Rodriguez, Elsa, Pritchett, Charles, Boulton, Christina, Lowe, Jason, Wild, Jason, Ruth, John T., Taylor, Michel, Seach, Andrea, Saeed, Sabina, Culbert, Hunter, Cruz, Alejandro, Knapp, Thomas, Hurkett, Colin, Lowney, Maya, Prayson, Michael, Venkatarayappa, Indresh, Horne, Brandon, Jerele, Jennifer, Clark, Linda, Marcano-Fernández, Francesc, Jornet-Gibert, Montsant, Martínez-Carreres, Laia, Martí-Garín, David, Serrano-Sanz, Jorge, Sánchez-Fernández, Joel, Sanz-Molero, Matsuyama, Carballo, Alejandro, Pelfort, Xavier, Acerboni-Flores, Francesc, Alavedra-Massana, Anna, Anglada-Torres, Neus, Berenguer, Alexandre, Cámara-Cabrera, Jaume, Caparros-García, Ariadna, Fillat-Gomà, Ferran, Fuentes-López, Ruben, Garcia-Rodriguez, Ramona, Gimeno-Calavia, Nuria, Graells-Alonso, Guillem, Martínez-Álvarez, Marta, Martínez-Grau, Patricia, Pellejero-García, Raúl, Ràfols-Perramon, Ona, Peñalver, Juan Manuel, Domènech, Mònica Salomó, Soler-Cano, Albert, Velasco-Barrera, Aldo, Yela-Verdú, Christian, Bueno-Ruiz, Mercedes, Sánchez-Palomino, Estrella, Guerra-Farfan, Ernesto, Tomas-Hernandez, Jordi, Teixidor-Serra, Jordi, Molero-Garcia, Vicente, Selga-Marsa, Jordi, Porcel-Vasquez, Juan Antonio, Andres-Peiro, Jose Vicente, Minguell-Monyart, Joan, Garcia-Sanchez, Yaiza, Nuñez-Camarena, Jorge, Tauste-Rubio, Eladia, Gonzalez-Amigo, Marta, Romeo, Nicholas M., Vallier, Heather A., Breslin, Mary A., Fraifogl, Joanne, Wilson, Eleanor S., Wadenpfuhl, Leanne K., Halliday, Paul G., Viskontas, Darius G., Apostle, Kelly L., Boyer, Dory S., Moola, Farhad O., Perey, Bertrand H., Stone, Trevor B., Lemke, H. Michael, Zomar, Mauri, Spicer, Ella, Fan, Chen “Brenda”, Payne, Kyrsten, Phelps, Kevin, Bosse, Michael, Karunakar, Madhav, Kempton, Laurence, Sims, Stephen, Hsu, Joseph, Seymour, Rachel, Churchill, Christine, Bartel, Claire, Mayberry, Robert Miles, Brownrigg, Maggie, Girardi, Cara, Mayfield, Ada, Hymes, Robert A., Schwartzbach, Cary C., Schulman, Jeff E., Malekzadeh, A. Stephen, Holzman, Michael A., Ramsey, Lolita, Ahn, James S., Panjshiri, Farhanaz, Das, Sharmistha, English, Antoinisha D., Haaser, Sharon M., Cuff, Jaslynn A.N., Pilson, Holly, Carroll, Eben A., Halvorson, Jason J., Babcock, Sharon, Goodman, J. Brett, Holden, Martha B., Bullard, Debra, Williams, Wendy, Higgins, Thomas F., Haller, Justin M., Rothberg, David L., Marchand, Lucas S., Neese, Ashley, Russell, Mark, Olsen, Zachary M., Coe, Marcus, Dwyer, Kevin, Mullin, Devin S., Reilly, Clifford A., DePalo, Peter, Hall, Amy E., Heng, Marilyn, Harris, Mitchel B., Smith, R. Malcolm, Lhowe, David W., Esposito, John G., Bansal, Mira, Bergin, Patrick F., Russell, George V., Graves, Matthew L., Morellato, John, Champion, Heather K., Johnson, Leslie N., McGee, Sheketha L., Bhanat, Eldrin L., Mehta, Samir, Donegan, Derek, Ahn, Jaimo, Horan, Annamarie, Dooley, Mary, Kuczinski, Ashley, Iwu, Ashley, Potter, David, VanDemark, Robert, III, Pfaff, Branden, Hollinsworth, Troy, Weaver, Michael J., von Keudell, Arvind G., McTague, Michael F., Allen, Elizabeth M., Jaeblon, Todd, Beer, Robert, Demyanovich, Haley K., Gage, Mark J., Reilly, Rachel M., Sparrow, Cindy, Pechero, Guillermo, Jr., Holden, Martha, Wells, Jeff, Eglseder, Andrew, Johnson, Aaron, Langhammer, Christopher, Lebrun, Christopher, Manson, Theodore, Nascone, Jason, Paryavi, Ebrahim, Pensy, Raymond, Pollak, Andrew, Sciadini, Marcus, Degani, Yasmin, and Joseph, Katherine

