Does Participation in a Randomized Clinical Trial Change Outcomes? An Evaluation of Patients Not Enrolled in the SPRINT Trial

Item request has been placed! ×
Item request cannot be made. ×
loading   Processing Request
  • Source:
    Journal of orthopaedic trauma 2016 30 3, 156 (156-61) Published by: Lippincott Williams and Wilkins United States
  • Additional Information
    • Author(s):
      Lin CA, Bhandari M, Guyatt G, Walter SD, Schemitsch EH, Swiontkowski M, Sanders D, Tornetta P, Sanders DW, Sprague S, Heels-Ansdell D, Buckingham L, Leece P, Viveiros H, Mignott T, Ansell N, Sidorkewicz N, Agel J, Bombardier C, Berlin JA, Bosse M, Browner B, Gillespie B, Jones A, O'Brien P, Poolman R, Macleod MD, Carey T, Leitch K, Bailey S, Gurr K, Konito K, Bartha C, Low I, MacBean LV, Ramu M, Reiber S, Strapp R, Tieszer C, Kreder HJ, Stephen DJG, Axelrod TS, Yee AJM, Richards RR, Finkelstein J, Gofton W, Murnaghan J, Schatztker J, Ford M, Bulmer B, Conlan L, Laflamme GY, Berry G, Beaumont P, Ranger P, Laflamme G-H, Gagnon S, Malo M, Fernandes J, Poirier M-F, McKee MD, Waddell JP, Bogoch ER, Daniels TR, McBroom RR, Vicente MR, Storey W, Wild LM, McCormack R, Perey B, Goetz TJ, Pate G, Penner MJ, Panagiotopoulos K, Pirani S, Dommisse IG, Loomer RL, Stone T, Moon K, Zomar M, Webb LX, Teasdall RD, Birkedal JP, Martin DF, Ruch DS, Kilgus DJ, Pollock DC, Harris MB, Wiesler ER, Ward WG, Shilt JS, Koman AL, Poehling GG, Kulp B, Creevy WR, Stein AB, Bono CT, Einhorn TA, Brown TD, Pacicca D, Sledge JB, Foster TE, Voloshin I, Bolton J, Carlisle H, Shaughnessy L, Obremskey WT, LeCroy CM, Meinberg EG, Messer TM, Craig WL, Dirschl DR, Caudle R, Harris T, Elhert K, Hage W, Jones R, Piedrahita L, Schricker PO, Driver R, Godwin J, Kregor PJ, Tennent G, Truchan LM, Sciadini M, Shuler FD, Driver RE, Nading MA, Neiderstadt J, Vap AR, Vallier HA, Patterson BM, Wilber JH, Wilber RG, Sontich JK, Moore TA, Brady D, Cooperman DR, Davis JA, Cureton BA, Mandel S, Orr RD, Sadler JTS, Hussain T, Rajaratnam K, Petrisor B, Drew B, Bednar DA, Kwok DCH, Pettit S, Hancock J, Cole PA, Smith JJ, Lange TA, Stark JG, Levy BA, Swiontkowski MF, Garaghty MJ, Salzman JG, Schutte CA, Tastad L, Vang S, Seligson D, Roberts CS, Malkani AL, Sanders L, Dyer C, Heinsen J, Smith L, Madanagopal S, Frantz-Bush L, Coupe KJ, Tucker JJ, Criswell AR, Buckle R, Rechter AJ, Sheth DS, Urquart B, Trotscher T, Anders MJ, Kowalski JM, Fineberg MS, Bone LB, Phillips MJ, Rohrbacher B, Stegemann P, Mihalko WM, Buyea C, Augustine SJ, Jackson WT, Solis G, Ero SU, Segina DN, Berrey HB, Agnew SG, Fitzpatrick M, Campbell LC, Derting L, McAdams J, Goslings JC, Ponsen KJ, Luitse J, Kloen P, Joosse P, Winkelhagen J, Duivenvoorden R, Teague DC, Davey J, Sullivan JA, Ertl WJJ, Puckett TA, Pasque CB, Tompkins Ii JF, Gruel CR, Kammerlocher P, Lehman TP, Puffinbarger WR, Carl KL, Weber DW, Jomha NM, Goplen GR, Masson E, Beaupre LA, Greaves KE, Schaump LN, Jeray KJ, Goetz DR, Westberry DE, Broderick JS, Moon BS, Tanner SL, Powell JN, Buckley RE, Elves L, Connolly S, Abraham EP, Steele T, Ellis T, Herzberg A, Brown GA, Crawford DE, Hart R, Hayden J, Orfaly RM, Vigland T, Vivekaraj M, Bundy GL, Miclau T, Matityahu A, Coughlin RR, Kandemir U, McClellan RT, Lin CH-H, Karges D, Cramer K, Watson JT, Moed B, Scott B, Beck DJ, Orth C, Puskas D, Clark R, Jones J, Egol KA, Paksima N, France M, Wai EK, Johnson G, Wilkinson R, Gruszczynski AT, Vexler L
    • Contact Information:
      C.A. Lin, Hennepin County Medical Center, 701 Park Avenue, G.200, Minneapolis, MN 55415, United States. E-mail: Carolalin.md@outlook.com
    • Language:
      English
    • Publication Type:
      Journal: Conference Paper
    • Record Status:
      This record is this issue.
