Evidence map›Paper›PMID 40050060›Full record

ArticleBMJ open2025

Screening to identify people with type 2 diabetes at risk of liver cancer in primary care: a randomised controlled trial protocol.

Ryan M Buchanan, Tina Reinson, Josh Bilson, Hazel Woodland, Chinonso Nwoguh, Keith Cooper, Scott Harris, Karen Malone, Christopher D Byrne

Abstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Ryan M Buchanan *University of Southampton Faculty of Medicine, Southampton, UK ryan.buchanan@soton.ac.uk.ORCID http://orcid.org/0000-0003-0850-5575
Tina Reinson *Clinical and Experimental Sciences Division, University of Southampton Faculty of Medicine, Southampton, UK.ORCID http://orcid.org/0000-0002-2436-1906
Josh BilsonUniversity of Southampton Faculty of Medicine, Southampton, UK.
Hazel WoodlandSalisbury District Hospital NHS Foundation Trust, Salisbury, UK.
Chinonso NwoguhUniversity of Southampton Faculty of Medicine, Southampton, UK.
Keith CooperSouthampton Health Technology Assessment Centre, University of Southampton, Southampton, UK.ORCID http://orcid.org/0000-0002-0318-7670
Scott HarrisUniversity of Southampton Faculty of Medicine, Southampton, UK.
Karen MaloneThe Old Fire Station Surgery, Woolston, UK.
Christopher D ByrneUniversity of Southampton Faculty of Medicine, Southampton, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionHepatocellular carcinoma (HCC) is expected to become the third most common cause of cancer death worldwide by 2030. The increase in HCC is in large part due to the rising prevalence of risk factors such as type 2 diabetes mellitus (T2DM). Up to 1 in 20 people living with T2DM have liver cirrhosis, and they have a 1% to 2% incidence of HCC per year. Patients with cirrhosis enter surveillance for HCC to identify early-stage, curable tumours. A diagnosis of T2DM does not mandate testing to identify patients with cirrhosis, with testing restricted to those with additional risks. There has never been a trial and nested cost-effectiveness evaluation comparing screening all patients with T2DM for cirrhosis against usual care. METHODS AND ANALYSIS: The study will use a multi-centre, unblinded individual randomised controlled trial design. The aim will be to determine the effectiveness and cost-effectiveness of screening all adults with T2DM to identify those at high risk of HCC. The recruitment strategy has been supported by patient and public involvement (PPI). Participants will be identified via an automated search of primary care records and invited to participate via text. 320 participants will be randomised for screening. The screening will include measurement of bio-markers for liver fibrosis (ELF and Fib-4) and vibration-controlled transient elastography. Another 320 participants will be randomised to standard care. Demographic and medical history data will be collected at baseline from all participants. Outcome data will be collected remotely from healthcare records. The primary outcome is the proportion of participants in each arm who are referred to HCC surveillance following testing for liver disease within 12 months of randomisation. The results will be used to calculate the incremental cost-effectiveness ratio of screening via a Markov model. ETHICS AND DISSEMINATION: The results of this study will be presented directly to National Health Service England. Additional dissemination via conference proceedings and publication will be supported by our PPI team. Ethical approval was granted by the West of Scotland Research Ethics Service on 2 August 2023, REC reference 23/WS/0102. TRIAL REGISTRATION NUMBER: ISRCTN17017677.

Indexed as

Carcinoma, HepatocellularDiabetes Mellitus, Type 2Early Detection of CancerLiver CirrhosisLiver NeoplasmsMass ScreeningAdultCost-Benefit AnalysisFemaleHumansMaleMulticenter Studies as TopicPrimary Health CareRandomized Controlled Trials as TopicRisk FactorsDiabetes & endocrinologyHealth Care CostsHepatobiliary tumoursHepatologyRandomised Controlled Trial

Identifiers

PMID40050060
PMCPMC11887308

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.