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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. Among authors: pogorzelski d. 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.
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. Among authors: pogorzelski d, d alleyrand jc. 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.
Cluster identification, selection, and description in cluster randomized crossover trials: the PREP-IT trials.
Sprague S, Scott T, Dodds S, Pogorzelski D, McKay P, Harris AD, Wood A, Thabane L, Bhandari M, Mehta S, Gaski G, Boulton C, Marcano-Fernández F, Guerra-Farfán E, Hebden J, O'Hara LM, Slobogean GP; PREP-IT Investigators. Sprague S, et al. Among authors: pogorzelski d. Trials. 2020 Aug 12;21(1):712. doi: 10.1186/s13063-020-04611-9. Trials. 2020. PMID: 32787892 Free PMC article.
Correction to: Cluster identification, selection, and description in Cluster randomized crossover trials: the PREP-IT trials.
Sprague S, Scott T, Dodds S, Pogorzelski D, McKay P, Harris AD, Wood A, Thabane L, Bhandari M, Mehta S, Gaski G, Boulton C, Marcano-Fernández F, Guerra-Farfán E, Hebden J, O'Hara LM, Slobogean GP; PREP-IT Investigators. Sprague S, et al. Among authors: pogorzelski d. Trials. 2020 Sep 30;21(1):821. doi: 10.1186/s13063-020-04767-4. Trials. 2020. PMID: 32998779 Free PMC article.
What's Important: Patient Engagement in Research.
Hale D, Marvel D, Wells J; PREP-IT Investigators. Hale D, et al. J Bone Joint Surg Am. 2020 Oct 21;102(20):1836-1838. doi: 10.2106/JBJS.19.00625. J Bone Joint Surg Am. 2020. PMID: 33086354 No abstract available.
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. 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.
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.
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.
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. 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.
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