What it does
The baseline table of a randomized controlled trial reports samples drawn from a single pre-treatment population, so the arm-to-arm variation of its means and counts is statistically predictable. Fabricated baseline data are routinely too similar across arms — the signature by which John Carlisle unmasked the Fujii fraud [1]. IntegrityAnalysis replays a submitted or published trial’s baseline table many thousands of times by Monte Carlo simulation, reproducing the printed rounding exactly, and reports one probability per trial: the chance that random allocation would produce baseline data at least as homogeneous as those reported [2, 3]. A small value is a screening signal that warrants scrutiny of the original data — it is never, by itself, a verdict of misconduct.
Using it
- Upload the article PDF — the baseline table is extracted automatically — or a spreadsheet, or several files at once, or type the table directly into the editable grid.
- Validation reports problems by coloring the cells of the grid; fix them in place and revalidate.
- Results give a one-sided p value per baseline variable and per trial, with the Monte Carlo precision made explicit.
- A journal-style reconstruction of the baseline table can be downloaded for side-by-side comparison against the manuscript.
- The engine reproduces Carlisle’s published 2017 analysis of 5,087 trials with r = 0.991 [3].
The user guide documents the method, the input formats, and the statistics in full.
References
- Carlisle JB. The analysis of 168 randomised controlled trials to test data integrity. Anaesthesia. 2012;67:521–537. doi:10.1111/j.1365-2044.2012.07128.x
- Carlisle JB, Dexter F, Pandit JJ, Shafer SL, Yentis SM. Calculating the probability of random sampling for continuous variables in submitted or published randomised controlled trials. Anaesthesia. 2015;70:848–858. doi:10.1111/anae.13126
- Carlisle JB. Data fabrication and other reasons for non-random sampling in 5087 randomised, controlled trials in anaesthetic and general medical journals. Anaesthesia. 2017;72:944–952. doi:10.1111/anae.13938