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J Orthop Trauma. 2016 Mar;30(3):156-61.

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

Collaborators (288)

Bhandari M, Guyatt G, Guyatt G, Bhandari M, Sanders DW, Schemitsch EH, Swiontkowski M, Tornetta P 3rd, Walter S, Guyatt G, Bhandari M, Sanders DW, Schemitsch EH, Swiontkowski M, Tornetta P 3rd, Walter S, 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, Agel J, Sprague S, Poolman R, Bhandari M, Sanders DW, 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 DJ, Axelrod TS, Yee AJ, 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 GH, Gagnon S, Malo M, Fernandes J, Poirier MF, Schemitsch EH, 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, Tornetta P 3rd, Creevy WR, Stein AB, Bono CT, Einhorn TA, Brown TD, Pacicca D, Sledge JB 3rd, Foster TE, Voloshin I, Bolton J, Carlisle H, Shaughnessy L, Obremskey WT, LeCroy CM, Meinberg EG, Messer TM, Craig WL 3rd, Dirschl DR, Caudle R, Harris T, Elhert K, Hage W, Jones R, Piedrahita L, Schricker PO, Driver R, Godwin J, Obremskey WT, 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 JT, Hussain T, Rajaratnam K, Petrisor B, Bhandari M, Drew B, Bednar DA, Kwok DC, Pettit S, Hancock J, Sidorkewicz N, Cole PA, Smith JJ, Brown GA, 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 WJ, Puckett TA, Pasque CB, Tompkins JF 2nd, 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 3rd, Matityahu A, Coughlin RR, Kandemir U, McClellan RT, Lin CH, 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.

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.

PMID:
27326429
[Indexed for MEDLINE]

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