21 results on '"Greg E. Gaski"'
Search Results
2. Patient-Specific Precision Injury Signatures to Optimize Orthopaedic Interventions in Multiply Injured Patients (PRECISE STUDY)
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Todd O. McKinley, Greg E. Gaski, Timothy R. Billiar, Yoram Vodovotz, Krista M. Brown, Eric A. Elster, Greg M. Constantine, Seth A. Schobel, Henry T. Robertson, Ashley D. Meagher, Reza Firoozabadi, Joshua L. Gary, Robert V. O'Toole, Arun Aneja, Karen M. Trochez, Laurence B. Kempton, Scott D. Steenburg, Susan C. Collins, Katherine P. Frey, and Renan C. Castillo
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Orthopedics and Sports Medicine ,Surgery ,General Medicine - Published
- 2022
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3. Predictors of Improved Early Clinical Outcomes After Elective Implant Removal
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Krista M. Brown, Laurence B. Kempton, Todd O. McKinley, Walter W Virkus, and Greg E. Gaski
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Patient-Reported Outcomes Measurement Information System ,medicine.medical_specialty ,Visual analogue scale ,Population ,03 medical and health sciences ,0302 clinical medicine ,Humans ,Medicine ,Orthopedics and Sports Medicine ,Patient Reported Outcome Measures ,Prospective Studies ,Prospective cohort study ,education ,Device Removal ,Pain Measurement ,030222 orthopedics ,education.field_of_study ,business.industry ,Trauma center ,030208 emergency & critical care medicine ,General Medicine ,Evidence-based medicine ,Elective Surgical Procedures ,Physical therapy ,Surgery ,Implant ,business ,Elective Surgical Procedure - Abstract
OBJECTIVES To determine preoperative factors predictive of improvement in pain and function after elective implant removal. We hypothesized that patients undergoing orthopaedic implant removal to relieve pain would have significant improvements in both pain and function. DESIGN Prospective cohort study. SETTING Level I Trauma Center. PATIENTS/PARTICIPANTS One hundred eighty-nine patients were enrolled after consenting for orthopaedic implant removal to address residual pain. One hundred sixty-three were available for 3-month follow-up. MAIN OUTCOME MEASUREMENT Preoperative and postoperative outcome measures including Patient Reported Outcomes Measurement Information System (PROMIS) scores were compared. Preoperative scores, surgeon prediction of pain improvement, and palpable implants were analyzed as predictors of outcomes. RESULTS Median PROMIS physical function and pain interference scores and visual analogue scale significantly improved by 6, 8, and 2 points, respectively (P < 0.001 for all). Worse preinjury scores predicted improvement in respective postoperative outcomes (P < 0.001 for all). Surgeon prediction of improvement was associated with improved PROMIS pain interference (P = 0.005), patient subjective assessment of pain improvement (P = 0.03), and subjective percent of pain remaining at 3 months (P = 0.02). Implant superficial palpability was not predictive for any postoperative outcomes. CONCLUSIONS Although the primary indication for implant removal in this population was pain relief, many patients also had a clinically relevant improvement in physical function. In addition, patients who start with worse global indices of pain and function are more likely to improve after implant removal. This suggests that implant-related pain directly contributes to global dysfunction. LEVEL OF EVIDENCE Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.
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- 2021
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4. Aqueous skin antisepsis before surgical fixation of open fractures (Aqueous-PREP): a multiple-period, cluster-randomised, crossover trial
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Gerard P. Slobogean, Sheila Sprague, Jeffrey L. Wells, Mohit Bhandari, Anthony D. Harris, C. Daniel Mullins, Lehana Thabane, Amber Wood, Gregory J. Della Rocca, Joan N. Hebden, Kyle J. Jeray, Lucas S. Marchand, Lyndsay M. O'Hara, Robert D. Zura, Christopher Lee, Joseph T. Patterson, Michael J. Gardner, Jenna Blasman, Jonah Davies, Stephen Liang, Monica Taljaard, PJ Devereaux, Gordon Guyatt, Diane Heels-Ansdell, Debra Marvel, Jana E. Palmer, Jeff Friedrich, Nathan N. O'Hara, Frances Grissom, I. Leah Gitajn, Saam Morshed, Robert V. O'Toole, Bradley Petrisor, Franca Mossuto, Manjari G. Joshi, Jean-Claude G. D'Alleyrand, Justin Fowler, Jessica C. Rivera, Max Talbot, David Pogorzelski, Shannon Dodds, Silvia Li, Gina Del Fabbro, Olivia Paige Szasz, Sofia Bzovsky, Paula McKay, Alexandra Minea, Kevin Murphy, Andrea L. Howe, Haley K. Demyanovich, Wayne Hoskins, Michelle Medeiros, Genevieve Polk, Eric Kettering, Nirmen Mahal, Andrew Eglseder, Aaron Johnson, Christopher Langhammer, Christopher Lebrun, Jason Nascone, Raymond Pensy, Andrew Pollak, Marcus Sciadini, Yasmin Degani, Heather Phipps, Eric Hempen, Herman Johal, Bill Ristevski, Dale Williams, Matthew Denkers, Krishan Rajaratnam, Jamal Al-Asiri, Jodi L. Gallant, Kaitlyn Pusztai, Sarah MacRae, Sara Renaud, John D. Adams, Michael L. Beckish, Christopher C. Bray, Timothy R. Brown, Andrew W. Cross, Timothy Dew, Gregory K. Faucher, Richard W. Gurich Jr, David E. Lazarus, S. John Millon, M. Christian Moody, M. Jason Palmer, Scott E. Porter, Thomas M. Schaller, Michael S. Sridhar, John L. Sanders, L. Edwin Rudisill Jr, Michael J. Garitty, Andrew S. Poole, Michael L. Sims, Clark M. Walker, Robert Carlisle, Erin A. Hofer, Brandon Huggins, Michael Hunter, William Marshall, Shea B. Ray, Cory Smith, Kyle M. Altman, Erin R. Pichiotino, Julia C. Quirion, Markus F. Loeffler, Austin A. Cole, Ethan J. Maltz, Wesley Parker, T. Bennett Ramsey, Alex Burnikel, Michael Colello, Russell Stewart, Jeremy Wise, Matthew Anderson, Joshua Eskew, Benjamin Judkins, James M. Miller, Stephanie L. Tanner, Rebecca G. Snider, Christine E. Townsend, Kayla H. Pham, Abigail Martin, Emily Robertson, Emily Bray, J. Wilson Sykes, Krystina Yoder, Kelsey Conner, Harper Abbott, Roman M. Natoli, Todd O. McKinley, Walter W. Virkus, Anthony T. Sorkin, Jan P. Szatkowski, Brian H. Mullis, Yohan Jang, Luke A. Lopas, Lauren C. Hill, Courteney L. Fentz, Maricela M. Diaz, Krista Brown, Katelyn M. Garst, Emma W. Denari, Patrick Osborn, Sarah N. Pierrie, Bradley Kessler, Maria Herrera, Theodore Miclau, Meir T. Marmor, Amir Matityahu, R. Trigg McClellan, David Shearer, Paul Toogood, Anthony Ding, Jothi Murali, Ashraf El Naga, Jennifer Tangtiphaiboontana, Tigist Belaye, Eleni Berhaneselase, Dmitry Pokhvashchev, William T. Obremskey, Amir Alex Jahangir, Manish Sethi, Robert Boyce, Daniel J. Stinner, Phillip P. Mitchell, Karen Trochez, Elsa Rodriguez, Charles Pritchett, Natalie Hogan, A. Fidel Moreno, Jennifer E. Hagen, Matthew Patrick, Richard Vlasak, Thomas Krupko, Michael Talerico, Marybeth Horodyski, Marissa Pazik, Elizabeth Lossada-Soto, Joshua L. Gary, Stephen J. Warner, John W. Munz, Andrew M. Choo, Timothy S. Achor, Milton L. 