Evidence map›Paper›PMID 41331751›Full record

ArticleBMC medical ethics2025

How to improve informed consent processes in clinical trials with cancer patients: a qualitative analysis of multidisciplinary experts' perspectives.

Christine Bernardi, Daniel Wolff, Florian Lüke, Johannes Hies, Ruth Horn, Frederike Seitz, Daniel Heudobler, Wolfgang Herr, Anne Herrmann

Abstract read
In one paragraph

Article in BMC medical ethics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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

3 citing papers in PubMed.

  1. Article
  2. Validating LLM judges for automated oversight of patient communication.medRxiv : the preprint server for health sciences · 2026
    Article
  3. Article
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.

Christine BernardiMedical Sociology, Department for Epidemiology and Preventive Medicine, University of Regensburg, Regensburg, Germany. christine.bernardi@klinik.uni-regensburg.de.
Daniel WolffDepartment of Internal Medicine III, University Hospital Regensburg, Regensburg, Germany.
Florian LükeDepartment of Internal Medicine III, University Hospital Regensburg, Regensburg, Germany.
Johannes HiesLegal Department, University Hospital Regensburg, Regensburg, Germany.
Ruth HornInstitute for Ethics and History of Health in Society, Medical Faculty, University of Augsburg, Augsburg, Germany.
Frederike SeitzEthics Committee, University of Regensburg, Regensburg, Germany.
Daniel HeudoblerDepartment of Internal Medicine III, University Hospital Regensburg, Regensburg, Germany.
Wolfgang HerrDepartment of Internal Medicine III, University Hospital Regensburg, Regensburg, Germany.
Anne HerrmannMedical Sociology, Department for Epidemiology and Preventive Medicine, University of Regensburg, Regensburg, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveAccording to legal and ethical obligations, patients must be thoroughly informed about the trial in which they could enrol, requiring them to consider and digest a significant amount of complex information. Many cancer patients feel overwhelmed which hinders their ability to make informed decision regarding their care. There is a need for further evidence-based strategies on how to improve both physician-patient-communication and informed consent (IC) documents in this area. We explored the views of experts from various disciplines on communication in IC processes in oncology.

methodsSeventeen semi-structured interviews with multidisciplinary experts were conducted and analysed using framework analysis.

resultsSeveral experts stated that IC documents have become highly legalistic, often prioritizing the interests of sponsors and further institutions involved over patient understanding. IC conversations are considered essential, as many patients do not thoroughly read IC documents. Conducting an unbiased IC conversation in an understandable manner may be challenging for physicians because they often have vested interests in recruiting patients for trials. Introducing evidence-based checklists for IC conversations and involving nursing staff may assist in addressing practical issues patients may have, reduce anxiety, and increase consent rates. Strategies to improve IC documents include reducing potentially irrelevant information (e.g., on contraception), improving the adaptation of international consent forms to local settings and incorporating graphical abstracts and study flowcharts to offer brief and visually engaging summaries. Additionally, fostering open dialogue and involvement of all relevant stakeholders (including patient representatives from various sociodemographic backgrounds) in designing IC documents may enhance IC processes. Many experts expressed the need for further research on the needs of different target groups, such as individuals with a migrant background or visual or other impairments.

conclusionsThere is a significant gap between legal and ethical obligations related to IC and patients not being able to understand the abundance of unfamiliar, complex information provided to them. Evidence-based IC checklists, involving nursing staff and improved written IC materials may help improve communication in this area. Further interventional research is required to IC processes in oncology with the aim to provide optimal, patient-centred care.

Indexed as

Clinical Trials as TopicCommunicationInformed ConsentNeoplasmsPhysician-Patient RelationsHumansMedical OncologyQualitative ResearchClinical trialEthicsInformed consentOncologySemi-structured interviews

Identifiers

PMID41331751
PMCPMC12690889

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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.