Evidence map›Paper›PMID 30227890›Full record

Trial reportTrials2018

The effect of optimised patient information materials on recruitment in a lung cancer screening trial: an embedded randomised recruitment trial.

Adwoa Parker, Peter Knapp, Shaun Treweek, Vichithranie Madhurasinghe, Roberta Littleford, Stephanie Gallant, Frank Sullivan, Stuart Schembri, Jo Rick, Jonathan Graffy and 4 more

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01925625 (Detection in Blood of Autoantibodies to Tumour Antigens as a Case-finding Method in Lung Cancer Using the EarlyCDT-Lung Test), which is not on this map. Cited by 16 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 3 pooled it
–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.

NCT01925625 nacompletednot on this map

Detection in Blood of Autoantibodies to Tumour Antigens as a Case-finding Method in Lung Cancer Using the EarlyCDT-Lung Test

TypeinterventionalSponsorStuart SchembriRan2013 to 2018Enrolled12,210ConditionsLung CancerArmsEarly CDT Lung blood test
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Strategies to improve recruitment to randomised trials.The Cochrane database of systematic reviews · 2026
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  11. Optimizing the implementation of lung cancer screening in Scotland: Focus group participant perspectives in the LUNGSCOT study.Health expectations : an international journal of public participation in health care and health policy · 2022
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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

14 authors.

Adwoa ParkerYork Trials Unit, Department of Health Sciences, University of York, York, YO10 5DD, UK.ORCID http://orcid.org/0000-0002-2880-3935
Peter KnappDepartment of Health Sciences, Seebohm Rowntree Building, University of York, York, YO10 5DD, UK.
Shaun TreweekHealth Services Research Unit, University of Aberdeen, 3rd Floor, Health Sciences Building, Foresterhill, Aberdeen, AB25 2ZD, UK.
Vichithranie MadhurasingheBlizard Institute, Barts and The London School of Medicine and Dentistry, 4 Newark Street, London, E1 2AT, UK.
Roberta LittlefordTayside Clinical Trials Unit, University of Dundee, Dundee, UK.
Stephanie GallantCentre for Public Health Nutrition Research, University of Dundee, Dundee, UK.
Frank SullivanSchool of Medicine, Medical & Biological Sciences, North Haugh, St Andrews, UK.
Stuart SchembriSchool of Medicine, University of Dundee, Ninewells Hospital & Medical School, Dundee, DD1 9SY, Scotland, UK.
Jo RickMRC North West Hub for Trials Methodology Research, Manchester Academic Health Science Centre, University of Manchester, Williamson Building, Manchester, M13 9PT, UK.
Jonathan GraffyDepartment of Public Health and Primary Care, The Primary Care Unit, University of Cambridge, Cambridge, CB2 OSR, UK.
David J CollierWilliam Harvey Research Institute, Barts and the London Queen Mary University of London, Charterhouse Square, London, EC1M 6BQ, UK.
Sandra EldridgeBlizard Institute, Barts and The London School of Medicine and Dentistry, 4 Newark Street, London, E1 2AT, UK.
Anne KennedyNIHR Collaboration for Leadership in Applied Health Research and Care (CLAHRC) Wessex, Health Sciences, University of Southampton, Highfield, Southampton, SO17 1BJ, UK.
Peter BowerMRC North West Hub for Trials Methodology Research, Manchester Academic Health Science Centre, University of Manchester, Williamson Building, Manchester, M13 9PT, UK. peter.bower@manchester.ac.uk.

Funding

Chief Scientist Office HSRU1Department of Health DRF-2012-05-128Medical Research Council G1002325
6 · The paper itself

Abstract

backgroundWritten participant information materials are important for ensuring that potential trial participants receive necessary information so that they can provide informed consent. However, such materials are frequently long and complex, which may negatively impact patient understanding and willingness to participate. Improving readability, ease of comprehension and presentation may assist with improved participant recruitment. The Systematic Techniques for Assisting Recruitment to Trials (MRC START) study aimed to develop and evaluate interventions to improve trial recruitment. This study aimed to assess the effectiveness of an optimised participant information brochure and cover letter developed by MRC START regarding response and participant recruitment rates.

methodsWe conducted a study within a trial (SWAT) embedded in the EarlyCDT Lung Cancer Scotland (ECLS) trial that aimed to assess the effectiveness of a new test in reducing the incidence of patients with late-stage lung cancer at diagnosis compared with standard care. Potential participants approached for ECLS were randomised to receive the original participant information brochure and accompanying letter (control group) or optimised versions of these materials which had undergone user testing and a process of re-writing, re-organisation and professional graphic design (intervention group). The primary outcome was the number of patients recruited to ECLS. The secondary outcome was the proportion of patients expressing an interest in participating in ECLS.

resultsIn total, 2262 patients were randomised, 1136 of whom were sent the intervention materials and 1126 of whom were sent the control materials. The proportion of patients enrolled and randomised into ECLS was 180 of 1136 (15.8%) in the intervention group and 176 of 1126 (15.6%) in the control group (OR = 1.016, 95% CI, 0.660 to 1.564). The proportion of patients who positively responded to the invitation was 224 of 1136 (19.7%) in the intervention group and 205 of 1126 (18.2%) in the control group (OR = 1.103, 95% CI, 0.778 to 1.565).

conclusionsOptimised patient information materials made little difference to the proportion of patients positively responding to a trial invitation or to the proportion subsequently randomised to the host trial.

trial registrationClinicalTrials.gov, NCT01925625 . Registered on 15 August 2015. Study Within A Trial, SWAT-23. Registered on 12 April 2016.

Indexed as

Patient Education as TopicPatient SelectionAgedAutoantibodiesBiomarkers, TumorComprehensionCorrespondence as TopicEarly Detection of CancerFemaleHealth Knowledge, Attitudes, PracticeHumansIncidenceLung NeoplasmsMaleMiddle AgedNeoplasm StagingAutoantibodiesBiomarkers, TumorPatient informationRandomised controlled trialRecruitmentResearch methodologyStudy within a trial (SWAT)

Identifiers

PMID30227890
PMCPMC6145341

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Registered trials

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.