'Chip' Routt, Michael Kutzler, Sterling Boutte, Ryan J. Warth, Michael J. Prayson, Indresh Venkatarayappa, Brandon Horne, Jennifer Jerele, Linda Clark, Christina Boulton, Jason Lowe, John T. Ruth, Brad Askam, Andrea Seach, Alejandro Cruz, Breanna Featherston, Robin Carlson, Iliana Romero, Isaac Zarif, Niloofar Dehghan, Michael McKee, Clifford B. Jones, Debra L. Sietsema, Alyse Williams, Tayler Dykes, Ernesto Guerra-Farfan, Jordi Tomas-Hernandez, Jordi Teixidor-Serra, Vicente Molero-Garcia, Jordi Selga-Marsa, Juan Antonio Porcel-Vazquez, Jose Vicente Andres-Peiro, Ignacio Esteban-Feliu, Nuria Vidal-Tarrason, Jordi Serracanta, Jorge Nuñez-Camarena, Maria del Mar Villar-Casares, Jaume Mestre-Torres, Pilar Lalueza-Broto, Felipe Moreira-Borim, Yaiza Garcia-Sanchez, Francesc Marcano-Fernández, Laia Martínez-Carreres, David Martí-Garín, Jorge Serrano-Sanz, Joel Sánchez-Fernández, Matsuyama Sanz-Molero, Alejandro Carballo, Xavier Pelfort, Francesc Acerboni-Flores, Anna Alavedra-Massana, Neus Anglada-Torres, Alexandre Berenguer, Jaume Cámara-Cabrera, Ariadna Caparros-García, Ferran Fillat-Gomà, Ruben Fuentes-López, Ramona Garcia-Rodriguez, Nuria Gimeno-Calavia, Marta Martínez-Álvarez, Patricia Martínez-Grau, Raúl Pellejero-García, Ona Ràfols-Perramon, Juan Manuel Peñalver, Mònica Salomó Domènech, Albert Soler-Cano, Aldo Velasco-Barrera, Christian Yela-Verdú, Mercedes Bueno-Ruiz, Estrella Sánchez-Palomino, Vito Andriola, Matilde Molina-Corbacho, Yeray Maldonado-Sotoca, Alfons Gasset-Teixidor, Jorge Blasco-Moreu, Núria Fernández-Poch, Josep Rodoreda-Puigdemasa, Arnau Verdaguer-Figuerola, Heber Enrique Cueva-Sevieri, Santiago Garcia-Gimenez, Darius G. Viskontas, Kelly L. Apostle, Dory S. Boyer, Farhad O. Moola, Bertrand H. Perey, Trevor B. Stone, H. Michael Lemke, Ella Spicer, Kyrsten Payne, Robert A. Hymes, Cary C. Schwartzbach, Jeff E. Schulman, A. Stephen Malekzadeh, Michael A. Holzman, Greg E. Gaski, Jonathan Wills, Holly Pilson, Eben A. Carroll, Jason J. Halvorson, Sharon Babcock, J. Brett Goodman, Martha B. Holden, Wendy Williams, Taylor Hill, Ariel Brotherton, Nicholas M. Romeo, Heather A. Vallier, Anna Vergon, Thomas F. Higgins, Justin M. Haller, David L. Rothberg, Zachary M. Olsen, Abby V. McGowan, Sophia Hill, Morgan K. Dauk, Patrick F. Bergin, George V. Russell, Matthew L. Graves, John Morellato, Sheketha L. McGee, Eldrin L. Bhanat, Ugur Yener, Rajinder Khanna, Priyanka Nehete, David Potter, Robert VanDemark III, Kyle Seabold, Nicholas Staudenmier, Marcus Coe, Kevin Dwyer, Devin S. Mullin, Theresa A. Chockbengboun, Peter A. DePalo Sr., Kevin Phelps, Michael Bosse, Madhav Karunakar, Laurence Kempton, Stephen Sims, Joseph Hsu, Rachel Seymour, Christine Churchill, Ada Mayfield, Juliette Sweeney, Todd Jaeblon, Robert Beer, Brent Bauer, Sean Meredith, Sneh Talwar, Christopher M. Domes, Mark J. Gage, Rachel M. Reilly, Ariana Paniagua, JaNell Dupree, Michael J. Weaver, Arvind G. von Keudell, Abigail E. Sagona, Samir Mehta, Derek Donegan, Annamarie Horan, Mary Dooley, Marilyn Heng, Mitchel B. Harris, David W. Lhowe, John G. Esposito, Ahmad Alnasser, Steven F. Shannon, Alesha N. Scott, Bobbi Clinch, Becky Weber, Michael J. Beltran, Michael T. Archdeacon, Henry Claude Sagi, John D. Wyrick, Theodore Toan Le, Richard T. Laughlin, Cameron G. Thomson, Kimberly Hasselfeld, Carol A. Lin, Mark S. Vrahas, Charles N. Moon, Milton T. Little, Geoffrey S. Marecek, Denice M. Dubuclet, John A. Scolaro, James R. Learned, Philip K. Lim, Susan Demas, Arya Amirhekmat, and Yan Marco Dela Cruz
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Adult ,Male ,Canada ,Cross-Over Studies ,Chlorhexidine ,General Medicine ,Antisepsis ,Middle Aged ,Fractures, Open ,Anti-Infective Agents, Local ,Humans ,Surgical Wound Infection ,Female ,Povidone-Iodine - Abstract
Chlorhexidine skin antisepsis is frequently recommended for most surgical procedures; however, it is unclear if these recommendations should apply to surgery involving traumatic contaminated wounds where povidone-iodine has previously been preferred. We aimed to compare the effect of aqueous 10% povidone-iodine versus aqueous 4% chlorhexidine gluconate on the risk of surgical site infection in patients who required surgery for an open fracture.We conducted a multiple-period, cluster-randomised, crossover trial (Aqueous-PREP) at 14 hospitals in Canada, Spain, and the USA. Eligible patients were adults aged 18 years or older with an open extremity fracture treated with a surgical fixation implant. For inclusion, the open fracture required formal surgical debridement within 72 h of the injury. Participating sites were randomly assigned (1:1) to use either aqueous 10% povidone-iodine or aqueous 4% chlorhexidine gluconate immediately before surgical incision; sites then alternated between the study interventions every 2 months. Participants, health-care providers, and study personnel were aware of the treatment assignment due to the colour of the solutions. The outcome adjudicators and data analysts were masked to treatment allocation. The primary outcome was surgical site infection, guided by the 2017 US Centers for Disease Control and Prevention National Healthcare Safety Network reporting criteria, which included superficial incisional infection within 30 days or deep incisional or organ space infection within 90 days of surgery. The primary analyses followed the intention-to-treat principle and included all participants in the groups to which they were randomly assigned. This study is registered with ClinicalTrials.gov, NCT03385304.Between April 8, 2018, and June 8, 2021, 3619 patients were assessed for eligibility and 1683 were enrolled and randomly assigned to povidone-iodine (n=847) or chlorhexidine gluconate (n=836). The trial's adjudication committee determined that 45 participants were ineligible, leaving 1638 participants in the primary analysis, with 828 in the povidone-iodine group and 810 in the chlorhexidine gluconate group (mean age 44·9 years [SD 18·0]; 629 [38%] were female and 1009 [62%] were male). Among 1571 participants in whom the primary outcome was known, a surgical site infection occurred in 59 (7%) of 787 participants in the povidone-iodine group and 58 (7%) of 784 in the chlorhexidine gluconate group (odds ratio 1·11, 95% CI 0·74 to 1·65; p=0·61; risk difference 0·6%, 95% CI -1·4 to 3·4).For patients who require surgical fixation of an open fracture, either aqueous 10% povidone-iodine or aqueous 4% chlorhexidine gluconate can be selected for skin antisepsis on the basis of solution availability, patient contraindications, or product cost. These findings might also have implications for antisepsis of other traumatic wounds.US Department of Defense, Canadian Institutes of Health Research, McMaster University Surgical Associates, PSI Foundation.