    • Abstract:
      Objectives: To determine the extent to which knowledge from clinical trial protocols is transferred to nonparticipating patients. Design: Retrospective review of prospectively collected data from a large clinical trial. Setting: Six level-1 international trauma centers. Methods: We compared rates and timing of reoperation in a subset of patients enrolled in the Study to Prospectively evaluate Reamed Intramedullary Nails in Patients with Tibial Fractures (SPRINT) to concurrent patients who were eligible but not enrolled. This was a retrospective review of prospectively collected trial data. The records of 6 of the original SPRINT centers were searched for non-SPRINT patients who underwent intramedullary nailing of a closed tibial fracture. The rate and timing of reoperation were compared. A P < 0.05 was considered significant. Results: One hundred fourteen non-SPRINT patients were compared with 328 patients enrolled in SPRINT from those same sites. There were 7 reoperations (6.1%) in non-SPRINT patients versus 18 (5.2%) in SPRINT patients [odds ratio (OR) 1.19, 95% confidence interval (CI) 0.41 to 3.13; P 0.811]. There was no difference in the time to reoperation between the SPRINT and non-SPRINT patients (6.2 vs. 6.8 months, 95% CI of the difference -3.8 to 2.6; P 0.685) or in the proportion of patients who underwent reoperation before 6 months (29% vs. 43%; OR 1.75; 95% CI 0.18 to 15.41; P 0.647). Conclusions: Patients not enrolled in SPRINT had similarly low rates of reoperation for nonunion, and the average time to reoperation for both groups was longer than 6 months. A 6-month waiting period may have allowed slow-to-heal fractures adequate time to heal, thereby reducing the rate of diagnosis of nonunion. As such, this waiting period could contribute to lower-than-expected reoperation rates for nonunion. It is possible that clinical trials may beneficially influence the care of nonenrolled patients.
    • EMBASE keywords:
      clinical protocol; cohort analysis; compartment syndrome; conference paper; controlled study; emergency health service; fasciotomy; fracture healing; fracture nonunion/su [Surgery]; human; *intramedullary nailing; major clinical study; outcome assessment; postoperative infection; priority journal; randomized controlled trial (topic); *reoperation; research subject; retrospective study; *tibia fracture/su [Surgery]; tibia shaft fracture/su [Surgery]
    • Accession Number:
      20160167686
    • Source:
      This document should be cited as: Lin CA Bhandari M Guyatt G Walter SD Schemitsch EH Swiontkowski M Sanders D Tornetta P Sanders DW Sprague S Heels-Ansdell D Buckingham L Leece P Viveiros H Mignott T Ansell N Sidorkewicz N Agel J Bombardier C Berlin JA Bosse M Browner B Gillespie B Jones A O'Brien P Poolman R Macleod MD Carey T Leitch K Bailey S Gurr K Konito K Bartha C Low I MacBean LV Ramu M Reiber S Strapp R Tieszer C Kreder HJ Stephen DJG Axelrod TS Yee AJM Richards RR Finkelstein J Gofton