Browsing by Author "Pogorzelski, David"
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Item Correction to: Cluster identification, selection, and description in Cluster randomized crossover trials: the PREP-IT trials(BioMed Central, 2020-09-30) Sprague, Sheila; Scott, Taryn; Dodds, Shannon; Pogorzelski, David; McKay, Paula; Harris, Anthony D.; Wood, Amber; Thabane, Lehana; Bhandari, Mohit; Mehta, Samir; Gaski, Greg; Boulton, Christina; Marcano-Fernández, Francesc; Guerra-Farfán, Ernesto; Hebden, Joan; O’Hara, Lyndsay M.; Slobogean, Gerard P.; 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, 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.; Lazarus, David E.; Millon, S. John; Palmer, M. Jason; Porter, Scott E.; Schaller, Thomas M.; Sridhar, Michael S.; Sanders, John L.; Rudisill, L. Edwin; Garitty, Michael J.; Poole, Andrew S.; Sims, Michael L.; Walker, Clark M.; Carlisle, Robert M.; 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.; Routt, Milton L. “ Chip”; 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-Farfán, 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; on behalf of the PREP-IT Investigators; Orthopaedic Surgery, School of MedicineAn amendment to this paper has been published and can be accessed via the original article.Item Managing work flow in high enrolling trials: The development and implementation of a sampling strategy in the PREPARE trial(Elsevier, 2021-01-23) 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; Orthopaedic Surgery, School of MedicineIntroduction: Pragmatic 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. Methods: Given 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. Results: 7 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 < 0.001). Conclusions: Implementing 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.Item Patient and stakeholder engagement learnings: PREP-IT as a case study(Future Medicine, 2021-04) Medeiros, Michelle; Love, T Rosie; Slobogean, Gerard P.; Sprague, Sheila; Perfetto, Eleanor M.; O'Hara, Nathan N.; Mullins, C. Daniel; Slobogean, Gerard P.; Sprague, Sheila; Wells, Jeffrey; Bhandari, Mohit; D'alleyrand, Jean-Claude; Harris, Anthony; 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, Pj; Guyatt, Gordon H.; Heels-Ansdell, Dianne; Marvel, Debra; Palmer, Jana; Friedrich, Jeff; O'Hara, Nathan; Grissom, Frances; Gitajn, Leah; Morshed, Saam; O'Toole, Robert; 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 Page; McKay, Paula; Howe, Andrea; Rudnicki, Joshua; Demyanovich, Haley; Little, Kelly; Medeiros, Michellic; Kettering, Eric; Hale, Diamond; Polk, Genevieve; Mahal, Nirmen; Eglseder, Andrew; Johnson, Aaron; Langhammer, Christopher; Lebrun, Christopher; Manson, Theodore; Nascone, Jason; Paryavi, Ebrahim; Pensy, Raymond; Pollack, Andrew; Sciadini, Marcus; Degani, Yasmin; Joseph, Katherine; 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; Fowler, Justin; Pierrie, Sarah; Martinez, Eric; Kimmel, Joseph; Adams, John D.; Beckish, Michael; Bray, Christopher; Brown, Timothy R.; Cross, Andrew W.; Dew, Timothy; Faucher, Gregory; Gurich Jr, Richard W.; Lazarus, David E.; Millon, S. John; 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 II, Robert M.; 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; Routt, Milton L. "Chip"; 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.; William, 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, Chris; Boulton, Christina; Lowe, Jason; Wild, Jason; Ruth, John T.; Taylor, Michel; Seach, Andrea; Saeed, Sabina; Culbert, Hunter; Crus, 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-Clavia, Nuria; Graells-Alonso, Guillem; Martínez-álvarez, Marta; Martínez-Grau, Patricia; Pellejero-García, Raúl; Ràfols-Perramon, Ona; Peñalver, Juan Manuel; Salomò