Published
2021
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36. Managing work flow in high enrolling trials: The development and implementation of a sampling strategy in the PREPARE trial

Author

Slobogean, Gerard P., Sprague, Sheila, Wells, Jeffrey, Bhandari, Mohit, D'Alleyrand, Jean-Claude, Harris, Anthony D., Mullins, Daniel C., Thabane, Lehana, Wood, Amber, Della Rocca, Gregory J., Hebden, Joan, Jeray, Kyle J., Marchand, Lucas, O'Hara, Lyndsay M., Zura, Robert, Gardner, Michael J., Blasman, Jenna, Davies, Jonah, Liang, Stephen, Taljaard, Monica, Devereaux, P.J., Guyatt, Gordon H., Heels-Ansdell, Diane, Marvel, Debra, Palmer, Jana, Friedrich, Jeff, O'Hara, Nathan N., Grissom, Ms. Frances, Gitajn, I. Leah, Morshed, Saam, O'Toole, Robert V., Petrisor, Bradley A., Camara, Megan, Mossuto, Franca, Joshi, Manjari G., Fowler, Justin, Rivera, Jessica, Talbot, Max, Dodds, Shannon, Garibaldi, Alisha, Li, Silvia, Nguyen, Uyen, Pogorzelski, David, Rojas, Alejandra, Scott, Taryn, Del Fabbro, Gina, Szasz, Olivia Paige, McKay, Paula, Howe, Andrea, Rudnicki, Joshua, Demyanovich, Haley, Little, Kelly, Mullins, C. Daniel, Medeiros, Michelle, Kettering, Eric, Hale, Diamond, Eglseder, Andrew, Johnson, Aaron, Langhammer, Christopher, Lebrun, Christopher, Manson, Theodore, Nascone, Jason, Paryavi, Ebrahim, Pensy, Raymond, Pollak, Andrew, Sciadini, Marcus, Degani, Yasmin, Demyanovich, Haley K., Joseph, Katherine, Petrisor, Brad A., Johal, Herman, Ristevski, Bill, Williams, Dale, Denkers, Matthew, Rajaratnam, Krishan, Al-Asiri, Jamal, Leonard, Jordan, Marcano-Fernández, Francesc A., Gallant, Jodi, Persico, Federico, Gjorgjievski, Marko, George, Annie, Natoli, Roman M., Gaski, Greg E., McKinley, Todd O., Virkus, Walter W., Sorkin, Anthony T., Szatkowski, Jan P., Baele, Joseph R., Mullis, Brian H., Hill, Lauren C., Hudgins, Andrea, Osborn, Patrick, Pierrie, Sarah, Martinez, Eric, Kimmel, Joseph, Adams, John D., Beckish, Michael L., Bray, Christopher C., Brown, Timothy R., Cross, Andrew W., Dew, Timothy, Faucher, Gregory K., Gurich, Richard W., Jr., Lazarus, David E., Millon, S. John, Palmer, M. Jason, Porter, Scott E., Schaller, Thomas M., Sridhar, Michael S., Sanders, John L., Rudisill, L. Edwin, Jr., Garitty, Michael J., Poole, Andrew S., Sims, Michael L., Walker, Clark M., Carlisle, Robert M., II, Hofer, Erin Adams, Huggins, Brandon S., Hunter, Michael D., Marshall, William A., Ray, Shea Bielby, Smith, Cory D., Altman, Kyle M., Bedard, Julia C., Loeffler, Markus F., Pichiotino, Erin R., Cole, Austin A., Maltz, Ethan J., Parker, Wesley, Ramsey, T. Bennett, Burnikel, Alex, Colello, Michael, Stewart, Russell, Wise, Jeremy, Moody, M. Christian, Tanner, Stephanie L., Snider, Rebecca G., Townsend, Christine E., Pham, Kayla H., Martin, Abigail, Robertson, Emily, Miclau, Theodore, Kandemir, Utku, Marmor, Meir, Matityahu, Amir, McClellan, R. Trigg, Meinberg, Eric, Shearer, David, Toogood, Paul, Ding, Anthony, Donohue, Erin, Belaye, Tigist, Berhaneselase, Eleni, Paul, Alexandra, Garg, Kartik, Gary, Joshua L., Warner, Stephen J., Munz, John W., Choo, Andrew M., Achor, Timothy S., “Chip” Routt, Milton L., Rao, Mayank, Pechero, Guillermo, Miller, Adam, Hagen, Jennifer