W Murnaghan J Schatztker J Ford M Bulmer B Conlan L Laflamme GY Berry G Beaumont P Ranger P Laflamme G-H Gagnon S Malo M Fernandes J Poirier M-F McKee MD Waddell JP Bogoch ER Daniels TR McBroom RR Vicente MR Storey W Wild LM McCormack R Perey B Goetz TJ Pate G Penner MJ Panagiotopoulos K Pirani S Dommisse IG Loomer RL Stone T Moon K Zomar M Webb LX Teasdall RD Birkedal JP Martin DF Ruch DS Kilgus DJ Pollock DC Harris MB Wiesler ER Ward WG Shilt JS Koman AL Poehling GG Kulp B Creevy WR Stein AB Bono CT Einhorn TA Brown TD Pacicca D Sledge JB Foster TE Voloshin I Bolton J Carlisle H Shaughnessy L Obremskey WT LeCroy CM Meinberg EG Messer TM Craig WL Dirschl DR Caudle R Harris T Elhert K Hage W Jones R Piedrahita L Schricker PO Driver R Godwin J Kregor PJ Tennent G Truchan LM Sciadini M Shuler FD Driver RE Nading MA Neiderstadt J Vap AR Vallier HA Patterson BM Wilber JH Wilber RG Sontich JK Moore TA Brady D Cooperman DR Davis JA Cureton BA Mandel S Orr RD Sadler JTS Hussain T Rajaratnam K Petrisor B Drew B Bednar DA Kwok DCH Pettit S Hancock J Cole PA Smith JJ Lange TA Stark JG Levy BA Swiontkowski MF Garaghty MJ Salzman JG Schutte CA Tastad L Vang S Seligson D Roberts CS Malkani AL Sanders L Dyer C Heinsen J Smith L Madanagopal S Frantz-Bush L Coupe KJ Tucker JJ Criswell AR Buckle R Rechter AJ Sheth DS Urquart B Trotscher T Anders MJ Kowalski JM Fineberg MS Bone LB Phillips MJ Rohrbacher B Stegemann P Mihalko WM Buyea C Augustine SJ Jackson WT Solis G Ero SU Segina DN Berrey HB Agnew SG Fitzpatrick M Campbell LC Derting L McAdams J Goslings JC Ponsen KJ Luitse J Kloen P Joosse P Winkelhagen J Duivenvoorden R Teague DC Davey J Sullivan JA Ertl WJJ Puckett TA Pasque CB Tompkins Ii JF Gruel CR Kammerlocher P Lehman TP Puffinbarger WR Carl KL Weber DW Jomha NM Goplen GR Masson E Beaupre LA Greaves KE Schaump LN Jeray KJ Goetz DR Westberry DE Broderick JS Moon BS Tanner SL Powell JN Buckley RE Elves L Connolly S Abraham EP Steele T Ellis T Herzberg A Brown GA Crawford DE Hart R Hayden J Orfaly RM Vigland T Vivekaraj M Bundy GL Miclau T Matityahu A Coughlin RR Kandemir U McClellan RT Lin CH-H Karges D Cramer K Watson JT Moed B Scott B Beck DJ Orth C Puskas D Clark R Jones J Egol KA Paksima N France M Wai EK Johnson G Wilkinson R Gruszczynski AT Vexler L. Does Participation in a Randomized Clinical Trial Change Outcomes? An Evaluation of Patients Not Enrolled in the SPRINT Trial 2016 (The Cochrane Controlled Trials Register (CCTR/CENTRAL). DOI: 10.1097/BOT.0000000000000533. Oxford: Update Software. Updated quarterly.
    • Accession Number:
      CN-01171733
  • Citations
    • ABNT:
      LIN CA et al. Does Participation in a Randomized Clinical Trial Change Outcomes? An Evaluation of Patients Not Enrolled in the SPRINT Trial. Journal of orthopaedic trauma, [s. l.], v. 30, n. 3, p. 156–161, 2016. DOI 10.1097/BOT.0000000000000533. Disponível em: http://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=cgh&AN=CN-01171733. Acesso em: 25 set. 2020.