Domènech, Mònica; Soler-Cano, Albert; Velasco-Barrera, Aldo; Yela-Verdú, Christian; Bueno-Ruiz, Mercedes; Sánchez-Palomino, Estrella; Guerra-Farfán, 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.; Reily, Clifford A; DePalo, Peter; Hall, Amy E.; Heng, Marilyn; Harris, Mitchel B.; Smith, R. Malcolm; Lhowe, David W.; Esposito, John; Bansal, Mira; Bergin, Patrick F.; Russell, George V.; Graves, Matthew L.; Morellato, John; Champion, Heather K.; Johnson, Leslie N.; McGee, Skeketha L.; Bhanat, Eldrin L.; Mehta, Samir; Donegan, Derek; Ahn, Jaimo; Horan, Annamarie; Dooley, Mary; Kuczinski, Ashley; Iwu, Ashley; Potter, David; VanDemark II, Robert; Pfaff, Branden; Hollinsworth, Troy; Weaver, Michael J.; von Keudel, Arvind G.; McTague, Michael F.; Allen, Elizabeth M.; Jaeblon, Todd; Beer, Robert; Gage, Mark J.; Reilly, Rachel M.; Sparrow, Cindy; Paniagua, Ariana; Orthopaedic Surgery, School of MedicineItem The impact of heterotopic ossification prophylaxis after surgical fixation of acetabular fractures: national treatment patterns and related outcomes(Elsevier, 2023-03-06) Boissonneault, Adam; O’Hara, Nathan; Pogorzelski, David; Marchand, Lucas; Higgins, Thomas; Gitajn, Leah; Gage, Mark J.; Natoli, Roman M.; Sharma, Ishani; Pierrie, Sarah; O’Toole, Robert V.; Sprague, Sheila; Slobogean, Gerard; PREP-IT Investigators; Orthopaedic Surgery, School of MedicineBackground: Heterotopic ossification (HO) is a common complication after surgical fixation of acetabular fractures. Numerous strategies have been employed to prevent HO formation, but results are mixed and optimal treatment strategy remains controversial. The purpose of the study was to describe current national heterotopic ossification (HO) prophylaxis patterns among academic trauma centers, determine the association between prophylaxis type and radiographic HO, and identify if heterogeneity in treatment effects exist based on outcome risk strata. Methods: We used data from a subset of participants enrolled in the Pragmatic Randomized Trial Evaluating Pre-Operative Alcohol Skin Solutions in Fractured Extremities (PREPARE) trial. We included only patients with closed AO-type 62 acetabular fractures that were surgically treated via a posterior (Kocher-Langenbeck), combined anterior and posterior, or extensile exposure. PREPARE Clinical Trial Registration Number: NCT03523962 Patient population This cohort study was nested within the Pragmatic Randomized Trial Evaluating Pre-Operative Alcohol Skin Solutions in Fractured Extremities (PREPARE) trial. The PREPARE trial is a multicenter cluster-randomized crossover trial evaluating the effectiveness of two alcohol-based pre-operative antiseptic skin solutions. All PREPARE trial clinical centers that enrolled at least one patient with a closed AO-type 62 acetabular fracture were invited to participate in the nested study. Results: 277 patients from 20 level 1 and level 2 trauma centers in the U.S. and Canada were included in this study. 32 patients (12%) received indomethacin prophylaxis, 100 patients (36%) received XRT prophylaxis, and 145 patients (52%) received no prophylaxis. Administration of XRT was associated with a 68% reduction in the adjusted odds of overall HO (OR 0.32, 95% CI, 0.14 - 0.69, p = 0.005). The overall severe HO (Brooker classes III or IV) rate was 8% for the entire cohort; XRT reduced the rate of severe HO in high-risk patients only (p=0.03). Conclusion: HO prophylaxis patterns after surgical fixation of acetabular fractures have changed dramatically over the last two decades. Most centers included in this study did not administer HO prophylaxis. XRT was associated with a marked reduction in the rate of overall HO and the rate of severe HO in high-risk patients. Randomized trials are needed to fully elucidate the potential benefit of XRT.