E., Patrick, Matthew, Vlasak, Richard, Krupko, Thomas, Sadasivan, Kalia, Koenig, Chris, Bailey, Daniel, Wentworth, Daniel, Van, Chi, Schwartz, Justin, Dehghan, Niloofar, Jones, Clifford B., Watson, J Tracy, McKee, Michael, Karim, Ammar, Talerico, Michael, Sietsema, Debra L., Williams, Alyse, Dykes, Tayler, Obremskey, William T., Jahangir, Amir Alex, Sethi, Manish, Boyce, Robert, Stinner, Daniel J., Mitchell, Phillip, Trochez, Karen, Rodriguez, Andres, Gajari, Vamshi, Rodriguez, Elsa, Pritchett, Charles, Boulton, Christina, Lowe, Jason, Wild, Jason, Ruth, John T., Taylor, Michel, Seach, Andrea, Saeed, Sabina, Culbert, Hunter, Cruz, Alejandro, Knapp, Thomas, Hurkett, Colin, Lowney, Maya, Prayson, Michael, Venkatarayappa, Indresh, Horne, Brandon, Jerele, Jennifer, Clark, Linda, Marcano-Fernández, Francesc, Jornet-Gibert, Montsant, Martínez-Carreres, Laia, Martí-Garín, David, Serrano-Sanz, Jorge, Sánchez-Fernández, Joel, Sanz-Molero, Matsuyama, Carballo, Alejandro, Pelfort, Xavier, Acerboni-Flores, Francesc, Alavedra-Massana, Anna, Anglada-Torres, Neus, Berenguer, Alexandre, Cámara-Cabrera, Jaume, Caparros-García, Ariadna, Fillat-Gomà, Ferran, Fuentes-López, Ruben, Garcia-Rodriguez, Ramona, Gimeno-Calavia, Nuria, Graells-Alonso, Guillem, Martínez-Álvarez, Marta, Martínez-Grau, Patricia, Pellejero-García, Raúl, Ràfols-Perramon, Ona, Peñalver, Juan Manuel, Domènech, Mònica Salomó, Soler-Cano, Albert, Velasco-Barrera, Aldo, Yela-Verdú, Christian, Bueno-Ruiz, Mercedes, Sánchez-Palomino, Estrella, Guerra, Ernesto, García, Yaiza, Romeo, Nicholas M., Vallier, Heather A., Breslin, Mary A., Fraifogl, Joanne, Wilson, Eleanor S., Wadenpfuhl, Leanne K., Halliday, Paul G., Viskontas, Darius G., Apostle, Kelly L., Boyer, Dory S., Moola, Farhad O., Perey, Bertrand H., Stone, Trevor B., Lemke, H. Michael, Zomar, Mauri, Spicer, Ella, Fan, Chen “Brenda”, Payne, Kyrsten, Phelps, Kevin, Bosse, Michael, Karunakar, Madhav, Kempton, Laurence, Sims, Stephen, Hsu, Joseph, Seymour, Rachel, Churchill, Christine, Bartel, Claire, Mayberry, Robert Miles, Brownrigg, Maggie, Girardi, Cara, Mayfield, Ada, Hymes, Robert A., Schwartzbach, Cary C., Schulman, Jeff E., Malekzadeh, A. Stephen, Holzman, Michael A., Ramsey, Lolita, Ahn, James S., Panjshiri, Farhanaz, Das, Sharmistha, English, Antoinisha D., Haaser, Sharon M., Cuff, Jaslynn A.N., Pilson, Holly, Carroll, Eben A., Halvorson, Jason J., Babcock, Sharon, Goodman, J. Brett, Holden, Martha B., Bullard, Debra, Williams, Wendy, Higgins, Thomas F., Haller, Justin M., Rothberg, David L., Neese, Ashley, Russell, Mark, Coe, Marcus, Dwyer, Kevin, Mullin, Devin S., Reilly, Clifford A., DePalo, Peter, Hall, Amy E., Heng, Marilyn, Harris, Mitchel B., Smith, R. Malcolm, Lhowe, David W., Esposito, John G., Bansal, Mira, Bergin, Patrick F., Russell, George V., Graves, Matthew L., Morellato, John, Champion, Heather K., Johnson, Leslie N., McGee, Sheketha L., Bhanat, Eldrin L., Mehta, Samir, Donegan, Derek, Ahn, Jaimo, Horan, Annamarie, Dooley, Mary, Kuczinski, Ashley, Iwu, Ashley, Potter, David, VanDemark, Robert, III, Pfaff, Branden, Hollinsworth, Troy, Weaver, Michael J., von Keudell, Arvind G., McTague, Michael F., Allen, Elizabeth M., Jaeblon, Todd, Beer, Robert, Gage, Mark J., Reilly, Rachel M., Sparrow, Cindy, and McGee, Sheketha

