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Research ArticleMethodology

Challenges of Prolonged Follow-up and Temporal Imbalance in Pragmatic Trials: Analysis of the ENCOURAGE Trial

Joshua S. Richman, Susan Andreae and Monika M. Safford
The Annals of Family Medicine August 2015, 13 (Suppl 1) S66-S72; DOI: https://doi.org/10.1370/afm.1790
Joshua S. Richman
1Birmingham VA Medical Center, Birmingham, Alabama
2Department of Surgery, School of Medicine, University of Alabama at Birmingham, Birmingham, Alabama
PhD, MD
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  • For correspondence: jrichman@uabmc.edu
Susan Andreae
3Department of Medicine, School of Medicine, University of Alabama at Birmingham, Birmingham, Alabama
MPH
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Monika M. Safford
3Department of Medicine, School of Medicine, University of Alabama at Birmingham, Birmingham, Alabama
MD
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    Figure 1

    The timing of baseline and follow-up data collection in the ENCOURAGE trial displaying temporal differences by study group.

    B. Elapsed time from baseline data collection to follow-up in days, with a vertical line at 15 months, the standard cut-off point for 1-year follow-up. By the 15-month point, 268 participants had been followed up, of whom 51.4% (138) were in the intervention group and 48.5% (130) in the control group. After that point, 92 participants were followed up, of whom 32.6% (30) were in the intervention group and 67.4% (62) were in the control group.

  • Figure 2
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    Figure 2

    The seasonal trend in HbA1c levels in the ENCOURAGE trial.

    Note: The figure reflects all baseline observations reported in calendar days where January 1 is day 1 and December 31 is day 365. The period represented runs from late February to late August.

  • Figure 3
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    Figure 3

    The change in BMI attributable to the intervention over time, by linear model and GAMM.

    Note: The plot shows the adjusted model results for the difference between intervention and control groups (the intervention effect) with 95% confidence regions bounded by thin dashed lines. The heavy dashed line shows no linear effect over time, while the heavy solid line shows the GAMM results, which allow the effect over time to be nonlinear. The GAMM P <.05 and the estimated degrees of freedom (EDF) >1 indicate that the association is significant and that the nonlinearity is important.

    GAMM = generalized additive mixed models.

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The Annals of Family Medicine: 13 (Suppl 1)
The Annals of Family Medicine: 13 (Suppl 1)
Vol. 13, Issue Suppl 1
August 2015
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Challenges of Prolonged Follow-up and Temporal Imbalance in Pragmatic Trials: Analysis of the ENCOURAGE Trial
Joshua S. Richman, Susan Andreae, Monika M. Safford
The Annals of Family Medicine Aug 2015, 13 (Suppl 1) S66-S72; DOI: 10.1370/afm.1790

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Challenges of Prolonged Follow-up and Temporal Imbalance in Pragmatic Trials: Analysis of the ENCOURAGE Trial
Joshua S. Richman, Susan Andreae, Monika M. Safford
The Annals of Family Medicine Aug 2015, 13 (Suppl 1) S66-S72; DOI: 10.1370/afm.1790
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  • statistical data interpretation
  • nonlinear models
  • community-based trials

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