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Managing work flow in high enrolling trials: The development and implementation of a sampling strategy in the PREPARE trial.
Pogorzelski D, Nguyen U, McKay P, Thabane L, Camara M, Ramsey L, Seymour R, Goodman JB, McGee S, Fraifogl J, Hudgins A, Tanner SL, Bhandari M, Slobogean GP, Sprague S; 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. Pogorzelski D, et al. Among authors: fraifogl j. Contemp Clin Trials Commun. 2021 Jan 23;21:100730. doi: 10.1016/j.conctc.2021.100730. eCollection 2021 Mar. Contemp Clin Trials Commun. 2021. PMID: 33605946 Free PMC article.
Implementing stakeholder engagement to explore alternative models of consent: An example from the PREP-IT trials.
Pechero G Jr, Pfaff B, Rao M, Pogorzelski D, McKay P, Spicer E, Howe A, Demyanovich HK, Sietsema DL, McTague MF, Ramsey L, Holden M, Rudnicki J, Wells J, Medeiros M, Slobogean GP, Sprague S; PREP-IT Investigators; Slobogean GP, Sprague S, Wells J, Bhandari M; 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; O'Toole RV, D'Alleyrand JC, Eglseder A, Johnson A, Langhammer C, Lebrun C, Manson T, Nascone J, Paryavi E, Pensy R, Pollak A, Sciadini M, Slobogean GP, Degani Y, Demyanovich HK, Howe A, O'Hara NN, Joseph K, Rudnicki J, Camara M; Aqueous-PREP and PREPARE; Aqueous-PREP; PREPARE. Pechero G Jr, et al. Contemp Clin Trials Commun. 2021 Jun 14;22:100787. doi: 10.1016/j.conctc.2021.100787. eCollection 2021 Jun. Contemp Clin Trials Commun. 2021. PMID: 34195467 Free PMC article.
The impact of COVID-19 restrictions on participant enrollment in the PREPARE trial.
Pogorzelski D, McKay P, Weaver MJ, Jaeblon T, Hymes RA, Gaski GE, Fraifogl J, Ahn JS, Bzovsky S, Slobogean G, Sprague S, Slobogean GP, Sprague S, Wells J, Bhandari M, O'Toole RV, D'Alleyrand JC, Eglseder A, Johnson A, Langhammer C, Lebrun C, Nascone J, Pensy R, Pollak A, Sciadini M, Slobogean GP, Degani Y, Demyanovich HK, Howe A, O'Hara NN, Phipps H, Hempen E. Pogorzelski D, et al. Among authors: fraifogl j. Contemp Clin Trials Commun. 2022 Oct;29:100973. doi: 10.1016/j.conctc.2022.100973. Epub 2022 Aug 17. Contemp Clin Trials Commun. 2022. PMID: 35989898 Free PMC article.
Effectiveness of Iodophor vs Chlorhexidine Solutions for Surgical Site Infections and Unplanned Reoperations for Patients Who Underwent Fracture Repair: The PREP-IT Master Protocol.
Program of Randomized Trials to Evaluate Pre-operative Antiseptic Skin Solutions in Orthopaedic Trauma (PREP-IT) Investigators; Slobogean GP, Sprague S, Wells J, Bhandari M, Rojas A, Garibaldi A, Wood A, Howe A, Harris AD, Petrisor BA, Mullins DC, Pogorzelski D, Marvel D, Heels-Ansdell D, Mossuto F, Grissom F, Del Fabbro G, Guyatt GH, Della Rocca GJ, Demyanovich HK, Gitajn IL, Palmer J, D'Alleyrand JC, Friedrich J, Rivera J, Hebden J, Rudnicki J, Fowler J, Jeray KJ, Thabane L, Marchand L, O'Hara LM, Joshi MG, Talbot M, Camara M, Szasz OP, O'Hara NN, McKay P, Devereaux PJ, O'Toole RV, Zura R, Morshed S, Dodds S, Li S, Tanner SL, Scott T, Nguyen U. Program of Randomized Trials to Evaluate Pre-operative Antiseptic Skin Solutions in Orthopaedic Trauma (PREP-IT) Investigators, et al. JAMA Netw Open. 2020 Apr 1;3(4):e202215. doi: 10.1001/jamanetworkopen.2020.2215. JAMA Netw Open. 2020. PMID: 32259266 Free PMC article. Clinical Trial.