Published
2021
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38. Delays in hospital admissions in patients with fractures across 18 low-income and middle-income countries (INORMUS): a prospective observational study

Author

Bhandari, Mohit, Devereaux, PJ, Guyatt, Gordon, Petrisor, Brad, Thabane, Lehana, Boniface, Respicious L., Browner, Bruce, de la Huerta, Fernando, Ivers, Rebecca Q, Miclau, Theodore, III, Moroz, Paul, Pollak, Andrew, Slobogean, Gerard, Sancheti, Parag, Schemitsch, Emil, Zhou, Junlin, Sprague, Sheila, McKay, Paula, Li, Chuan Silvia, Mundi, Raman, O'Hara, Nathan, Heels-Ansdell, Diane, Buckingham, Lisa, Simunovic, Nicole, Jagnoor, Jagnoor, Norton, Robyn, Zhang, Jing, Tian, Maoyi, Bhaumik, Soumyadeep, Parveen, Samina, Morshed, Saam, MacKechnie, Madeline C., Liu, Yang, Zhao, Yanrui, Li, Junfei, Zhang, Haoran, Zhang, Zhentao, Zhang, Wei, Guo, Tao, Chen, Guang, Jia, Zichao, Yang, Jianzhong, Kang, Lixing, Zhang, Peng, Ma, Haoqing, Liu, Donghai, Ma, Yinghua, Qin, Yanguo, Wang, Jincheng, Liu, He, Ma, Xinlong, Ma, Jianxiong, Jia, Haobo, Cui, Shuangshuang, Zhao, Zhihu, Fu, Lin, Jiang, Hongqiang, Lv, Jianwei, Hu, Sanbao, Wang, Yongwei, Sun, Mingyao, Tao, Shuqing, Qi, Baochang, Gao, Ming, Wu, Bo, Zhi, Chunsheng, Xing, Ben, Yang, Jun, Dai, Wenjie, Lu, Duo, He, Shisheng, Cai, Xinyu, Liu, Gejun, Rui, Gang, Hu, Baoshan, Shi, Pingfang, Chen, Hua, Wang, Te, Wang, Qingqing, Xie, Linzhen, Xie, Huanguang, Mutanda, Tony, Ntuulo, Juliet, Lubega, Flavia, Tracy, Gayita Teddy, Zaitun, Kayondo, Ndayisaba, Sylvester, Amone, Titus, Odong, Samuel Remmy, Lutomia, Mark, Okatch, Caesar, Bitok, Thomas, Kiambuthi, Alexander, Otsyeno, Fred Mathew Toboso, Jani, Pankaj G, Mutiso, Vincent Muoki, Ating'a, John EO, Kilonzo, Peter Kavoo, Muoki, James, Mbogori, Makena, Wambugu, Joan Wambui, Torutt, Dorothy, Odok, Christopher, Ngetich, Elisha, Otsyeno, Dean, Wakhayanga, Juma, Nzioka, Desmond, Owende, Deogracia, Lucinde, Ruth, Kariuki, Brian Ngure, Kinyua, Dennis, Kamau, Maureen, Mwancha, Maureen, Murgor, Mellany, Nyabuti, Marilyn, Njoki, Rita, Wanza, Patricia, Odongo, Abraham, Marealle, Paul, Wanini, Athman, Elisha, Marwa, Zumbulu, Damas, Godfrey, Pariyo Bonane, Ndeleva, Benjamin Mukulu, Johnson, Murila, Kimani, Moses, Gichui, Kinuthia, Temu, Rogers Joachin, Mselle, Angela Neofitus, Kimario, Ancelimu Rafael, Ramokgopa, Mmampapatla Thomas, Firth, Gregory, Biscardi, Anna Grisillo, Poopedi, Machuene Ananias, Moolman, Johan, Milner, Brenda, Maluleke, Matimba, Jingo, Maxwell, van Deventer, Susan, Pikor, Timothy, Bhaga, Ravi, Mara, Michael, Mwangi, Geoffrey Chege, Maina, Anthony Muchiri, Gicheru, David Wamae, Mwangi, Carol, Wangai, Isaac Kingori, Maina, Peter Watson, Kiptoo, Ezra Mitei, Temiloluwa, Olufemi Olukemi, Ikechukwu, Adeyeye Adeolu, Olugbenga, Ige Oluwole, Bamidele, Ojodu Ishaq, Akanbi, Oladimeji Oladipupo, Subramanian, Panchu, Mosweu, Olivia L, Hailu, Samuel, Tessema, Geletaw, Bezabih, Bahiru, Ayana, Birhanu, Hailu, Hiwot, Zewdneh, Betelhem, Tesfaye, Hana, Tadesse, Sosena, Konadu-Yeboah, Dominic, Ativor, Vincent, Konadu, Peter, Awariyah, Dominic, Quartey, Raphael, Kumah-Ametepey, Raphael, Saani, Osman, Quansah, Robert Ekow, Baidoo, Paa Kwesi, Trafton, Peter, Anyitey-Korkor, David, Leat, Michael, Sobotie, Johnny, Opuni, Godwin, Kusi, Kwasi, Baah, Twimasi, Okyere, Paul, Mensah, Bernice, Sarpong, Doris Akuoko, Agbenorwu, Felicia, Osei-Donkor, Phyllis, Opoku, Priscilla, Segbefia, Michael, Oguzie, Gerald Chukwuemeka, Iyidobi, Emmanuel