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- 2022
5. Is Immediate Weight-Bearing Safe After Single Implant Fixation of Elderly Distal Femur Fractures?
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Charles M Lieder, Greg E. Gaski, Laurence B. Kempton, and Walter W Virkus
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medicine.medical_specialty ,Nonunion ,Periprosthetic ,law.invention ,Weight-Bearing ,Intramedullary rod ,Fracture Fixation, Internal ,03 medical and health sciences ,0302 clinical medicine ,law ,Humans ,Medicine ,Orthopedics and Sports Medicine ,Femur ,Malunion ,Aged ,Retrospective Studies ,Fixation (histology) ,Fracture Healing ,030222 orthopedics ,business.industry ,Trauma center ,030208 emergency & critical care medicine ,Retrospective cohort study ,General Medicine ,medicine.disease ,Fracture Fixation, Intramedullary ,Surgery ,Treatment Outcome ,Implant ,business ,Bone Plates ,Femoral Fractures - Abstract
Objectives To compare early complications in elderly patients with extra-articular distal femur fractures (DFFs) allowed to weight-bear as tolerated (WBAT) immediately versus patients prescribed initial touchdown weight-bearing (TDWB). Design Retrospective cohort study. Setting Level 1 academic trauma center. Patients One hundred thirty-five patients 60 years or older who underwent surgical fixation of an extra-articular DFF, including the OTA/AO fracture classification of 33-A1-3, and periprosthetic fractures with a stable knee prosthesis (Lewis and Rorabeck type I or II) with at least 6 months follow-up. Intervention Immediate WBAT or TDWB after surgical fixation of an extra-articular DFF with either an intramedullary nail or locked plate. Main outcome measurements The primary outcome was a major adverse event within the first 6 months, defined as (1) early fixation failure or change in alignment leading to reoperation, (2) nonunion, or (3) deep infection. Secondary outcomes included postoperative inpatient length of stay, discharge disposition (secondary facility vs. home), malunion, mortality, and patient-reported outcomes. Results The rate of early adverse events requiring reoperation was similar between the WBAT group (6, 10.7%) and the TDWB group (15, 19.0%; P = 0.23). There was no difference between groups with respect to length of stay, discharge disposition, malunion, and patient-reported outcomes. Conclusions This study supports allowing carefully selected elderly patients, based on surgeon preference, to immediately weight-bear after operative fixation of an extra-articular DFF regardless of implant choice. Level of evidence Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.
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- 2021
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6. The impact of COVID-19 restrictions on participant enrollment in the PREPARE trial
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David, Pogorzelski, Paula, McKay, Michael J, Weaver, Todd, Jaeblon, Robert A, Hymes, Greg E, Gaski, Joanne, Fraifogl, James S, Ahn, Sofia, Bzovsky, Gerard, Slobogean, Sheila, Sprague, Gerard P, Slobogean, Jeffrey, Wells, Mohit, Bhandari, Robert V, O'Toole, Jean-Claude, D'Alleyrand, Andrew, Eglseder, Aaron, Johnson, Christopher, Langhammer, Christopher, Lebrun, Jason, Nascone, Raymond, Pensy, Andrew, Pollak, Marcus, Sciadini, Yasmin, Degani, Haley K, Demyanovich, Andrea, Howe, Nathan N, O'Hara, Heather, Phipps, and Eric, Hempen
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Pharmacology ,General Medicine - Abstract
At the initiation of the COVID-19 pandemic, restrictions forced researchers to decide whether to continue their ongoing clinical trials. The PREPARE (Pragmatic Randomized Trial Evaluating Pre-Operative Alcohol Skin Solutions in Fractured Extremities) trial is a pragmatic cluster-randomized crossover trial in patients with open and closed fractures. PREPARE was enrolling over 200 participants per month at the initiation of the pandemic. We aim to describe how the COVID-19 research restrictions affected participant enrollment.The PREPARE protocol permitted telephone consent, however, sites were obtaining consent in-person. To continue enrollment after the initiation of the restrictions participating sites obtained ethics approval for telephone consent scripts and the waiver of a signature on the consent form. We recorded the number of sites that switched to telephone consent, paused enrollment, and the length of the pause. We used t-tests to compare the differences in monthly enrollment between July 2019 and November 2020.All 19 sites quickly implement telephone consent. Fourteen out of nineteen (73.6%) sites paused enrollment due to COVID-19 restrictions. The median length of enrollment pause was 46.5 days (range, 7-121 days; interquartile range, 61 days). The months immediately following the implementation of restrictions had significantly lower enrollment.A pragmatic design allowed sites to quickly adapt their procedures for obtaining informed consent via telephone and allowed for minimal interruptions to enrollment during the pandemic.
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- 2022
7. A Prospective Clinical Trial Comparing Surgical Fixation versus Nonoperative Management of Minimally Displaced Complete Lateral Compression Pelvis Fractures
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Roman M. Natoli, Theodore T. Manson, Nathan N O'Hara, Robert V O'Toole, Blessing Enobun, Joshua Rudnicki, Walter W Virkus, Greg E. Gaski, Todd O. McKinley, Krista M. Brown, Marcus F. Sciadini, Gerard P. Slobogean, Jeff Gill, Anthony T Sorkin, Jason W. Nascone, Andrea Howe, and Christopher T. LeBrun
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Adult ,medicine.medical_specialty ,medicine.medical_treatment ,Pelvis ,Fracture Fixation, Internal ,Fractures, Bone ,Fractures, Compression ,medicine ,Humans ,Orthopedics and Sports Medicine ,Displacement (orthopedic surgery) ,Prospective Studies ,Nonoperative management ,Brief Pain Inventory ,Reduction (orthopedic surgery) ,Fixation (histology) ,business.industry ,Bayes Theorem ,General Medicine ,Lateral compression ,Surgery ,Clinical trial ,Treatment Outcome ,medicine.anatomical_structure ,business - Abstract
OBJECTIVE To compare the early pain and functional outcomes of operative fixation versus nonoperative management for minimally displaced complete lateral compression (LC; OTA/AO 61-B1/B2) pelvic fractures. DESIGN Prospective clinical trial. SETTING Two academic trauma centers. PATIENTS Forty-eight adult patients with LC pelvic ring injuries with
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- 2021
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8. PREVENTion of CLots in Orthopaedic Trauma (PREVENT CLOT): a randomised pragmatic trial protocol comparing aspirin versus low-molecular-weight heparin for blood clot prevention in orthopaedic trauma patients
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Deborah M Stein, Gregory J Jurkovich, Elliott R Haut, Rishi Rattan, Bellal Joseph, Theodore T Manson, Yasmin Degani, Debra Marvel, Heather A Vallier, Paul S. Whiting, Robert V O'Toole, Samuel Z Goldhaber, Joseph Cuschieri, Katherine P Frey, Nathan N O'Hara, Daniel O Scharfstein, Gerard P Slobogean, Tara J Taylor, Bryce E Haac, Anthony R Carlini, Kuladeep Sudini, Stephen T Wegener, Reza Firoozabadi, Michael J Bosse, Rachel B Seymour, Martha B Holden, Ida Leah Gitajn, Alexander L Eastman, Joshua L Gary, Conor P Kleweno, Renan C Castillo, Gregory T. Altman, A Britton Christmas, Robert A. Hymes, Greg E. Gaski, Roman M. Natoli, George C. Velmahos, Michael J. Weaver, Bryan A. Cotton, Herman Johal, Niv Sne, Roman Hayda, Andrew R. Evans, Patrick M. Osborn, Jessica C. Rivera, Christina L. Boulton, Prism S. Schneider, Patrick F. Bergin, Matthew E. Kutcher, Martin A. Croce, John C. Weinlein, William Obremskey, Oscar D. Guillamondegui, Eben A. Carroll, and Preston R. Miller
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Comparative Effectiveness Research ,and promotion of well-being ,Deep vein ,METRC ,0302 clinical medicine ,Medicine ,Multicenter Studies as Topic ,030212 general & internal medicine ,Randomized Controlled Trials as Topic ,030222 orthopedics ,Aspirin ,Acetabular fracture ,Low-Molecular-Weight ,General Medicine ,Heparin ,Venous Thromboembolism ,Hematology ,Thrombosis ,Pulmonary embolism ,medicine.anatomical_structure ,Blood ,6.1 Pharmaceuticals ,Public Health and Health Services ,Patient Safety ,medicine.drug ,Adult ,medicine.medical_specialty ,medicine.drug_class ,Clinical Trials and Supportive Activities ,Clinical Sciences ,Low molecular weight heparin ,orthopaedic & trauma surgery ,03 medical and health sciences ,Clinical Research ,Humans ,3.3 Nutrition and chemoprevention ,Other Medical and Health Sciences ,business.industry ,Public health ,Prevention ,Anticoagulants ,Evaluation of treatments and therapeutic interventions ,Heparin, Low-Molecular-Weight ,thromboembolism ,medicine.disease ,Prevention of disease and conditions ,Orthopedics ,Good Health and Well Being ,Emergency medicine ,trauma management ,Injury (total) Accidents/Adverse Effects ,Surgery ,business - Abstract
Introduction Patients who sustain orthopaedic trauma are at an increased risk of venous thromboembolism (VTE), including fatal pulmonary embolism (PE). Current guidelines recommend low-molecular-weight heparin (LMWH) for VTE prophylaxis in orthopaedic trauma patients. However, emerging literature in total joint arthroplasty patients suggests the potential clinical benefits of VTE prophylaxis with aspirin. The primary aim of this trial is to compare aspirin with LMWH as a thromboprophylaxis in fracture patients. Methods and analysis PREVENT CLOT is a multicentre, randomised, pragmatic trial that aims to enrol 12 200 adult patients admitted to 1 of 21 participating centres with an operative extremity fracture, or any pelvis or acetabular fracture. The primary outcome is all-cause mortality. We will evaluate non-inferiority by testing whether the intention-to-treat difference in the probability of dying within 90 days of randomisation between aspirin and LMWH is less than our non-inferiority margin of 0.75%. Secondary efficacy outcomes include cause-specific mortality, non-fatal PE and deep vein thrombosis. Safety outcomes include bleeding complications, wound complications and deep surgical site infections. Ethics and dissemination The PREVENT CLOT trial has been approved by the ethics board at the coordinating centre (Johns Hopkins Bloomberg School of Public Health) and all participating sites. Recruitment began in April 2017 and will continue through 2021. As both study medications are currently in clinical use for VTE prophylaxis for orthopaedic trauma patients, the findings of this trial can be easily adopted into clinical practice. The results of this large, patient-centred pragmatic trial will help guide treatment choices to prevent VTE in fracture patients. Trial registration number NCT02984384.
