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J Clin Epidemiol. 2011 Sep;64(9):1023-33. doi: 10.1016/j.jclinepi.2010.12.007. Epub 2011 Mar 25.

Outcomes assessment in the SPRINT multicenter tibial fracture trial: Adjudication committee size has trivial effect on trial results.

Collaborators (300)

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, 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 H, Stephen DJ, Axelrod TS, Yee AJ, Richards RR, Finkelstein J, Holtby RM, Cameron H, Cameron J, Gofton W, Murnaghan J, Schatztker J, Bulmer B, Conlan L, Laflamme Y, Berry G, Beaumont P, Ranger P, Laflamme GH, Jodoin A, Renaud E, Gagnon S, Maurais G, Malo M, Fernandes J, Latendresse K, Poirier MF, Daigneault G, Schemitsch EH, McKee MM, Waddell JP, Bogoch ER, Daniels TR, McBroom RR, Richards 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, Desmond Brown T, Pacicca D, Sledge JB 3rd, Foster TE, Voloshin I, Bolton J, Carlisle H, Shaughnessy L, Ombremsky WT, LeCroy C, 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, Hansley G, 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, Health H, 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 B, Swiontkowski MF, Agel J, Garaghty MJ, Salzman JG, Schutte CA, Tastad LT, Vang S, Seligson D, Roberts CS, Malkani AL, Sanders L, Gregory SA, Dyer C, Heinsen J, Smith L, Madanagopal S, 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 J, 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 J, Moon BS, Tanner SL, Powell JN, Buckley RE, Elves L, Connolly S, Abraham EP, Eastwood D, 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, Hsin C, Lin 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.

Abstract

OBJECTIVE:

To evaluate how the size of an outcome adjudication committee, and the potential for dominance among its members, potentially impacts a trial's results.

STUDY DESIGN AND SETTING:

We conducted a retrospective analysis of data from the six-member adjudication committee in the Study to Prospectively Evaluate Reamed Intramedullary Nails in Patients with Tibial Fractures (SPRINT) Trial. We modeled the adjudication process, predicted the results and costs if smaller committees had been used, and tested for the presence of a dominant adjudicator.

RESULTS:

Use of smaller committee sizes (one to five members) would have had little impact on the final study results, although one analysis suggested that the benefit in reduction of reoperations with reamed nails in closed tibial fractures would have lost significance if committee sizes of three or less were used. We identified a significant difference between adjudicators in the number of times their original minority decisions became the final consensus decision (χ(2)=9.67, P=0.046), suggesting that dominant adjudicators were present. However, their impact on the final study results was trivial.

CONCLUSION:

Reducing the number of adjudicators from six to four would have led to little change in the final SPRINT study results irrespective of the significance of the original trial results, demonstrating the potential for savings in trial resources.

PMID:
21439784
DOI:
10.1016/j.jclinepi.2010.12.007
[Indexed for MEDLINE]

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