Chino, Nwadinigwe, Cajetan Uwatoronye, Oguzie, Sharon Amarachi Uloma, Kesiena, Emina Bami, Ndasi, Henry Tanyi, Ghislain, Nietiayurk Aminake, Shey, Mala Irine, Nanje, Ikose John, Shyam, Ashok, Borate, Madhav, Patil, Sampat Dumbre, Karkamakar, Sachin, Patil, Shailesh, Ranaware, Abhijeet, Tamboli, Shadab, Gandhalikar, Manish, Tupe, Rohini, Chaudhari, Vishal, Joshi, Avanti, Patil, Sanjay, Dalwekar, Mohit Madhukar, Gandhi, Tejas, Latkar, Chintamani, Pundkare, Gopal, Shrivastava, Sandeep, Singh, Pradeep K, Deshpande, Sanjay, Baheti, Sumit, Mittal, Ravi, Sharma, Vijay, Cherian, Vinoo Mathew, Jepegnanam, Thilak Samuel, Titus, Vijay T K, Nithyananth, Manasseh, Boopalan, Palapattu R J V C, Varghese, Viju Daniel, Arockiaraj, Justin, Mahajan, Anupam, John, Bobby, Pandey, Ritesh, Prakash, Jeewan S, Abraham, Valsamma, Rajkumar, Arti, Chhabra, Harvinder Singh, Sharawat, Rajesh, Kumar, Ritabh, Chawla, Pushkar, Yadav, Rashmi, Iyer, Rajagopalan N, Nair, Naveen, Amaravathi, Rajkumar S, Santhanagopa, Srinivasalu, Pilar, Anoop, Tamboowala, Keith Behram, Dhillon, Mandeep S, Dhatt, Sarvdeep S, Chase, Asolie, Bhavsar, Neel M, Musa, Rameez, Shah, Darshan, Chodavadiyah, Sunil, Patel, Pankaj G, Qadir, Raja Irfan, Bukhari, Syed Imran, Baz, Khushnood Ali, Byanjankar, Subin, Joshi, Ruban Raj, Dwivedi, Rajeev, Sharma, Jay Raj, Quang, La Ngoc, Chinh, Nguyen Duc, Hong, Vu Bao, Sa-ngasoongsong, Paphon, Kulachote, Noratep, Sirisreetreerux, Norachart, Pongsamakthai, Wanjak, Tabu, Irewin Alagar, Reyes, Paula Veronica, Caiquep, Iardinne, Bituin, Joni Mitchell Robles, González, Jenna, Golbakhsh, Mohammadreza, Haddadi, Mashyaneh, Saadat, Soheil, Zafarghandi, Mohammadreza, Orozco, Clotilde Fuentes, Ruíz, José de Jesús Martínez, Arreguin, Gustavo Armando Tafoya, Flores, César Eduardo Pinedo, Verduzco, Irydia Guadalupe Pellegrini, Camacho, Miguel Oscar Hernandez, Téllez, Diego Abraham Estrada, López, Rodrigo Salcedo, Navarro, Ileana Guadalupe Canales, Pérez, Mizael Dennis, Carrillo, Daniel de Jesús Enciso, López, Paola Alejandra Álvarez, Gómez, Adán Cervantes, Bravo, Fátima Nohemí Franco, Arias, Eugenia de los Ángeles Reyes, Elguezabal, Igor A. Escalante, Rizzo, Ennio Antonio, Hovsepian, Jean Michel, Rodriguez, Victor, Baldo, Manuel Malaret, Serrano, Andres, Valenciano, Carlos G. Sanchez, Salcedo, Edgar Efren Mercado, Medina, Fryda, Bidolegui, Fernando, Pereira, Sebastian, Aguilar, Gerardo, Rubio-Avila, Jorge, Belangero, William Dias, Mariolani, José Ricardo Lenzi, Livani, Bruno, Lugnani, André, Rossi, Felipe, Katayama, Angela, Baldy, Fernando, de Moraes, Vinícius Ynoe, Fogagnolo, Fabricio, Kojima, Kodi Edson, Silva, Jorge dos Santos, Demange, Marco Kawamura, de Andrade-Silva, Fernando Brandão, da Silva, Adriana Carvalho Gomes, Elias, Nelson, Martinez, Dino Aguilar, Contreras, Fernando, Garuz, Mario, Quintero, Jose Eduardo, Merchan, Gavino, Lurita, Christian M. Lozano, Manrique, Aturo D. Torres, Fernandez, Jorge Hurtado, Vincenti, Sergio Iriarte, Bobarin, Alfredo Pozzo, Sanchez, Dalton Salinas, Altieri, Julio Segovia, Almada, Diego, Bogado, Derlis, Coronel, Carlos, Boveda, Cristian, del Valle, Victor, Montiel, Carlos, Marin, Nelson, Barquet, Antonio, Rienzi, Daniel, Amanquez, Carlos, Beauvoir, Georges, Cutipa, Iván J Salce, Ribeiro, José Eduardo Grandi, Avila, José María Jiménez, Padilla, Luis, Ochoa, Hernando Cuevas, Cano, Hernando Cuevas, González, Adriana Vaca, Gutierrez, Nubia Itzel Gonzalez, Espinola, Victor, Pouramin, Panthea, Busse, Jason W, Devereaux, P J, and Ivers, Rebecca

