Evidence map›Paper›PMID 39707238›Full record

ArticleBMC medical research methodology2024

Optimising research investment by simulating and evaluating monitoring strategies to inform a trial: a simulation of liver fibrosis monitoring.

Alice J Sitch, Jacqueline Dinnes, Jenny Hewison, Walter Gregory, Julie Parkes, Jonathan J Deeks

Abstract read
In one paragraph

Article in BMC medical research methodology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

6 authors.

Alice J SitchNational Institute for Health and Care Research (NIHR) Birmingham Biomedical Research Centre, Birmingham, UK. a.j.sitch@bham.ac.uk.
Jacqueline DinnesNational Institute for Health and Care Research (NIHR) Birmingham Biomedical Research Centre, Birmingham, UK.
Jenny HewisonLeeds Institute of Health Sciences, University of Leeds, Leeds, UK.
Walter GregoryDepartment of Oncology and Metabolism, University of Sheffield, Sheffield, UK.
Julie ParkesPrimary Care & Population Sciences Faculty of Medicine, University of Southampton, Southampton, UK.
Jonathan J DeeksNational Institute for Health and Care Research (NIHR) Birmingham Biomedical Research Centre, Birmingham, UK.

Funding

National Institute for Health and Care Research RP-PG-0707-10101
6 · The paper itself

Abstract

backgroundThe aim of the study was to investigate the development of evidence-based monitoring strategies in a population with progressive or recurrent disease. A simulation study of monitoring strategies using a new biomarker (ELF) for the detection of liver cirrhosis in people with known liver fibrosis was undertaken alongside a randomised controlled trial (ELUCIDATE).

methodsExisting data and expert opinion were used to estimate the progression of disease and the performance of repeat testing with ELF. Knowledge of the true disease status in addition to the observed test results for a cohort of simulated patients allowed various monitoring strategies to be implemented, evaluated and validated against trial data.

resultsSeveral monitoring strategies ranging in complexity were successfully modelled and compared regarding the timing of detection of disease, the duration of monitoring, and the predictive value of a positive test result. The results of sensitivity analysis showed the importance of accurate data to inform the simulation. Results of the simulation were similar to those from the trial.

conclusionMonitoring data can be simulated and strategies compared given adequate knowledge of disease progression and test performance. Such exercises should be carried out to ensure optimal strategies are evaluated in trials thus reducing research waste. Monitoring data can be generated and monitoring strategies can be assessed if data is available on the monitoring test performance and the test variability. This work highlights the data necessary and the general method for evaluating the performance of monitoring strategies, allowing appropriate strategies to be selected for evaluation. Modelling work should be conducted prior to full scale investigation of monitoring strategies, allowing optimal monitoring strategies to be assessed.

Indexed as

BiomarkersComputer SimulationDisease ProgressionLiver CirrhosisHumansRandomized Controlled Trials as TopicBiomarkersBiomarkersLiver diseaseMonitoringSurveillanceTests

Identifiers

PMID39707238
PMCPMC11660973

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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.