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Table 1 Summary of results by analysis model, trajectory type, treatment effect type and whether proposed trial is the same length as the observational study

From: How important is the linearity assumption in a sample size calculation for a randomised controlled trial where treatment is anticipated to affect a rate of change?

Analysis model

Linear or non-linear trajectory in DGM

Proportional or non-proportional treatment effect in DGM

Observational study length relative to trial length

Impact on power

Notes

Random slopes model

Linear

Proportional

Same

None noticeable

Assumptions of sample size calculation are met

Different

None noticeable

Non-linear

Proportional

Same

None noticeable

 

Different

Can differ from nominal

Close to nominal when residual error is large relative to between-person variance, but can differ from nominal when residual error is small. Power can be higher or lower than nominal

Non-linear

Non-proportional

Same

Can be very far from nominal

Differing power is partially due to incorrect target treatment effect used in sample size calculation. Power can be higher or lower than nominal

Different

Can be very far from nominal

Free trajectories, free covariancea

Linear

Proportional

Same

Power loss

Power loss is greater when residual error is large relative to between-person variance

Different

Power loss

Non-linear

Proportional

Same

Power loss

Power loss is greater when within-person error is large relative to between-person error

Different

Can differ from nominal

Power can be higher or lower than nominal

Non-linear

Non-proportional

Same

Some power loss

 

Different

Can be far from nominal

Differing power is partially due to incorrect target treatment effect used in sample size calculation. Power can be higher or lower than nominal

  1. aSample size for the free trajectories, free covariance model is calculated under the assumption of a random slopes model
  2. DGM Data generating mechanism