Published
2020
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39. REVISE:Re-Evaluating theInhibition ofStressErosions in the ICU: a randomised trial protocol

Author

Deane, Adam M, primary, Alhazzani, Waleed, additional, Guyatt, Gordon, additional, Finfer, Simon, additional, Marshall, John C, additional, Myburgh, John, additional, Zytaruk, Nicole, additional, Hardie, Miranda, additional, Saunders, Lois, additional, Knowles, Serena, additional, Lauzier, Francois, additional, Chapman, Marianne J, additional, English, Shane, additional, Muscedere, John, additional, Arabi, Yaseen, additional, Ostermann, Marlies, additional, Venkatesh, Balasubramanian, additional, Young, Paul, additional, Thabane, Lehana, additional, Billot, Laurent, additional, Heels-Ansdell, Diane, additional, Al-Fares, Abdulrahman A, additional, Hammond, Naomi E, additional, Hall, R, additional, Rajbhandari, Dorrilyn, additional, Poole, Alexis, additional, Johnson, Daniel, additional, Iqbal, Mobeen, additional, Reis, Gilmar, additional, Xie, Feng, additional, and Cook, Deborah J, additional

Published
2023
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41. Preoperative levels of natriuretic peptides and the incidence of postoperative atrial fibrillation after noncardiac surgery: a prospective cohort study

Author

Szczeklik, Wojciech, LeManach, Yannick, Fronczek, Jakub, Polok, Kamil, Conen, David, McAlister, Finlay A., Srinathan, Sadeesh, Alonso-Coello, Pablo, Biccard, Bruce, Duceppe, Emmanuelle, Heels-Ansdell, Diane, Gorka, Jacek, Pettit, Shirley, Roshanov, Pavel S., and Devereaux, P.J.

