Topic 71 of 76 · Consumer health apps and devices
Patient-Reported Outcomes (PROMs, PREMs, MCID)
PROMs are standardized instruments where patients report their own health status (symptoms, function, quality of life); PREMs capture the care experience. The MCID — minimal clinically important difference — is the smallest score change patients actually perceive as beneficial: the bar any claimed improvement must clear.
Why it matters
PROMs are the primary efficacy currency for digital health: apps rarely move mortality, but they can credibly move validated symptom scores. The instruments that matter are few and standardized — PHQ-9 (depression, 0–27; severity bands at 5/10/15/20), GAD-7 (anxiety, 0–21; bands at 5/10/15), EQ-5D (utility for QALYs) — and regulators, HTA bodies, and payers accept them precisely because they are comparable across products and trials. The MCID is the honesty gate: PHQ-9 MCID ≈ 5 points, GAD-7 ≈ 4, EQ-5D index commonly ~0.03–0.08 — a statistically significant 1.5-point PHQ-9 change on a large sample is real but clinically meaningless, and an evidence reviewer will say so.
The math
PROM scoring: instrument-specific sums (e.g., PHQ-9 = Σ 9 items × 0–3)
MCID estimation:
anchor-based: score change among patients who report "somewhat better"
distribution-based: ≈ 0.5 × SD of baseline scores (rough heuristic)
Response rate framing (for trials and dossiers):
responder = patient improving ≥ MCID (or ≥50% for PHQ-9 convention)
NNT = 1 / (responder rate_treatment − responder rate_control)
— see number-needed-to-treat.md
Worked example
A depression-support app, RCT vs waiting list, 12 weeks:
PHQ-9 change: app −6.2 points, control −2.1 → adjusted difference −4.1
MCID check: 4.1 < 5 → mean difference below MCID; report responders instead:
responders (≥5-point drop): app 48%, control 22% → ARR 26%
NNT = 1/0.26 ≈ 4 — four users treated per additional clinical response
Economic bridge: responders' EQ-5D gain 0.06 sustained 6 months
= 0.03 QALYs; per 1,000 users: 260 extra responders × 0.03 = 7.8 QALYs
≈ £156,000–£234,000 of health value at NICE thresholds
The responder/NNT framing survives review where the sub-MCID mean difference would have been dismissed.
Software engineering connection
PROMs are a data-collection problem software is uniquely placed to solve: in-app instruments get completion rates and longitudinal density paper never achieved, turning routine product telemetry into HTA-grade evidence (EQ-5D is five screens). Engineering rules: use the validated instrument verbatim (rewording invalidates it — licensing applies); schedule measurement by protocol, not engagement convenience (measuring only active users is survivorship bias — see retention); and version-lock instrument data like any schema — a mid-study wording change is data corruption. PREMs map to CSAT/NPS-style instruments, and the same lesson applies: standardized beats homegrown wherever the audience is a payer.
Pitfalls
- Statistical significance below MCID presented as clinical benefit — the field's most common inflation.
- Regression to the mean: users enroll at symptom peaks; single-arm before/after overstates hugely — comparators are non-negotiable.
- Instrument shopping: running PHQ-9, GAD-7, and WHO-5, then reporting whichever moved — pre-register the primary.
- Digital-consent survey pressure: nudging users toward favorable responses corrupts the instrument (and the reviewers know the base rates).
Sources
- MCID estimation review (EQ-5D). https://pmc.ncbi.nlm.nih.gov/articles/PMC10526144/
- PROMs vs PREMs primer. https://www.forcetherapeutics.com/blog/whats-the-difference-between-pros-proms-pro-pms-and-prems
- Kroenke K, et al. PHQ-9 validation literature. https://pubmed.ncbi.nlm.nih.gov/11556941/