Evidence map›Paper›PMID 39317494›Full record

ArticleBMJ open2024

Is personal physiology-based rapid prediction digital twin for minimal effective fentanyl dose better than standard practice: a pilot study protocol.

Milena Cukic, Simon Annaheim, Flora Bahrami, Thijs Defraeye, Katelijne De Nys, Markus Jörger

Abstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing 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

6 citing papers in PubMed.

  1. Review
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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.

Milena CukicLaboratory for Biomimetic Membranes and Textiles, Empa Swiss Federal Labs for Materials Science and Technology, St. Gallen, Switzerland milena.cukic@gmail.com.ORCID 0000-0002-9162-987X
Simon AnnaheimLaboratory for Biomimetic Membranes and Textiles, Empa Swiss Federal Labs for Materials Science and Technology, St. Gallen, Switzerland.
Flora BahramiLaboratory for Biomimetic Membranes and Textiles, Empa Swiss Federal Labs for Materials Science and Technology, St. Gallen, Switzerland.
Thijs DefraeyeLaboratory for Biomimetic Membranes and Textiles, Empa Swiss Federal Labs for Materials Science and Technology, St. Gallen, Switzerland.
Katelijne De NysPalliative Care Department, Kantonal Hospital St. Gallen (KSSG), St. Gallen, Switzerland.
Markus JörgerOncology, Kantonsspital St Gallen, St. Gallen, Switzerland.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionPatients with advanced cancer frequently suffer from chronic, severe disabling pain. Opioids such as morphine and fentanyl are commonly used to manage this pain. Transdermal drug delivery systems are important technologies for administering drugs in a non-invasive, continuous and controlled manner. Due to the narrow therapeutic range of fentanyl, individualised dosing is essential to avoid underdosing or overdosing. Standard clinical calculation tools for opioid rotation however do not include important patient characteristics that account for interindividual variability of opioid pharmacology. METHODS AND ANALYSIS: We developed a clinical protocol to optimise individual fentanyl dosing in patients with advanced cancer switching from oral or intravenous opioids to transdermal fentanyl by using a physics-based digital twin (DT) that is fed by important clinical and physiological parameters. Individual tailoring of transdermal fentanyl therapy is an approach with the potential for personalised and effective care with an improved benefit-risk ratio. However, clinical validation of physics-based digital twins (PBDT) dosing is crucial to proving clinical benefit.Therapeutic drug monitoring will allow to validate the accuracy of PBDT predictions. Additional monitoring for breathing dynamics, sequential pain levels and fentanyl-related adverse events will contribute to evaluating the performance of PBDT-based dosing of transdermal fentanyl. The primary objective of the study is to develop an experimental protocol to validate DT-guided fentanyl dosing in patients with advanced cancer. This clinical study will bring individualised opioid dosing closer to clinical practice. ETHICS AND DISSEMINATION: Study documents have been approved by the responsible Ethics Committee and study initiation is planned for late summer 2024. Data will be shared with the scientific community no more than 1 year following completion of the study and data assembly.

Indexed as

Administration, CutaneousAnalgesics, OpioidFentanylCancer PainDrug MonitoringHumansPilot ProjectsAnalgesics, OpioidFentanylCancer painInformation technologyPain managementPalliative care

Identifiers

PMID39317494
PMCPMC11423737

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Registered trials

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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.