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- 2021
9. Fixation Using Alternative Implants for the Treatment of Hip Fractures (FAITH-2): The Clinical Outcomes of a Multicenter 2 × 2 Factorial Randomized Controlled Pilot Trial in Young Femoral Neck Fracture Patients
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Andrea Howe, Lauren C. Hill, Diane Heels-Ansdell, Robert V O'Toole, Sheila Sprague, Darius Viskontas, Taryn Scott, Sofia Bzovsky, Mohit Bhandari, Greg E. Gaski, Gregory J. Della Rocca, Mauri Zomar, Gerard P. Slobogean, Krista M. Brown, Faith Investigators, Lehana Thabane, and Nathan N O'Hara
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Adult ,medicine.medical_specialty ,Nonunion ,Population ,Pilot Projects ,Placebo ,law.invention ,03 medical and health sciences ,Fracture Fixation, Internal ,0302 clinical medicine ,Randomized controlled trial ,law ,Fracture fixation ,medicine ,Humans ,Orthopedics and Sports Medicine ,education ,Femoral neck ,030222 orthopedics ,education.field_of_study ,business.industry ,Hip Fractures ,Hazard ratio ,030208 emergency & critical care medicine ,General Medicine ,medicine.disease ,Confidence interval ,Surgery ,Femoral Neck Fractures ,medicine.anatomical_structure ,Treatment Outcome ,business - Abstract
Objective To assess whether the fixation method and vitamin D supplementation affect the risk of patient-important outcomes within 12 months of injury in nongeriatric femoral neck fracture patients. Design A pilot factorial randomized controlled trial. Setting Fifteen North American clinical sites. Participants Ninety-one adults 18-60 years of age with a femoral neck fracture requiring surgical fixation. Intervention Participants were randomized to a surgical intervention (sliding hip screw or cancellous screws) and a vitamin D intervention (vitamin D3 4000 IU daily vs. placebo for 6 months). Main outcome measurements The primary clinical outcome was a composite of patient-important complications (reoperation, femoral head osteonecrosis, severe femoral neck malunion, and nonunion). Secondary outcomes included fracture-healing complications and radiographic fracture healing. Results Eighty-six participants with a mean age of 41 years were included. We found no statistically significant difference in the risk of patient-important outcomes between the surgical treatment arms (hazard ratio 0.90, 95% confidence interval 0.40-2.02, P = 0.80) and vitamin D supplementation treatment arms (hazard ratio 0.96, 95% confidence interval 0.42-2.18, P = 0.92). Conclusions These pilot trial results continue to describe the results of current fixation implants, inform the challenges of improving outcomes in this fracture population, and may guide future vitamin D trials to improve healing outcomes in young fracture populations. Although the pilot trial was not adequately powered to detect treatment effects, publishing these results may facilitate future meta-analyses on this topic. Level of evidence Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.
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- 2020
10. Fixation Using Alternative Implants for the Treatment of Hip Fractures
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Lauren C. Hill, Krista M. Brown, Robert V O'Toole, Mohit Bhandari, Sofia Bzovsky, Sheila Sprague, Greg E. Gaski, Gregory J. Della Rocca, Lehana Thabane, Andrea Howe, Mauri Zomar, Taryn Scott, Gerard P. Slobogean, Darius Viskontas, and Diane Heels-Ansdell
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medicine.medical_specialty ,Randomization ,Nutritional Supplementation ,Population ,vitamin D ,Placebo ,Femoral Neck Fractures ,femoral neck fractures ,law.invention ,Clinical/Basic Science Research Article ,Randomized controlled trial ,law ,Fracture fixation ,medicine ,clinical protocols ,education ,Femoral neck ,education.field_of_study ,business.industry ,General Medicine ,medicine.anatomical_structure ,internal ,randomized controlled trial ,Physical therapy ,fracture fixation ,business - Abstract
Objectives: To conduct a pilot trial for the Fixation using Alternative Implants for the Treatment of Hip Fractures (FAITH-2) protocol to assess feasibility of a definitive trial. Design: Pilot trial. Setting: Twenty-five clinical sites across North America and Australia were initiated, but enrolment occurred in only 15 North American sites. Patients/Participants: Ninety-one randomized adults aged 18 to 60 years with a femoral neck fracture requiring surgical fixation. Intervention: Eligible patients were randomized to receive surgical treatment (sliding hip screw or cancellous screws) AND nutritional supplementation (4000 IU of vitamin D or placebo) for 6 months postfracture. Main Outcome Measurements: Feasibility outcomes included: clinical site initiation, participant enrolment rate, proportion of participants with complete 12-month follow-up, level of data quality, and rate of protocol adherence (number of randomization errors, crossovers between treatment groups, and daily supplementation adherence). Results: Eighty-six of 91 participants randomized into the pilot trial from 15 North American hospitals were deemed eligible. Four of five primary feasibility criteria were not achieved as we were unable to initiate clinical sites outside of North America and Australia due to feasibility constraints, slow participant enrolment (60 participants recruited over 36 mo), low adherence with daily nutritional supplementation at the 6-week (72.1%), 3-month (60.5%), and 6-month (54.7%) follow-up visits, and a high loss to follow-up rate of 22.1% at 12 months. Conclusions: Despite not meeting key feasibility criteria, we increased our knowledge on the logistics and anticipated barriers when conducting vitamin D supplementation trials in this trauma population, which can be used to inform the design and conduct of future trials on this topic.