Subjects
Atrial fibrillation -- Risk factors, Postoperative complications -- Risk factors, Natriuretic peptides -- Health aspects, Health
Abstract

BACKGROUND: Postoperative atrial fibrillation (POAF) is associated with clinically significant short- and long-term complications after noncardiac surgery. Our aim was to describe the incidence of clinically important POAF after noncardiac surgery and establish the prognostic value of N-terminal pro-brain-type natriuretic peptide (NT-proBNP) in this context. METHODS: The Vascular events In noncardiac Surgery patients cOhort evaluatioN (VISION) Study was a prospective cohort study involving patients aged 45 years and older who had inpatient noncardiac surgery that was performed between August 2007 and November 2013. We determined 30-day incidence of clinically important POAF (i.e., resulting in angina, congestive heart failure, symptomatic hypotension or requiring treatment) using logistic regression models to analyze the association between preoperative NT-proBNP and POAF. RESULTS: In 37664 patients with no history of atrial fibrillation, we found that the incidence of POAF was 1.0% (95% confidence interval [CI] 0.9%-1.1%; 369 events); 3.2% (95% CI 2.3%-4.4%) in patients undergoing major thoracic surgery, 1.3% (95% CI 1.2%-1.5%) in patients undergoing major nonthoracic surgery and 0.2% (95% CI 0.1%0.3%) in patients undergoing low-risk surgery. In a subgroup of 9789 patients with preoperative NT-proBNP measurements, the biomarker improved the prediction of POAF risk over conventional prognostic factors (likelihood ratio test p < 0.001; fraction of new information from NT-proBNP was 16%). Compared with a reference NT-proBNP measurement set at 100 ng/L, adjusted odds ratios for the occurrence of POAF were 1.31 (95% CI 1.15-1.49) at 200 ng/L, 2.07 (95% CI 1.27-3.36) at 1500 ng/L and 2.39 (95% CI 1.26-4.51) at 3000 ng/L. INTERPRETATION: We determined that the incidence of clinically important POAF after noncardiac surgery was 1.0%. We also found that preoperative NT-proBNP levels were associated with POAF independent of established prognostic factors. Trial registration: ClinicalTrials.gov, no. NCT00512109, Postoperative atrial fibrillation (POAF) is the most common arrhythmia that occurs after noncardiac surgery (1) and is associated with prolonged hospital stays and an increased risk of stroke and death, [...]

Published
2020
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42. One-year Outcomes after Discharge from Noncardiac Surgery and Association between Predischarge Complications and Death after Discharge: Analysis of the VISION Prospective Cohort Study

Author

Roshanov, Pavel S., primary, Chan, Matthew T. V., additional, Borges, Flavia K., additional, Conen, David, additional, Wang, C. Y., additional, Xavier, Denis, additional, Berwanger, Otavio, additional, Marcucci, Maura, additional, Sessler, Daniel I., additional, Szczeklik, Wojciech, additional, Spence, Jessica, additional, Alonso-Coello, Pablo, additional, Fernández, Carmen, additional, Pearse, Rupert M., additional, Malaga, German, additional, Garg, Amit X., additional, Srinathan, Sadeesh K., additional, Jacka, Michael J., additional, Tandon, Vikas, additional, McGillion, Michael, additional, Popova, Ekaterine, additional, Sigamani, Alben, additional, Abraham, Valsa, additional, Biccard, Bruce M., additional, Villar, Juan Carlos, additional, Chow, Clara K., additional, Polanczyk, Carísi A., additional, Tiboni, Maria, additional, Whitlock, Richard, additional, Ackland, Gareth L., additional, Panju, Mohamed, additional, Lamy, André, additional, Sapsford, Robert, additional, Williams, Colin, additional, Wu, William Ka Kei, additional, Cortés, Olga L., additional, MacNeil, S. Danielle, additional, Patel, Ameen, additional, Belley-Côté, Emilie P., additional, Ofori, Sandra, additional, McIntyre, William F., additional, Leong, Darryl P., additional, Heels-Ansdell, Diane, additional, Gregus, Krysten, additional, and Devereaux, P. J., additional

Published
2023
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43. Association Between Myocardial Injury and Cardiovascular Outcomes of Orthopaedic Surgery: A Vascular Events in Noncardiac Surgery Patients Cohort Evaluation (VISION) Substudy