Low Adherence to Recommended Guidelines for Open Fracture Antibiotic Prophylaxis.
Lin CA, O'Hara NN, Sprague S, O'Toole RV, Joshi M, Harris AD, Warner SJ, Johal H, Natoli RM, Hagen JE, Jeray KJ, Fowler JT, Phelps KD, Pilson HT, Gitajn IL, Bhandari M, Slobogean GP; the PREP-IT Investigators. Lin CA, et al. J Bone Joint Surg Am. 2021 Apr 7;103(7):609-617. doi: 10.2106/JBJS.20.01229. J Bone Joint Surg Am. 2021. PMID: 33411466
Pragmatic randomized trial evaluating pre-operative aqueous antiseptic skin solution in open fractures (Aqueous-PREP): the feasibility of a cluster randomized crossover study.
Sprague S, Guyatt P, Bzovsky S, Nguyen U, Bhandari M, Thabane L, Petrisor B, Johal HS, Leonard J, Dodds S, Mossuto F, O'Toole RV, Howe A, Demyanovich HK, Camara M, O'Hara NN, Slobogean GP; PREP-IT Investigators. Sprague S, et al. Pilot Feasibility Stud. 2021 Mar 1;7(1):61. doi: 10.1186/s40814-021-00800-8. Pilot Feasibility Stud. 2021. PMID: 33648577 Free PMC article.
Managing work flow in high enrolling trials: The development and implementation of a sampling strategy in the PREPARE trial.
Pogorzelski D, Nguyen U, McKay P, Thabane L, Camara M, Ramsey L, Seymour R, Goodman JB, McGee S, Fraifogl J, Hudgins A, Tanner SL, Bhandari M, Slobogean GP, Sprague S; 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. Pogorzelski D, et al. Among authors: fraifogl j. Contemp Clin Trials Commun. 2021 Jan 23;21:100730. doi: 10.1016/j.conctc.2021.100730. eCollection 2021 Mar. Contemp Clin Trials Commun. 2021. PMID: 33605946 Free PMC article.
Patient and stakeholder engagement learnings: PREP-IT as a case study.
Medeiros M, Love TR, Slobogean GP, Sprague S, Perfetto EM, O'Hara NN, Mullins CD; PREP-IT Investigators:. Medeiros M, et al. J Comp Eff Res. 2021 Apr;10(6):439-442. doi: 10.2217/cer-2020-0266. Epub 2021 Mar 24. J Comp Eff Res. 2021. PMID: 33759556 Free article. No abstract available.
Outcomes in patients with gunshot wounds to the brain.
Robinson LA, Turco LM, Robinson B, Corsa JG, Mount M, Hamrick AV, Berne J, Mederos DR, McNickle AG, Chestovich PJ, Weinberger J, Grigorian A, Nahmias J, Lee JK, Chow KL, Olson EJ, Pascual JL, Solomon R, Pigneri DA, Ladhani HA, Fraifogl J, Claridge J, Curry T, Costantini TW, Kongwibulwut M, Kaafarani H, San Roman J, Schreiber C, Goldenberg-Sandau A, Hu P, Bosarge P, Uhlich R, Lunardi N, Usmani F, Sakran JV, Babcock JM, Quispe JC, Lottenberg L, Cabral D, Chang G, Gulmatico J, Parks JJ, Rattan R, Massetti J, Gurney O, Bruns B, Smith AA, Guidry C, Kutcher ME, Logan MS, Kincaid MY, Spalding C, Noorbaksh M, Philp FH, Cragun B, Winfield RD. Robinson LA, et al. Among authors: fraifogl j. Trauma Surg Acute Care Open. 2019 Nov 17;4(1):e000351. doi: 10.1136/tsaco-2019-000351. eCollection 2019. Trauma Surg Acute Care Open. 2019. PMID: 31799416 Free PMC article.
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