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- 2020
11. Managing work flow in high enrolling trials: The development and implementation of a sampling strategy in the PREPARE trial
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David Pogorzelski, Uyen Nguyen, Paula McKay, Lehana Thabane, Megan Camara, Lolita Ramsey, Rachel Seymour, J. Brett Goodman, Sheketha McGee, Joanne Fraifogl, Andrea Hudgins, Stephanie L. Tanner, Mohit Bhandari, Gerard P. Slobogean, Sheila Sprague, Jeffrey Wells, Jean-Claude D'Alleyrand, Anthony D. Harris, Daniel C. Mullins, Amber Wood, Gregory J. Della Rocca, Joan Hebden, Kyle J. Jeray, Lucas Marchand, Lyndsay M. O'Hara, Robert Zura, Michael J. Gardner, Jenna Blasman, Jonah Davies, Stephen Liang, Monica Taljaard, P.J. Devereaux, Gordon H. Guyatt, Diane Heels-Ansdell, Debra Marvel, Jana Palmer, Jeff Friedrich, Nathan N. O'Hara, Ms. Frances Grissom, I. Leah Gitajn, Saam Morshed, Robert V. O'Toole, Bradley A. Petrisor, Franca Mossuto, Manjari G. Joshi, Justin Fowler, Jessica Rivera, Max Talbot, Shannon Dodds, Alisha Garibaldi, Silvia Li, Alejandra Rojas, Taryn Scott, Gina Del Fabbro, Olivia Paige Szasz, Andrea Howe, Joshua Rudnicki, Haley Demyanovich, Kelly Little, C. Daniel Mullins, Michelle Medeiros, Eric Kettering, Diamond Hale, Andrew Eglseder, Aaron Johnson, Christopher Langhammer, Christopher Lebrun, Theodore Manson, Jason Nascone, Ebrahim Paryavi, Raymond Pensy, Andrew Pollak, Marcus Sciadini, Yasmin Degani, Haley K. Demyanovich, Katherine Joseph, Brad A. Petrisor, Herman Johal, Bill Ristevski, Dale Williams, Matthew Denkers, Krishan Rajaratnam, Jamal Al-Asiri, Jordan Leonard, Francesc A. Marcano-Fernández, Jodi Gallant, Federico Persico, Marko Gjorgjievski, Annie George, Roman M. Natoli, Greg E. Gaski, Todd O. McKinley, Walter W. Virkus, Anthony T. Sorkin, Jan P. Szatkowski, Joseph R. Baele, Brian H. Mullis, Lauren C. Hill, Patrick Osborn, Sarah Pierrie, Eric Martinez, Joseph Kimmel, John D. Adams, Michael L. Beckish, Christopher C. Bray, Timothy R. Brown, Andrew W. Cross, Timothy Dew, Gregory K. Faucher, Richard W. Gurich, David E. Lazarus, S. John Millon, M. Jason Palmer, Scott E. Porter, Thomas M. Schaller, Michael S. Sridhar, John L. Sanders, L. Edwin Rudisill, Michael J. Garitty, Andrew S. Poole, Michael L. Sims, Clark M. Walker, Robert M. Carlisle, Erin Adams Hofer, Brandon S. Huggins, Michael D. Hunter, William A. Marshall, Shea Bielby Ray, Cory D. Smith, Kyle M. Altman, Julia C. Bedard, Markus F. Loeffler, Erin R. Pichiotino, Austin A. Cole, Ethan J. Maltz, Wesley Parker, T. Bennett Ramsey, Alex Burnikel, Michael Colello, Russell Stewart, Jeremy Wise, M. Christian Moody, Rebecca G. Snider, Christine E. Townsend, Kayla H. Pham, Abigail Martin, Emily Robertson, Theodore Miclau, Utku Kandemir, Meir Marmor, Amir Matityahu, R. Trigg McClellan, Eric Meinberg, David Shearer, Paul Toogood, Anthony Ding, Erin Donohue, Tigist Belaye, Eleni Berhaneselase, Alexandra Paul, Kartik Garg, Joshua L. Gary, Stephen J. Warner, John W. Munz, Andrew M. Choo, Timothy S. Achor, Milton L. 'Chip' Routt, Mayank Rao, Guillermo Pechero, Adam Miller, Jennifer E. Hagen, Matthew Patrick, Richard Vlasak, Thomas Krupko, Kalia Sadasivan, Chris Koenig, Daniel Bailey, Daniel Wentworth, Chi Van, Justin Schwartz, Niloofar Dehghan, Clifford B. Jones, J Tracy Watson, Michael McKee, Ammar Karim, Michael Talerico, Debra L. Sietsema, Alyse Williams, Tayler Dykes, William T. Obremskey, Amir Alex Jahangir, Manish Sethi, Robert Boyce, Daniel J. Stinner, Phillip Mitchell, Karen Trochez, Andres Rodriguez, Vamshi Gajari, Elsa Rodriguez, Charles Pritchett, Christina Boulton, Jason Lowe, Jason Wild, John T. Ruth, Michel Taylor, Andrea Seach, Sabina Saeed, Hunter Culbert, Alejandro Cruz, Thomas Knapp, Colin Hurkett, Maya Lowney, Michael Prayson, Indresh Venkatarayappa, Brandon Horne, Jennifer Jerele, Linda Clark, Francesc Marcano-Fernández, Montsant Jornet-Gibert, Laia Martínez-Carreres, David Martí-Garín, Jorge Serrano-Sanz, Joel Sánchez-Fernández, Matsuyama Sanz-Molero, Alejandro Carballo, Xavier Pelfort, Francesc Acerboni-Flores, Anna Alavedra-Massana, Neus Anglada-Torres, Alexandre Berenguer, Jaume Cámara-Cabrera, Ariadna Caparros-García, Ferran Fillat-Gomà, Ruben Fuentes-López, Ramona Garcia-Rodriguez, Nuria Gimeno-Calavia, Guillem Graells-Alonso, Marta Martínez-Álvarez, Patricia Martínez-Grau, Raúl Pellejero-García, Ona Ràfols-Perramon, Juan Manuel Peñalver, Mònica Salomó Domènech, Albert Soler-Cano, Aldo Velasco-Barrera, Christian Yela-Verdú, Mercedes Bueno-Ruiz, Estrella Sánchez-Palomino, Ernesto Guerra, Yaiza García, Nicholas M. Romeo, Heather A. Vallier, Mary A. Breslin, Eleanor S. Wilson, Leanne K. Wadenpfuhl, Paul G. Halliday, Darius G. Viskontas, Kelly L. Apostle, Dory S. Boyer, Farhad O. Moola, Bertrand H. Perey, Trevor B. Stone, H. Michael Lemke, Mauri Zomar, Ella Spicer, Chen 'Brenda' Fan, Kyrsten Payne, Kevin Phelps, Michael Bosse, Madhav Karunakar, Laurence Kempton, Stephen Sims, Joseph Hsu, Christine Churchill, Claire Bartel, Robert Miles Mayberry, Maggie Brownrigg, Cara Girardi, Ada Mayfield, Robert A. Hymes, Cary C. Schwartzbach, Jeff E. Schulman, A. Stephen Malekzadeh, Michael A. Holzman, James S. Ahn, Farhanaz Panjshiri, Sharmistha Das, Antoinisha D. English, Sharon M. Haaser, Jaslynn A.N. Cuff, Holly Pilson, Eben A. Carroll, Jason J. Halvorson, Sharon Babcock, Martha B. Holden, Debra Bullard, Wendy Williams, Thomas F. Higgins, Justin M. Haller, David L. Rothberg, Ashley Neese, Mark Russell, Marcus Coe, Kevin Dwyer, Devin S. Mullin, Clifford A. Reilly, Peter DePalo, Amy E. Hall, Marilyn Heng, Mitchel B. Harris, R. Malcolm Smith, David W. Lhowe, John G. Esposito, Mira Bansal, Patrick F. Bergin, George V. Russell, Matthew L. Graves, John Morellato, Heather K. Champion, Leslie N. Johnson, Sheketha L. McGee, Eldrin L. Bhanat, Samir Mehta, Derek Donegan, Jaimo Ahn, Annamarie Horan, Mary Dooley, Ashley Kuczinski, Ashley Iwu, David Potter, Robert VanDemark, Branden Pfaff, Troy Hollinsworth, Michael J. Weaver, Arvind G. von Keudell, Michael F. McTague, Elizabeth M. Allen, Todd Jaeblon, Robert Beer, Mark J. Gage, Rachel M. Reilly, and Cindy Sparrow
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Pragmatic ,medicine.medical_specialty ,Comparative effectiveness research ,Pharmacy ,Sampling framework ,Cluster crossover ,Sampling strategy ,Article ,Odds ,03 medical and health sciences ,0302 clinical medicine ,Health care ,medicine ,030212 general & internal medicine ,Sampling ,Pharmacology ,lcsh:R5-920 ,Descriptive statistics ,business.industry ,Sampling (statistics) ,General Medicine ,Test (assessment) ,Work flow ,Family medicine ,business ,lcsh:Medicine (General) ,030217 neurology & neurosurgery - Abstract
Author(s): 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; 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 and PREPARE; Aqueous-PREP; PREPARE; PREP-IT Investigators Executive Committee | 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 l 0.001).ConclusionsImplementing a sampling strategy in the PREPARE trial has helped to limit the number of missed eligible patients. This sampling strategy represents a simple, easy to use tool for managing work flow at clinical sites and maintaining the integrity of a large trial.
