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Table 4 Numbers of participants providing outcome data at 3, 6 and 12 months, information (\(\text {I}=1/\text {var}(\beta _{s})\)) and test statistic (\(Z=\beta _{s}/\text {sd}(\beta _{s})\)) boundaries for putative START:REACTS trial designs where the sample size is \(N=188\) for [a] an expected fixed rate and [b] a decreasing rate of recruitment

From: Group sequential designs for pragmatic clinical trials with early outcomes: methods and guidance for planning and implementation

[a] Fixed rate

[b] Decreasing rate

Outcome

 

Interim

End

Interim

End

  

1

2

 

1

2

 

12 months

\(N_{3}\)

47.0

65.8

188

47.0

65.8

188

6 months

\(N_{2}\)

94.0

112.8

188

113.5

127.0

188

3 months

\(N_{1}\)

117.5

136.3

188

138.9

149.8

188

Information

I

0.101

0.137

0.326

0.104

0.139

0.326

Information fraction

\(\tau\)

0.309

0.419

1.000

0.318

0.427

1.000

Boundary

lower

-0.706

0.581

1.907

-0.706

0.581

1.910

 

upper

\(\infty\)

3.090

1.907

\(\infty\)

3.090

1.910