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Protocol Generator · ITS

Interrupted Time Series protocol

In plain terms. Something changed on a known date. Take the outcome as it was trending before that date, draw that trend forward as "what would have happened anyway", and ask how far the outcome afterwards departs from it — both as an immediate jump and as a change of direction.

The two things a segmented regression separates, and why it matters

The outcome is aggregated into equal time intervals and regressed on three terms: time (the pre-intervention slope), an interruption indicator (1 from the first affected period onward), and time-since-interruption (0 until the interruption, then counting up). Their coefficients are the baseline trend, the change in level — the immediate step at the interruption — and the change in slope — how the trend itself bends afterwards. They answer different questions and can point in opposite directions: a policy can cause a sharp one-off drop that then drifts back up (level change down, slope change up), and reporting only one of the two would describe it wrongly (Wagner 2002; Lopez Bernal 2017).

Two things routinely break it. Seasonality: if the outcome has an annual cycle and the interruption falls at a particular point in that cycle, the cycle is read as a step or a bend. Autocorrelation: adjacent time points resemble each other, which does not bias the coefficients but makes the standard errors too small and the confidence intervals too narrow. Neither is optional to consider.

Why a control series strengthens the claim. An uncontrolled ITS attributes every departure from the extrapolated pre-trend to the intervention — including anything else that happened at the same time, and any secular change that was already bending. A comparison series that shares the secular environment but is not exposed to the intervention lets you difference those out: the estimate becomes the difference in level and slope changes, and a co-intervention affecting both series cancels (Lopez Bernal 2018).

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1 · Identity

📚 Databases / sites (fills “Data source(s)”)

Taiwan

South Korea

Japan

Hong Kong

Australia

Finland

United Kingdom

Netherlands

United States

2 · Question
Population
Outcome (a rate, count, or level over time)
3 · Time series & interruption
4 · Model specification

If you intend to run this in RWE Studio. Every option here is a legitimate protocol choice — you may well execute the analysis in R, SAS or Stata. But the Studio's in-browser ITS does not implement all of them, so pick deliberately rather than being surprised later. It runs: the segmented Poisson / negative-binomial and linear models, calendar-period and harmonic seasonality, a control series with group-by-segment interactions, and Newey–West (HAC) standard errors. It does not implement Prais–Winsten or ARIMA errors; it has no way to exclude a transition / phase-in period around the interruption; and it reports the difference from the counterfactual at the end of follow-up rather than at a time point you nominate.

5 · Subgroups & sensitivity
Subgroup analyses (tick to perform)
Sensitivity analyses (tick to perform)
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Consistency checks · ITS 防呆

Study design diagram