Author

Thomas, Sabu, Borges, Flavia, Bhandari, Mohit, De Beer, Justin, Urrútia Cuchí, Gerard, Adili, Anthony, Winemaker, Mitchell, Avram, Victoria, Chan, Matthew T.V., Lamas, Claudia, Cruz, Patricia, Aguilera, Xavier, Garutti, Ignacio, Alonso-Coello, Pablo, Villar, Juan Carlos, Jacka, Michael, Wang, C.Y., Berwanger, Otavio, Chow, Clara, Srinathan, Sadeesh, Pettit, Shirley, Heels-Ansdell, Dianne, Rubery, Paul, Devereaux, P.J., Thomas, Sabu, Walsh, Michael, Tiboni, Maria, Guyatt, Gordon, Heels-Ansdell, Diane, Thorlund, Kristian, Thabane, Lehana, Bhandari, Mohit, Bosch, Jackie, Chan, Matthew T.V., Shatin, NT, Alonso-Coello, Pablo, Berwanger, Otavio, Carlos Villar, Juan, Wang, C.Y., Garutti, R. Ignacio, Jacka, Michael J., Sigamani, Alben, Srinathan, Sadeesh, Biccard, Bruce M., Rodseth, Reitze N., Chow, Clara K., Abraham, Valsa, Pettit, Shirley, McQueen, Matthew J., VanHelder, Tomas, Szczeklik, Wojciech, Buse, Giovanna Lurati, Botto, Fernando, Yusuf, Salim, Sessler, Daniel I., Kurz, Andrea, Garg, Amit X., Mrkobrada, Marko, Pearse, Rupert M., Polanczyk, Carisi A., Malaga, German, Nagele, Peter, Le Manach, Yannick, Leuwer, Martin, and Devereaux, P.J.

Published
2020
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44. (Sample) Size Matters! An Examination of Sample Size From the SPRINT Trial Study to Prospectively Evaluate Reamed Intramedullary Nails in Patients With Tibial Fractures

Author

Bhandari, Mohit, Tornetta, Paul, Rampersad, Shelly-Ann, Sprague, Sheila, Heels-Ansdell, Diane, Sanders, David W, Schemitsch, Emil H, Swiontkowski, Marc, and Walter, Stephen

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Clinical Research, Clinical Trials and Supportive Activities, Adult, Bone Nails, Female, Fracture Fixation, Intramedullary, Fractures, Closed, Fractures, Open, Humans, Male, Middle Aged, Sample Size, Tibial Fractures, Young Adult, intramedullary nailing, sample size, tibia fracture, SPRINT Investigators, Orthopedics, Clinical sciences
Abstract

IntroductionInadequate sample size and power in randomized trials can result in misleading findings. This study demonstrates the effect of sample size in a large clinical trial by evaluating the results of the Study to Prospectively evaluate Reamed Intramedullary Nails in Patients with Tibial fractures (SPRINT) trial as it progressed.MethodsThe SPRINT trial evaluated reamed versus unreamed nailing of the tibia in 1226 patients, and in open and closed fracture subgroups (N = 400 and N = 826, respectively). We analyzed the reoperation rates and relative risk comparing treatment groups at 50, 100, and then increments of 100 patients up to the final sample size. Results at various enrollments were compared with the final SPRINT findings.ResultsIn the final analysis, there was a statistically significant decreased risk of reoperation with reamed nails for closed fractures (relative risk reduction 35%). Results for the first 35 patients enrolled suggested that reamed nails increased the risk of reoperation in closed fractures by 165%. Only after 543 patients with closed fractures were enrolled did the results reflect the final advantage for reamed nails in this subgroup. Similarly, the trend toward an increased risk of reoperation for open fractures (23%) was not seen until 62 patients with open fractures were enrolled.ConclusionsOur findings highlight the risk of conducting a trial with insufficient sample size and power. Such studies are not only at risk of missing true effects but also of giving misleading results.

Published
2013

46. Critical Care Cycling to ImproveLowerExtremity Strength (CYCLE): protocol for an international, multicentre randomised clinical trial of early in-bed cycling for mechanically ventilated patients

Author

Kho, Michelle E, primary, Reid, Julie, additional, Molloy, Alexander J, additional, Herridge, Margaret S, additional, Seely, Andrew J, additional, Rudkowski, Jill C, additional, Buckingham, Lisa, additional, Heels-Ansdell, Diane, additional, Karachi, Tim, additional, Fox-Robichaud, Alison, additional, Ball, Ian M, additional, Burns, Karen E A, additional, Pellizzari, Joseph R, additional, Farley, Christopher, additional, Berney, Sue, additional, Pastva, Amy M, additional, Rochwerg, Bram, additional, D'Aragon, Frédérick, additional, Lamontagne, Francois, additional, Duan, Erick H, additional, Tsang, Jennifer L Y, additional, Archambault, Patrick, additional, English, Shane W, additional, Muscedere, John, additional, Serri, Karim, additional, Tarride, Jean-Eric, additional, Mehta, Sangeeta, additional, Verceles, Avelino C, additional, Reeve, Brenda, additional, O'Grady, Heather, additional, Kelly, Laurel, additional, Strong, Geoff, additional, Hurd, Abby H, additional, Thabane, Lehana, additional, and Cook, Deborah J, additional

Published
2023
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