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- 2020
12. Locking Plate Fixation in a Series of Bicondylar Tibial Plateau Fractures Raises Treatment Costs Without Clinical Benefit
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Richard Rosales, Matthew Cavallero, Walter W. Virkus, Greg E. Gaski, Jesse Caballero, and Laurence B. Kempton
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Male ,medicine.medical_specialty ,Radiography ,Nonunion ,Knee Injuries ,Menisci, Tibial ,Cohort Studies ,Fracture Fixation, Internal ,03 medical and health sciences ,Fixation (surgical) ,0302 clinical medicine ,Trauma Centers ,Fracture fixation ,Humans ,Medicine ,Orthopedics and Sports Medicine ,Patient Reported Outcome Measures ,Retrospective Studies ,Fracture Healing ,Academic Medical Centers ,030222 orthopedics ,business.industry ,Trauma center ,030208 emergency & critical care medicine ,Retrospective cohort study ,Equipment Design ,Health Care Costs ,General Medicine ,medicine.disease ,Surgery ,Tibial Fractures ,Treatment Outcome ,Female ,Implant ,business ,Bone Plates ,Cohort study - Abstract
Objectives To compare outcomes and costs between locking and nonlocking (NL) constructs in the treatment of bicondylar tibial plateau (BTP) fractures. Design Retrospective cohort study. Setting Level 1 academic trauma center. Patients All patients who presented with complete articular, BTP fractures OTA/AO 41-C and Schatzker VI between 2013 and 2015 were screened (n = 112). Patients treated with a mode of fixation other than plate-and-screw were excluded. Fifty-six patients with a minimum follow-up of 12 months were included in the analysis. Intervention Operative fixation of BTP fractures with locking (n = 29) or NL (n = 27) implants. Main outcome measurements Implant cost, patient-reported outcomes (PROMIS physical function and pain interference), clinical, and radiographic outcomes. Results There were no differences between the 2 groups with respect to demographics, injury characteristics, radiographic outcomes (change in alignment), or clinical outcomes (PROMIS, reoperation, nonunion, and infection). Implant costs were significantly greater in the locking group compared with the NL group (mean L, $4453; mean NL, $2569; P Conclusions This study demonstrated improved value of treatment (less cost with no difference in clinical outcome) with NL implants for BTP fractures when dual-plate fixation strategies are performed. Level of evidence Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.
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- 2018
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13. Precision Medicine Applications to Manage Multiply Injured Patients With Orthopaedic Trauma
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Felipe A Lisboa, Samir Mehta, Greg E. Gaski, Annamarie D. Horan, and Todd O. McKinley
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medicine.medical_specialty ,Nonunion ,Psychological intervention ,MEDLINE ,03 medical and health sciences ,Fractures, Bone ,0302 clinical medicine ,medicine ,Humans ,Orthopedics and Sports Medicine ,Orthopedic Procedures ,Disease management (health) ,Precision Medicine ,Intensive care medicine ,Orthopaedic trauma ,030222 orthopedics ,business.industry ,Multiple Trauma ,Disease Management ,030208 emergency & critical care medicine ,General Medicine ,medicine.disease ,Precision medicine ,Polytrauma ,Orthopedics ,Orthopedic surgery ,Surgery ,business - Abstract
Precision medicine offers potential for improved outcomes by tailoring interventions based on patient-specific demographics and disease-specific data. Precision methods are relatively unexplored in trauma patients. New research is being looked at for precision methods to treat patients with large extremity wounds, nonunions, and fractures associated with polytrauma. Precision-based clinical decision tools are being validated to optimize timing for open wound definitive closure. Early patient-specific biomarkers to stratify nonunion risk within 1 week of fracture are being explored. Patient-specific data to stage timing of major fracture interventions in multiply injured patients are being interrogated.
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- 2019
14. Early Immunologic Response in Multiply Injured Patients With Orthopaedic Injuries Is Associated With Organ Dysfunction
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Krista M. Brown, Cameron Metzger, Timothy R. Billiar, Yoram Vodovotz, Todd O. McKinley, Andrew Cutshall, Tyler McCarroll, Robert P. Wessel, Greg E. Gaski, and Jeremy Adler
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Adult ,Male ,medicine.medical_specialty ,Time Factors ,Adolescent ,Multiple Organ Failure ,law.invention ,03 medical and health sciences ,Young Adult ,0302 clinical medicine ,Injury Severity Score ,law ,Internal medicine ,medicine ,Humans ,Orthopedics and Sports Medicine ,Prospective Studies ,Young adult ,Prospective cohort study ,030222 orthopedics ,business.industry ,Multiple Trauma ,Organ dysfunction ,Trauma center ,030208 emergency & critical care medicine ,General Medicine ,Middle Aged ,medicine.disease ,Prognosis ,Intensive care unit ,Polytrauma ,Biomarker (medicine) ,Cytokines ,Surgery ,Female ,medicine.symptom ,business ,Biomarkers ,Follow-Up Studies - Abstract
Objectives To quantify the acute immunologic biomarker response in multiply injured patients with axial and lower extremity fractures and to explore associations with adverse short-term outcomes including organ dysfunction and nosocomial infection (NI). Design Prospective cohort study. Setting Level 1 academic trauma center. Patients Consecutive multiply injured patients, 18-55 years of age, with major pelvic and lower extremity orthopaedic injuries (all pelvic/acetabular fractures, operative femur and tibia fractures) that presented as a trauma activation and admitted to the intensive care unit from April 2015 through October 2016. Sixty-one patients met inclusion criteria. Intervention Blood was collected upon presentation to the hospital and at the following time points: 8, 24, 48 hours, and daily during intensive care unit admission. Blood was processed by centrifugation, separation into 1.0-mL plasma aliquots, and cryopreserved within 2 hours of collection. Main outcome measurements Plasma analyses of protein levels of cytokines/chemokines were performed using a Luminex panel Bioassay of 20 immunologic mediators. Organ dysfunction was measured by the Marshall Multiple Organ Dysfunction score (MODScore) and nosocomial infection (NI) was recorded. Patients were stratified into low (MODS ≤ 4; n = 34) and high (MODS > 4; n = 27) organ dysfunction groups. Results The MODS >4 group had higher circulating levels of interleukin (IL)-6, IL-8, IL-10, monocyte chemoattractant protein-1 (MCP-1), IL-1 receptor antagonist (IL-1RA), and monokine induced by interferon gamma (MIG) compared with the MODS ≤4 group at nearly all time points. MODS >4 exhibited lower levels of IL-21 and IL-22 compared with MODS ≤4. Patients who developed NI (n = 24) had higher circulating concentrations of IL-10, MIG, and high mobility group box 1 (HMGB1) compared with patients who did not develop NI (n = 37). Conclusions Temporal quantification of immune mediators identified 8 biomarkers associated with greater levels of organ dysfunction in polytrauma patients with major orthopaedic injuries. Level of evidence Prognostic Level II. See Instructions for Authors for a complete description of levels of evidence.
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- 2019
15. Large-magnitude Pelvic and Retroperitoneal Tissue Damage Predicts Organ Failure
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Greg E. Gaski, Travis Frantz, Scott D. Steenburg, Teresa M. Bell, and Todd O. McKinley
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Adult ,Male ,medicine.medical_specialty ,Adolescent ,Databases, Factual ,Multiple Organ Failure ,Risk Assessment ,Medical Records ,Pelvis ,Young Adult ,03 medical and health sciences ,Injury Severity Score ,0302 clinical medicine ,Predictive Value of Tests ,Risk Factors ,Tissue damage ,medicine ,Humans ,Retroperitoneal space ,Orthopedics and Sports Medicine ,Retroperitoneal Space ,Aged ,Retrospective Studies ,030222 orthopedics ,Multiple Trauma ,business.industry ,Organ dysfunction ,Symposium: Current Issues in Orthopaedic Trauma: Tribute to Clifford H. Turen ,030208 emergency & critical care medicine ,Retrospective cohort study ,General Medicine ,Middle Aged ,Prognosis ,Surgery ,Early Diagnosis ,medicine.anatomical_structure ,Predictive value of tests ,Orthopedic surgery ,Female ,medicine.symptom ,Tomography, X-Ray Computed ,business - Abstract
Pelvic and retroperitoneal trauma is a major cause of morbidity and mortality in multiply injured patients. The Injury Severity Score (ISS) has been criticized for underrepresenting and inaccurately defining mechanical injury. The influence of pelvic injury volume on organ dysfunction and multiple organ failure (MOF) has not been described. Through the use of CT, this investigation sought to precisely define volumes of mechanical tissue damage by anatomic region and examine its impact on organ failure.(1) Do patients with MOF have a greater volume of pelvic and retroperitoneal tissue damage when compared with those without MOF? (2) In patients who sustained pelvic trauma, does the magnitude of pelvic injury differ in patients with MOF? (3) Does the magnitude of organ dysfunction correlate with pelvic tissue damage volume?Seventy-four multiply injured patients aged 18 to 65 years with an ISS ≥ 18 admitted to the intensive care unit for a minimum of 6 days with complete admission CT scans were analyzed. Each identifiable injury in the head/neck, chest, abdomen, and pelvis underwent volumetric determination using CT to generate regional tissue damage volume scores. Primary outcomes were the development of MOF as measured by the Denver MOF score and the degree of organ dysfunction by utilization of the Sequential Organ Failure Assessment (SOFA) score. Mean pelvic and retroperitoneal tissue damage volumes were compared in patients who developed MOF and those who did not develop MOF using Student's t-test. Among patients who sustained pelvic injuries, we compared mean volume of tissue damaged in patients who developed MOF and those who did not. We assessed whether there was a correlation between organ dysfunction, as measured by the SOFA score as a continuous variable, and the volume of pelvic and retroperitoneal tissue damage using the Pearson product-moment correlation coefficient.The average volume of tissue damage was greater in patients with MOF when compared with those without (MOF: 685.667 ± 1081.344; non-MOF: 195.511 ± 381.436; mean difference 490.156 cc [95% confidence interval {CI}, 50.076-930.237 cc], p = 0.030). Among patients who sustained pelvic injuries, those with MOF had higher average tissue damage volumes than those without MOF (MOF: 1322.000 ± 1197.050; non-MOF: 382.750 ± 465.005; mean difference 939.250 [95% CI, 229.267-1649.233], p = 0.013). Organ dysfunction (SOFA score) correlated with higher volumes of pelvic tissue damage (r = 0.570, p0.001).This investigation demonstrated that greater degrees of pelvic and retroperitoneal tissue damage calculated from injury CT scans in multiply injured patients is associated with more severe organ dysfunction and an increased risk of developing MOF. Early identification of polytrauma patients at risk of MOF allows clinicians to implement appropriate resuscitative strategies early in the disease course. Improved stratification of injury severity and a patient's anticipated clinical course may aid in the planning and execution of staged orthopaedic interventions. Future avenues of study should incorporate the ischemic/hypoperfusion component of pelvic injury in conjunction with the mechanical component presented here for improved stratification of multiply injured patients at higher risk of MOF.Level III, prognostic study.