    • AMA:
      Lin CA, Bhandari M, Guyatt G, et al. Does Participation in a Randomized Clinical Trial Change Outcomes? An Evaluation of Patients Not Enrolled in the SPRINT Trial. Journal of orthopaedic trauma. 2016;30(3):156-161. doi:10.1097/BOT.0000000000000533
    • APA:
      Lin CA, Bhandari M, Guyatt G, Walter SD, Schemitsch EH, Swiontkowski M, Sanders D, Tornetta P, Sanders DW, Sprague S, Heels-Ansdell D, Buckingham L, Leece P, Viveiros H, Mignott T, Ansell N, Sidorkewicz N, Agel J, Bombardier C, … Vexler L. (2016). Does Participation in a Randomized Clinical Trial Change Outcomes? An Evaluation of Patients Not Enrolled in the SPRINT Trial. Journal of Orthopaedic Trauma, 30(3), 156–161. https://doi.org/10.1097/BOT.0000000000000533
    • Chicago/Turabian: Author-Date:
      Lin CA, Bhandari M, Guyatt G, Walter SD, Schemitsch EH, Swiontkowski M, Sanders D, et al. 2016. “Does Participation in a Randomized Clinical Trial Change Outcomes? An Evaluation of Patients Not Enrolled in the SPRINT Trial.” Journal of Orthopaedic Trauma 30 (3): 156–61. doi:10.1097/BOT.0000000000000533.
    • Harvard:
      Lin CA et al. (2016) ‘Does Participation in a Randomized Clinical Trial Change Outcomes? An Evaluation of Patients Not Enrolled in the SPRINT Trial’, Journal of orthopaedic trauma, 30(3), pp. 156–161. doi: 10.1097/BOT.0000000000000533.
    • Harvard: Australian:
      Lin CA, Bhandari M, Guyatt G, Walter SD, Schemitsch EH, Swiontkowski M, Sanders D, Tornetta P, Sanders DW, Sprague S, Heels-Ansdell D, Buckingham L, Leece P, Viveiros H, Mignott T, Ansell N, Sidorkewicz N, Agel J, Bombardier C, Berlin JA, Bosse M, Browner B, Gillespie B, Jones A, O’Brien P, Poolman R, Macleod MD, Carey T, Leitch K, Bailey S, Gurr K, Konito K, Bartha C, Low I, MacBean LV, Ramu M, Reiber S, Strapp R, Tieszer C, Kreder HJ, Stephen DJG, Axelrod TS, Yee AJM, Richards RR, Finkelstein J, Gofton W, Murnaghan J, Schatztker J, Ford M, Bulmer B, Conlan L, Laflamme GY, Berry G, Beaumont P, Ranger P, Laflamme G-H, Gagnon S, Malo M, Fernandes J, Poirier M-F, McKee MD, Waddell JP, Bogoch ER, Daniels TR, McBroom RR, Vicente MR, Storey W, Wild LM, McCormack R, Perey B, Goetz TJ, Pate G, Penner MJ, Panagiotopoulos K, Pirani S, Dommisse IG, Loomer RL, Stone T, Moon K, Zomar M, Webb LX, Teasdall RD, Birkedal JP, Martin DF, Ruch DS, Kilgus DJ, Pollock DC, Harris MB, Wiesler ER, Ward WG, Shilt JS, Koman AL, Poehling GG, Kulp B, Creevy WR, Stein AB, Bono CT, Einhorn TA, Brown TD, et al. 2016, ‘Does Participation in a Randomized Clinical Trial Change Outcomes? An Evaluation of Patients Not Enrolled in the SPRINT Trial’, Journal of orthopaedic trauma, vol. 30, no. 3, pp. 156–161, viewed 25 September 2020, .
    • MLA:
      Lin CA, et al. “Does Participation in a Randomized Clinical Trial Change Outcomes? An Evaluation of Patients Not Enrolled in the SPRINT Trial.” Journal of Orthopaedic Trauma, vol. 30, no. 3, Jan. 2016, pp. 156–161. EBSCOhost, doi:10.1097/BOT.0000000000000533.
    • Chicago/Turabian: Humanities:
      Lin CA, Bhandari M, Guyatt G, Walter SD, Schemitsch EH, Swiontkowski M, Sanders D, et al. “Does Participation in a Randomized Clinical Trial Change Outcomes? An Evaluation of Patients Not Enrolled in the SPRINT Trial.” Journal of Orthopaedic Trauma 30, no. 3 (January 1, 2016): 156–61. doi:10.1097/BOT.0000000000000533.
    • Vancouver/ICMJE:
      Lin CA, Bhandari M, Guyatt G, Walter SD, Schemitsch EH, Swiontkowski M, et al. Does Participation in a Randomized Clinical Trial Change Outcomes? An Evaluation of Patients Not Enrolled in the SPRINT Trial. Journal of orthopaedic trauma [Internet]. 2016 Jan 1 [cited 2020 Sep 25];30(3):156–61. Available from: http://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=cgh&AN=CN-01171733