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

the SPRINT Investigators

Research output: Contribution to journalArticle

1 Citation (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)156-161
Number of pages6
JournalJournal of Orthopaedic Trauma
Volume30
Issue number3
DOIs
StatePublished - Mar 1 2016

Fingerprint

Randomized Controlled Trials
Reoperation
Tibial Fractures
Clinical Trials
Confidence Intervals
Clinical Protocols
Odds Ratio
Closed Fractures
Intramedullary Fracture Fixation
Trauma Centers
Nails
Patient Care

Keywords

  • nonunion
  • reamed
  • tibia fracture
  • unreamed

ASJC Scopus subject areas

  • Surgery
  • Orthopedics and Sports Medicine

Cite this

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

In: Journal of Orthopaedic Trauma, Vol. 30, No. 3, 01.03.2016, p. 156-161.

Research output: Contribution to journalArticle

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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.",
keywords = "nonunion, reamed, tibia fracture, unreamed",
author = "{the SPRINT Investigators} and Lin, {Carol Alice} and Mohit Bhandari and Gordon Guyatt and Walter, {Stephen D.} and Schemitsch, {Emil H.} and Marc Swiontkowski and David Sanders and Paul Tornetta and Sanders, {David W.} and Sheila Sprague and Diane Heels-Ansdell and Lisa Buckingham and Pamela Leece and Helena Viveiros and Tashay Mignott and Natalie Ansell and Natalie Sidorkewicz and Julie Agel and Claire Bombardier and Berlin, {Jesse A.} and Michael Bosse and Bruce Browner and Brenda Gillespie and Alan Jones and Peter O'Brien and Rudolf Poolman and Macleod, {Mark D.} and Timothy Carey and Kellie Leitch and Stuart Bailey and Kevin Gurr and Ken Konito and Charlene Bartha and Isolina Low and MacBean, {Leila V.} and Mala Ramu and Susan Reiber and Ruth Strapp and Christina Tieszer and Kreder, {Hans J.} and Stephen, {David J G} and Axelrod, {Terry S.} and Yee, {Albert J M} and Richards, {Robin R.} and Joel Finkelstein and Wade Gofton and Dennis Crawford and Robert Hart and James Hayden and Robert Orfaly",
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T1 - Does Participation in a Randomized Clinical Trial Change Outcomes? An Evaluation of Patients Not Enrolled in the SPRINT Trial

AU - the SPRINT Investigators

AU - Lin, Carol Alice

AU - Bhandari, Mohit

AU - Guyatt, Gordon

AU - Walter, Stephen D.

AU - Schemitsch, Emil H.

AU - Swiontkowski, Marc

AU - Sanders, David

AU - Tornetta, Paul

AU - Sanders, David W.

AU - Sprague, Sheila

AU - Heels-Ansdell, Diane

AU - Buckingham, Lisa

AU - Leece, Pamela

AU - Viveiros, Helena

AU - Mignott, Tashay

AU - Ansell, Natalie

AU - Sidorkewicz, Natalie

AU - Agel, Julie

AU - Bombardier, Claire

AU - Berlin, Jesse A.

AU - Bosse, Michael

AU - Browner, Bruce

AU - Gillespie, Brenda

AU - Jones, Alan

AU - O'Brien, Peter

AU - Poolman, Rudolf

AU - Macleod, Mark D.

AU - Carey, Timothy

AU - Leitch, Kellie

AU - Bailey, Stuart

AU - Gurr, Kevin

AU - Konito, Ken

AU - Bartha, Charlene

AU - Low, Isolina

AU - MacBean, Leila V.

AU - Ramu, Mala

AU - Reiber, Susan

AU - Strapp, Ruth

AU - Tieszer, Christina

AU - Kreder, Hans J.

AU - Stephen, David J G

AU - Axelrod, Terry S.

AU - Yee, Albert J M

AU - Richards, Robin R.

AU - Finkelstein, Joel

AU - Gofton, Wade

AU - Crawford, Dennis

AU - Hart, Robert

AU - Hayden, James

AU - Orfaly, Robert

PY - 2016/3/1

Y1 - 2016/3/1

N2 - 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.

AB - 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.

KW - nonunion

KW - reamed

KW - tibia fracture

KW - unreamed

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