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- 2016
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16. Insights into the association between coagulopathy and inflammation: abnormal clot mechanics are a warning of immunologic dysregulation following major injury
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Stephanie A. Savage, Timothy R. Billiar, Greg E. Gaski, Ruben Zamora, Rami A. Namas, Rachael A. Callcut, Tyler McCarroll, Yoram Vodovotz, Todd O. McKinley, and Ben L. Zarzaur
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medicine.medical_specialty ,Inflammation ,blood clotting ,law.invention ,Clinical Research ,law ,Internal medicine ,medicine ,Coagulopathy ,2.1 Biological and endogenous factors ,Major injury ,Aetiology ,medicine.diagnostic_test ,business.industry ,Accidental injury ,disseminated coagulation ,thromboelastography ,General Medicine ,medicine.disease ,Intensive care unit ,Thromboelastography ,inflammation ,Blunt trauma ,Shock (circulatory) ,Injury (total) Accidents/Adverse Effects ,Cardiology ,Original Article ,intravascular ,medicine.symptom ,business ,Perfusion - Abstract
Background Severe injury initiates a complex physiologic response encompassing multiple systems and varies phenotypically between patients. Trauma-induced coagulopathy may be an early warning of a poorly coordinated response at the molecular level, including a deleterious immunologic response and worsening of shock states. The onset of trauma-induced coagulopathy (TIC) may be subtle however. In previous work, we identified an early warning sign of coagulopathy from the admission thromboelastogram, called the MAR ratio. We hypothesized that a low MAR ratio would be associated with specific derangements in the inflammatory response. Methods In this prospective, observational study, 88 blunt trauma patients admitted to the intensive care unit (ICU) were identified. Concentrations of inflammatory mediators were recorded serially over the course of a week and the MAR ratio was calculated from the admission thromboelastogram. Correlation analysis was used to assess the relationship between MAR and inflammatory mediators. Dynamic network analysis was used to assess coordination of immunologic response. Results Seventy-nine percent of patients were male and mean age was 37 years (SD 12). The mean ISS was 30.2 (SD 12) and mortality was 7.2%. CRITICAL patients (MAR ratio ≤14.2) had statistically higher shock volumes at three time points in the first day compared to NORMAL patients (MAR ratio >14.2). CRITICAL patients had significant differences in IL-6 (P=0.0065), IL-8 (P=0.0115), IL-10 (P=0.0316) and MCP-1 (P=0.0039) concentrations compared to NORMAL. Differences in degree of expression and discoordination of immune response continued in CRITICAL patients throughout the first day. Conclusions The admission MAR ratio may be the earliest warning signal of a pathologic inflammatory response associated with hypoperfusion and TIC. A low MAR ratio is an early indication of complicated dysfunction of multiple molecular processes following trauma.
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- 2020
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17. Diagnosis and Management of Polytraumatized Patients With Severe Extremity Trauma
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Yoram Vodovotz, Todd O. McKinley, Greg E. Gaski, Timothy R. Billiar, and Benjamin T. Corona
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0301 basic medicine ,medicine.medical_specialty ,Soft Tissue Injuries ,Nonunion ,Osteoarthritis ,Injury response ,03 medical and health sciences ,0302 clinical medicine ,Response to injury ,medicine ,Humans ,Orthopedics and Sports Medicine ,Intensive care medicine ,Muscle loss ,business.industry ,Multiple Trauma ,Osteomyelitis ,030208 emergency & critical care medicine ,Extremities ,General Medicine ,medicine.disease ,030104 developmental biology ,Tissue ischemia ,Surgery ,business ,Surgical interventions - Abstract
Multiply injured patients with severe extremity trauma are at risk of acute systemic complications and are at high risk of developing longer term orthopaedic complications including soft-tissue infection, osteomyelitis, posttraumatic osteoarthritis, and nonunion. It is becoming increasingly recognized that injury magnitude and response to injury have major jurisdiction pertaining to patient outcomes and complications. The complexities of injury and injury response that affect outcomes present opportunities to apply precision approaches to understand and quantify injury magnitude and injury response on a patient-specific basis. Here, we present novel approaches to measure injury magnitude by adopting methods that quantify both mechanical and ischemic tissue injury specific to each patient. We also present evolving computational approaches that have provided new insight into the complexities of inflammation and immunologic response to injury specific to each patient. These precision approaches are on the forefront of understanding how to stratify individualized injury and injury response in an effort to optimize titrated orthopaedic surgical interventions, which invariably involve most of the multiply injured patients. Finally, we present novel methods directed at mangled limbs with severe soft-tissue injury that comprise severely injured patients. Specifically, methods being developed to treat mangled limbs with volumetric muscle loss have the potential to improve limb outcomes and also mitigate uncompensated inflammation that occurs in these patients.
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- 2018
18. Building a Clinical Research Network in Trauma Orthopaedics: The Major Extremity Trauma Research Consortium (METRC)
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Andrew R. Burgess, Lisa K. Cannada, Wade T. Gordon, Michael J. Bosse, Reza Firoozabadi, Janet Wells, H. Claude Sagi, Kathy Carl, Paul M. Lafferty, Michael T. Mazurek, Rachel B. Seymour, Jerald R. Westberg, Jason W. Nascone, Todd O. McKinley, Brian O. Westerlind, Cesar S. Molina, Theodore T. Manson, Christopher S. Smith, Gregory A. Zych, Hope Carlisle, Daniel O. Scharfstein, Medardo R. Maroto, Hassan R. Mir, Paul Tornetta, Gregory de Lissovoy, George V Russell, Daniel J. Stinner, Kevin M Kuhn, Clifford B. Jones, J. Tracy Watson, Mary Zadnik-Newell, James A. Keeney, John J. Keeling, Dana J. Farrell, Corey Henderson, Greg E. Gaski, Bruce J. Sangeorzan, Patrick M. Osborn, Robert V O'Toole, Matthew D. Karam, Martha B. Holden, Andrew N. Pollak, Marcus F. Sciadini, Tigist Belaye, J. Spence Reid, Andrew H. Schmidt, Dennis W. Mann, David Teague, James R. Ficke, Heather Silva, Lauren E. Allen, Brendan M. Patterson, Robert D. Teasdall, Theodore Miclau, Madhav A. Karunakar, Hannah Gissel, Lori Smith, Alysse J Boyd, J. Brett Goodman, Joshua R. Langford, Patrick F. Bergin, James Toledano, Andrew R. Evans, Renan C. Castillo, Eben A. Carroll, Ellen J. MacKenzie, Xochitl Ceniceros, Joshua L. Gary, Paula Harriott, J. Lawrence Marsh, Dinorah Rodriguez, Saam Morshed, Henry A. Boateng, Joseph R. Hsu, Christine Churchill, David J. Hak, Anthony R. Carlini, Roman A. Hayda, Terrence J. Endres, Daniel S. Chan, Rachel Holthaus, Sarah B. Langensiepen, Debra L. Sietsema, James J. Hutson, Pamela M. Warlow, Barbara Steverson, Lisa Reider, Kristin R. Archer, Stephen H. Sims, Katherine Frey, Amy Nelson, Kathy Franco, Roy Sanders, Daniel V. Unger, Heather A. Vallier, William T. Obremskey, and Joseph C. Wenke
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Male ,medicine.medical_specialty ,Quality Assurance, Health Care ,03 medical and health sciences ,0302 clinical medicine ,Trauma Centers ,medicine ,Civil Rights ,Humans ,Orthopedics and Sports Medicine ,030212 general & internal medicine ,Program Development ,030222 orthopedics ,business.industry ,Multiple Trauma ,Trauma research ,Extremities ,General Medicine ,medicine.disease ,Organizational Innovation ,United States ,Health Planning ,Clinical research ,Military Personnel ,Emergency medicine ,Surgery ,Female ,Trauma orthopaedics ,Medical emergency ,business ,Program Evaluation - Abstract
Lessons learned from battle have been fundamental to advancing the care of injuries that occur in civilian life. Equally important is the need to further refine these advances in civilian practice, so they are available during future conflicts. The Major Extremity Trauma Research Consortium (METRC) was established to address these needs.METRC is a network of 22 core level I civilian trauma centers and 4 core military treatment centers-with the ability to expand patient recruitment to more than 30 additional satellite trauma centers for the purpose of conducting multicenter research studies relevant to the treatment and outcomes of orthopaedic trauma sustained in the military. Early measures of success of the Consortium pertain to building of an infrastructure to support the network, managing the regulatory process, and enrolling and following patients in multiple studies.METRC has been successful in maintaining the engagement of several leading, high volume, level I trauma centers that form the core of METRC; together they operatively manage 15,432 major fractures annually. METRC is currently funded to conduct 18 prospective studies that address 6 priority areas. The design and implementation of these studies are managed through a single coordinating center. As of December 1, 2015, a total of 4560 participants have been enrolled.Success of METRC to date confirms the potential for civilian and military trauma centers to collaborate on critical research issues and leverage the strength that comes from engaging patients and providers from across multiple centers.
