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Trial Sequential Analysis Calculator

Check whether a cumulative meta-analysis has enough participants to be conclusive. The tool calculates the required information size and plots the cumulative Z-curve against O'Brien-Fleming-type monitoring boundaries.

FreeNo account neededYour data stays in your browser

Your dataOne row per trial in chronological order: study, events_trt, no_event_trt, events_ctl, no_event_ctl.
Model
0100,000200,000300,000-10-50510Cumulative number of participantsCumulative Z-scoreDARIS = 251,168Cumulative ZMonitoring boundaries (O'Brien-Fleming)Z = ±1.96

Results

Required information size12,894 participantsα = 0.05, power 90%, control risk 0.03, RRR 30%
Diversity-adjusted (DARIS)251,168 participantsD² = 94.9%
Accrued information357,347 participants (142.3% of required)
Cumulative estimateRR 0.49 (95% CI 0.34 to 0.70), Z = -4.00

The cumulative Z-curve crosses a monitoring boundary (or the conventional boundary after the required information size is reached): the evidence may be firm for the anticipated effect.

Boundaries use the Lan-DeMets O'Brien-Fleming-type alpha-spending function at each trial's information fraction (checked against the ldbounds R package). Futility boundaries are not shown. For a registered review, confirm results with the TSA software from the Copenhagen Trial Unit.

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How to Use the Trial Sequential Analysis Calculator

  1. 1

    Paste the trials in date order

    Study name and event counts in each arm.

  2. 2

    Set the assumptions

    Alpha, power, control event proportion and the relative risk reduction you want to detect.

  3. 3

    Read the plot

    Whether the Z-curve crosses a monitoring boundary or the required information size.

Why trial sequential analysis

A meta-analysis updated as new trials appear performs repeated significance tests, which increases the risk of a false-positive result. Trial sequential analysis adjusts for this by comparing the cumulative Z-score with boundaries that are strict early on and relax as information accrues.

The required information size is the number of participants a single adequately powered trial would need, inflated for heterogeneity using the diversity (D²) of the random-effects meta-analysis.

How it is calculated

Sources

Trial Sequential Analysis Calculator: FAQ

What does it mean if the Z-curve crosses the boundary?

The evidence may be firm enough to conclude on the assumed effect, even before the required information size is reached.

Can I use this for a registered review?

Use it to plan and check. For the final analysis, confirm results with the TSA software from the Copenhagen Trial Unit, which also provides futility boundaries.

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