Evidence map›Paper›PMID 40108728›Full record

ArticleTrials2025

A qualitative study to understand the challenges of conducting randomised controlled trials of complex interventions in metastatic colorectal cancer.

Niamh McKigney, Jenny Seligmann, Maureen Twiddy, Simon Bach, Faheez Mohamed, Nicola Fearnhead, Julia M Brown, Deena P Harji

Abstract read
In one paragraph

Article in Trials, 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

8 authors.

Niamh McKigneyClinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK. N.McKigney@leeds.ac.uk.ORCID http://orcid.org/0000-0003-1599-5701
Jenny SeligmannLeeds Institute of Medical Research at St. James's, University of Leeds, St. James's University Hospital, Leeds, UK.
Maureen TwiddyInstitute of Clinical and Applied Health Research, Hull York Medical School, University of Hull, Hull, UK.
Simon BachDepartment of Surgery, University Hospitals Birmingham, Birmingham, UK.
Faheez MohamedPeritoneal Malignancy Institute, Basingstoke and North Hampshire Hospital, Basingstoke, UK.
Nicola FearnheadDepartment of Colorectal Surgery, Cambridge University Hospitals, Cambridge, UK.
Julia M BrownClinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.
Deena P HarjiClinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe use of interventions such as major liver and lung resection, radiofrequency ablation and transarterial chemoembolization in the management of metastatic colorectal cancer (mCRC) is now relatively commonplace in clinical practice. However, the evidence base regarding these treatments is limited with a lack of high-quality data from randomised controlled trials (RCTs). The aim of this study was to understand the challenges associated with conducting RCTs in advanced mCRC and to identify potential strategies to overcome them, with a view to improving trial design and delivery in this setting.

methodsA qualitative study was undertaken with professionals involved in mCRC trials. Participants were identified using trial registries to identify relevant trials. Individual semi-structured, in-depth qualitative interviews were undertaken online using a topic guide. The principles of thematic content analysis were used for data analysis.

resultsTwelve participants were recruited to the study from six trials; three of the trials had completed, two were either terminated or no longer recruiting and one was open to recruitment. Four major themes were identified, and themes were further subdivided to identify specific challenges and solutions to overcome them. The four themes identified were as follows: trial-related processes, organisational/structural challenges, trial design considerations, and stage IV (metastatic) colorectal cancer-specific factors. Significant challenges were described in relation to funding, ethical approval processes, equipoise, patient preferences, logistical issues in trial delivery, and the advanced nature of mCRC including disease progression and palliative care.

conclusionsThere are a range of strategies which could be implemented to improve the delivery of future trials in this complex setting, from the initial development of a trial through to trial setup, recruitment and follow-up.

Indexed as

Colorectal NeoplasmsRandomized Controlled Trials as TopicResearch DesignHumansInterviews as TopicNeoplasm MetastasisNeoplasm StagingPatient SelectionQualitative ResearchTreatment OutcomeChallengesMetastatic colorectal cancerRandomised controlled trials

Identifiers

PMID40108728
PMCPMC11924622

What OpenQuestion holds

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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.