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- 2016
19. In Brief: Classifications in Brief: Vancouver Classification of Postoperative Periprosthetic Femur Fractures
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Sean P. Scully and Greg E. Gaski
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Reoperation ,Vancouver classification ,medicine.medical_specialty ,Arthroplasty, Replacement, Hip ,medicine.medical_treatment ,Dentistry ,Periprosthetic ,Prosthesis ,In Brief ,Decision Support Techniques ,Humans ,Medicine ,Internal fixation ,Orthopedics and Sports Medicine ,Femur ,Hip fracture ,business.industry ,Patient Selection ,Mortality rate ,General Medicine ,medicine.disease ,Surgery ,Orthopedic surgery ,business ,Femoral Fractures ,Algorithms - Abstract
With a growing elderly population, the rates of primary and revision THAs also have increased. Paralleling the increased number of hip reconstructive procedures performed is the incidence of periprosthetic femur fractures [14]. Each periprosthetic fracture poses a unique challenge to the treating orthopaedic surgeon because of the many variables that must be considered with each fracture pattern. These variables include the relationship of the fracture to the implant, the specifics of the implant including wear, and the functional demands of the patient. A couple studies outline the impact of periprosthetic femur fractures on mortality. Lindahl et al. investigated outcomes in patients from the Swedish national hip arthroplasty register and described higher mortality rates after surgery for patients with periprosthetic femoral fractures compared with patients who had total hip replacements [16]. Bhattacharyya et al. similarly found an increased mortality rate of 11% at 1 year (21% cumulative mortality rate) in patients treated operatively for periprosthetic femur fractures compared with a rate of 2.9% in patients who underwent primary joint arthroplasties [3]. They recorded mortality rates approaching those documented after hip fracture (16.5%), and also noted a nearly threefold increase in mortality in patients who sustained a fracture at the level of the prosthesis and were treated with open reduction and internal fixation versus patients treated with revision arthroplasty [3]. The Vancouver classification developed by Duncan and Masri [10] and Masri et al. [17] is the most widely accepted classification scheme to group fractures with similar characteristics from which a treatment algorithm is derived. Previous classification schemes and treatment algorithms for periprosthetic femur fractures focused primarily on location, fracture pattern, implant stability, and/or potential for loosening [2, 7, 13, 18, 21]. The Vancouver classification assimilates three key factors: location, stability of the implant, and the surrounding bone stock (Table 1). The classification has since been modified by Masri et al. to include intraoperative in addition to postoperative periprosthetic femur fractures [17]. The remainder of this discussion will focus on the Vancouver classification of postoperative periprosthetic femur fractures.
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- 2011
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20. Nonoperative treatment of intermediate severity lateral compression type 1 pelvic ring injuries with minimally displaced complete sacral fracture
- Author
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Theodore T. Manson, Greg E. Gaski, Renan C. Castillo, Gerard P. Slobogean, and Robert V OʼToole
- Subjects
Adult ,Male ,medicine.medical_specialty ,Sacrum ,Adolescent ,Fractures, Bone ,Young Adult ,X ray computed ,Pelvic ring ,Fractures, Compression ,medicine ,Humans ,Orthopedics and Sports Medicine ,In patient ,Pelvic Bones ,Aged ,Retrospective Studies ,business.industry ,General Medicine ,Recovery of Function ,Middle Aged ,Compression therapy ,medicine.disease ,Lateral compression ,Sacral fracture ,Nonoperative treatment ,Surgery ,Pelvic fracture ,Spinal Fractures ,Female ,business ,Tomography, X-Ray Computed - Abstract
Controversy exists regarding optimum management of lateral compression type 1 (LC1) pelvic ring injuries (OTA type 61-B2.1), particularly in patients with complete sacral fractures. We hypothesized that nonoperative treatment would result in acceptable functional outcomes.Database review.Level I trauma center.We identified patients treated for LC1 fractures (n = 406) from 2007 to 2011 and analyzed a subset of LC1 injuries of "intermediate severity" characterized by complete sacral fracture with less than 1 cm initial displacement (n = 104).Fifty patients were contacted for functional outcome assessment at average follow-up of 33 months.Majeed pelvic score and physical component summary (PCS) score and mental component summary (MCS) score of 12-item Short-Form Health Survey version 2.Average Majeed pelvic score was 85.5, yielding 33 excellent, 9 good, 5 fair, and 3 poor outcomes. Mean PCS and MCS scores were 48.8 and 48.9, respectively (both confidence intervals include 50, the score for a healthy normative population). Patients with lower extremity injuries had a trend toward lower PCS and MCS and statistically significant lower mean Majeed scores (P = 0.01). Thirty-five of 37 patients without lower extremity injury had good or excellent categorical outcomes based on Majeed scores. No significant differences were observed regarding weight-bearing status, extent of anterior ring injury, or injury severity score. Radiographic follow-up was available for 36 of 50 patients. No fracture was displaced1 cm.Acceptable functional outcomes can be expected after nonsurgical management of LC1 pelvic injuries with complete sacral fracture and less than 1 cm initial displacement.Therapeutic level IV.
- Published
- 2014
21. An academic center's delivery of care after the Haitian earthquake
- Author
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John M Macdonald, Enrique Ginzburg, Lazara Barreras-Pagan, William W. O'Neill, Michael A. Kolber, Steven Falcone, Amir K. Jaffer, Mario A Reyes, Ralf E. Gebhard, Rafael Campo, Barth A. Green, and Greg E. Gaski
- Subjects
Gerontology ,Volunteers ,Higher education ,Poison control ,Disasters ,Hospitals, University ,Disaster area ,Health care ,Internal Medicine ,Earthquakes ,Medicine ,Humans ,Natural disaster ,business.industry ,Hospitals, Packaged ,General Medicine ,Public relations ,Miami ,Relief Work ,Haiti ,Software deployment ,General partnership ,Florida ,Triage ,business ,Delivery of Health Care ,Forecasting - Abstract
The Miller School of Medicine of the University of Miami and Project Medishare, an affiliated not-for-profit organization, provided a large-scale relief effort in Haiti after the earthquake of 12 January 2010. Their experience demonstrates that academic medical centers in proximity to natural disasters can help deliver effective medical care through a coordinated process involving mobilization of their own resources, establishment of focused management teams at home and on the ground with formal organizational oversight, and partnership with governmental and nongovernmental relief agencies. Proximity to the disaster area allows for prompt arrival of medical personnel and equipment. The recruitment and organized deployment of large numbers of local and national volunteers are indispensable parts of this effort. Multidisciplinary teams on short rotations can form the core of the medical response.
- Published
- 2010
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