Clinical Trials — AI & Digital Health

Randomized clinical trials in AI- and software-driven care (AI imaging triage, LLM assistants, clinical decision support, assistive robotics), from NEJM · Lancet · Nature Medicine · BMJ (2024–2026)

12findings in 6 areas, across 5 of 6 papers

How the star rating worksShow

Every paper starts at 5★ and loses stars for the concrete problems the review finds — never a vague average, just a running total:

Reporting — 8 dimensionseach dimension that fails (−½★) or is partially met (−¼★)−½ / −¼
Statistics · Integrity · Claimseach serious problem (−1★) · each medium problem−½★
Citationseach retracted or unverifiable reference−½★
Copyeditonly when the manuscript needs a full edit−½★

The rating never drops below 1★, and a demonstrable critical failure (an impossible statistic, a proven ethics violation) caps it at 1★ on its own.

Papers are reviewed on their original full text — any retraction notice is removed before analysis — so the findings reflect the science, not the label.

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6 papers

Interventional · Nat Med0/3Action Items · Critical / High

An LLM chatbot to facilitate primary-to-specialist care transitions: a randomized controlled trial.

Tao X, Zhou S, Ding K, Li S, Li Y, Wu B, Huang Q, Chen W, Shen M, Meng E, Chen X, Hu H, Zhang J, Zhou J, Zou L, Ma L, Han S

3.25 / 5

Data/code availability incompleteMethods and results do not matchImplausibly large reported effect+1 more

Conclusions

11 supported · 1 partial of 12

2/2 links liveregistered

3 Adcurare Rigor Reviewers · high confidenceAI Rigor Reviewers trained on Adcurare corpus · verify findings

Read paperPMC Journal

Interventional · Nat Med0/7Action Items · Critical / High

AI-based triage and decision support in mammography and digital tomosynthesis for breast cancer screening: a paired, noninferiority trial.

Elías-Cabot E, Romero-Martín S, Raya-Povedano JL, Rodríguez-Ruiz A, Álvarez-Benito M

4 / 5

Biological variables underreported (sex, age, strain)Study-design details incomplete (controls, blinding, power)Internal contradictions in the reported numbers

Conclusions

8 supported · 4 partial of 12

4/4 links liveregistered

3 Adcurare Rigor Reviewers · high confidenceAI Rigor Reviewers trained on Adcurare corpus · verify findings

Read paperPMC Journal

Interventional · Nat Med

A socially assistive robot to support mental wellbeing in LGBTQ+ young people at risk of self-harm: a randomized controlled trial.

Williams AJ, Rhodes CA, Cleare S, Borschmann R, Gross JJ, Petrova K, Posada L, Tench CR, Chapman-Nisar A, Martin L, Hollis C, Townsend E, Slovak P, Digital Youth research team

4.25 / 5

Conclusions overstated beyond the evidenceDead data/code links

Conclusions

7 supported · 4 partial · 1 overstated of 12

8 Rigor Dimensions

8 of 8 pass

Verified

4/6 links livestats consistentregistered

3 Adcurare Rigor ReviewersAI Rigor Reviewers trained on Adcurare corpus · verify findings

Read paperPMC Journal

Interventional · BMJ0/4Action Items · Critical / High

Effect of a clinical decision support system on stroke care quality and outcomes in patients with acute ischaemic stroke (GOLDEN BRIDGE II): cluster randomised clinical trial.

Zhang X, Ding L, Jing J, Wang C, Gu H, Jiang Y, Meng X, Liu T, Xie X, Xu M, Hu M, Zhang Y, Fu H, Liu P, Du C, Du K, Wang M, Li H, Gong X, Dong K, Xiong Y, Wang Y, Liu L, Zhang Z, Zang Y, Yang C, Xian Y, Peterson E, Fonarow GC, Schwamm LH, Zhao X, Wang Y, Li Z, GOLDEN BRIDGE II Investigators

4.25 / 5

Key resources not identifiedEthics/consent reporting incomplete

Conclusions

12 supported of 12

8 Rigor Dimensions

6 of 8 pass · 1 warn · 1 fail

Verified

stats consistentregistered

3 Adcurare Rigor Reviewers · high confidenceAI Rigor Reviewers trained on Adcurare corpus · verify findings

Read paperPMC Journal

Interventional · Nat Med0/6Action Items · Critical / High

Reliability of LLMs as medical assistants for the general public: a randomized preregistered study.

Bean AM, Payne RE, Parsons G, Kirk HR, Ciro J, Mosquera-Gómez R, Hincapié M S, Ekanayaka AS, Tarassenko L, Rocher L, Mahdi A

4.75 / 5

Key resources under-identified (antibodies, cell lines, RRIDs)

4/4 links livestats consistentregistered

3 Adcurare Rigor Reviewers · high confidenceAI Rigor Reviewers trained on Adcurare corpus · verify findings

Read paperPMC Journal

Interventional · Nat Med0/4Action Items · Critical / High

AI-based chest X-ray prioritization in the lung cancer diagnostic pathway: the LungIMPACT randomized controlled trial.

Woznitza N, Smith L, Rawlinson J, Au-Yong I, George B, Djearaman MG, Nair A, Lee RW, Navani N, Ndwandwe S, Clarke CS, Creeden A, Newsome J, Das I, Abaokporo S, Tucker R, Hathorn J, Baldwin DR

2/2 links livestats consistentregistered

3 Adcurare Rigor Reviewers · high confidenceAI Rigor Reviewers trained on Adcurare corpus · verify findings

Read paperPMC Journal

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How to read this. The engine surfaces specific, verifiable rigor problems. It does notpredict retractions, and a “pass” is not a guarantee of soundness. Papers are analyzed on their published full text with any retraction notice removed, so detection is content-based. Real-world outcome labels (retracted, landmark) are curator-assigned from the public record; the verdict and every surfaced problem are the engine’s own. These are selected examples.